# Official Journal C 132E/2006

| | ISSN 1725-2423 |
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| Official Journal
  of the European Union | C 132E |
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| English edition | Information and Notices | Volume 497 June 2006 |

ISSN 1725-2423

Official Journal

of the European Union

C 132E

English edition

Information and Notices

Volume 497 June 2006

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| Notice No | Contents | page |
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| | I   Information |
| | Council |
| 2006/C 132E/1 | Common Position (EC) No 7/2006 of 10 March 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Regulation of the European Parliament and of the Council on medical products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 | 1 |

Notice No

Contents

page

I   Information

Council

2006/C 132E/1

Common Position (EC) No 7/2006 of 10 March 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Regulation of the European Parliament and of the Council on medical products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004

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I Information

Council

| 7.6.2006 | EN | Official Journal of the European Union | CE 132/1 |
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7.6.2006

EN

Official Journal of the European Union

CE 132/1

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COMMON POSITION (EC) No 7/2006

adopted by the Council on 10 May 2006

with a view to adopting Regulation (EC) No .../2006 of the European Parliament and of the Council of ... on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004

(2006/C 132 E/01)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure referred to in Article 251 of the Treaty (2),

Whereas:

| (1) | Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population. |
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(1)

Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population.

| (2) | Such studies may not have been undertaken for use in the paediatric population and many of the medicinal products currently used to treat the paediatric population have not been studied or authorised for such use. Market forces alone have proven insufficient to stimulate adequate research into, and the development and authorisation of, medicinal products for the paediatric population. |
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(2)

Such studies may not have been undertaken for use in the paediatric population and many of the medicinal products currently used to treat the paediatric population have not been studied or authorised for such use. Market forces alone have proven insufficient to stimulate adequate research into, and the development and authorisation of, medicinal products for the paediatric population.

| (3) | Problems resulting from the absence of suitably adapted medicinal products for the paediatric population include inadequate dosage information which leads to increased risks of adverse reactions including death, ineffective treatment through under-dosage, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration, as well as use of magistral or officinal formulations to treat the paediatric population which may be of poor quality. |
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(3)

Problems resulting from the absence of suitably adapted medicinal products for the paediatric population include inadequate dosage information which leads to increased risks of adverse reactions including death, ineffective treatment through under-dosage, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration, as well as use of magistral or officinal formulations to treat the paediatric population which may be of poor quality.

| (4) | This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations. These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations. |
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(4)

This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations. These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations.

| (5) | While taking into account the fact that the regulation of medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Community. The differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market. |
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(5)

While taking into account the fact that the regulation of medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Community. The differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market.

| (6) | The establishment of a system of both obligations and rewards and incentives has proved necessary to achieve these objectives. The precise nature of these obligations and rewards and incentives should take account of the status of the particular medicinal product concerned. This Regulation should apply to all the medicinal products required for paediatric use and therefore its scope should cover products under development and yet-to-be authorised, authorised products covered by intellectual property rights and authorised products no longer covered by intellectual property rights. |
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(6)

The establishment of a system of both obligations and rewards and incentives has proved necessary to achieve these objectives. The precise nature of these obligations and rewards and incentives should take account of the status of the particular medicinal product concerned. This Regulation should apply to all the medicinal products required for paediatric use and therefore its scope should cover products under development and yet-to-be authorised, authorised products covered by intellectual property rights and authorised products no longer covered by intellectual property rights.

| (7) | Any concerns about conducting trials in the paediatric population should be balanced by the ethical concerns about giving medicinal products to a population in which they have not been appropriately tested. Public health threats from the use of untested medicinal products in the paediatric population can be safely addressed through the study of medicinal products for the paediatric population, which should be carefully controlled and monitored through the specific requirements for the protection of the paediatric population who take part in clinical trials in the Community laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (3) |
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(7)

Any concerns about conducting trials in the paediatric population should be balanced by the ethical concerns about giving medicinal products to a population in which they have not been appropriately tested. Public health threats from the use of untested medicinal products in the paediatric population can be safely addressed through the study of medicinal products for the paediatric population, which should be carefully controlled and monitored through the specific requirements for the protection of the paediatric population who take part in clinical trials in the Community laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (3)

| (8) | It is appropriate to create a scientific committee, the Paediatric Committee, within the European Medicines Agency, hereinafter ’the Agency’, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations. To this end, the Paediatric Committee should be independent from the pharmaceutical industry. The Paediatric Committee should be primarily responsible for the scientific assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof; it should also be central to various support measures contained in this Regulation. In its work, the Paediatric Committee should consider the potential significant therapeutic benefits for the paediatric patients involved in the studies or the paediatric population at large including the need to avoid unnecessary studies. The Paediatric Committee should follow existing Community requirements, including Directive 2001/20/EC, as well as International Conference on Harmonisation (ICH) guideline E11 on the development of medicinal products for the paediatric population, and it should avoid any delay in the authorisation of medicinal products for other populations deriving from the requirements for studies in the paediatric population. |
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(8)

It is appropriate to create a scientific committee, the Paediatric Committee, within the European Medicines Agency, hereinafter ’the Agency’, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations. To this end, the Paediatric Committee should be independent from the pharmaceutical industry. The Paediatric Committee should be primarily responsible for the scientific assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof; it should also be central to various support measures contained in this Regulation. In its work, the Paediatric Committee should consider the potential significant therapeutic benefits for the paediatric patients involved in the studies or the paediatric population at large including the need to avoid unnecessary studies. The Paediatric Committee should follow existing Community requirements, including Directive 2001/20/EC, as well as International Conference on Harmonisation (ICH) guideline E11 on the development of medicinal products for the paediatric population, and it should avoid any delay in the authorisation of medicinal products for other populations deriving from the requirements for studies in the paediatric population.

| (9) | Procedures should be established for the Agency to agree and modify a paediatric investigation plan, which is the document upon which the development and authorisation of medicinal products for the paediatric population should be based. The paediatric investigation plan should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population. Since the paediatric population is in fact composed of a number of population subsets, the paediatric investigation plan should specify which population subsets need to be studied, by what means and by when. |
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(9)

Procedures should be established for the Agency to agree and modify a paediatric investigation plan, which is the document upon which the development and authorisation of medicinal products for the paediatric population should be based. The paediatric investigation plan should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population. Since the paediatric population is in fact composed of a number of population subsets, the paediatric investigation plan should specify which population subsets need to be studied, by what means and by when.

| (10) | The introduction of the paediatric investigation plan in the legal framework concerning medicinal products for human use aims at ensuring that the development of medicinal products that are potentially to be used for the paediatric population becomes an integral part of the development of medicinal products, integrated into the development programme for adults. Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population before marketing authorisation applications are submitted. It is appropriate to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee. As the development of medicinal products is a dynamic process dependent on the result of ongoing studies, provision should be made for modifying an agreed plan where necessary. |
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(10)

The introduction of the paediatric investigation plan in the legal framework concerning medicinal products for human use aims at ensuring that the development of medicinal products that are potentially to be used for the paediatric population becomes an integral part of the development of medicinal products, integrated into the development programme for adults. Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population before marketing authorisation applications are submitted. It is appropriate to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee. As the development of medicinal products is a dynamic process dependent on the result of ongoing studies, provision should be made for modifying an agreed plan where necessary.

| (11) | It is necessary to introduce a requirement for new medicinal products and for authorised medicinal products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new indication, new pharmaceutical form or new route of administration. The paediatric investigation plan should be the basis upon which compliance with that requirement is judged. However, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, nor to homeopathic medicinal products and traditional herbal medicinal products authorised through the simplified registration procedures of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4). |
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(11)

It is necessary to introduce a requirement for new medicinal products and for authorised medicinal products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new indication, new pharmaceutical form or new route of administration. The paediatric investigation plan should be the basis upon which compliance with that requirement is judged. However, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, nor to homeopathic medicinal products and traditional herbal medicinal products authorised through the simplified registration procedures of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4).

| (12) | Provision should be made for research into the paediatric use of medicinal products which are not protected by a patent or supplementary protection certificate to be financed under Community research programmes. |
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(12)

Provision should be made for research into the paediatric use of medicinal products which are not protected by a patent or supplementary protection certificate to be financed under Community research programmes.

| (13) | In order to ensure that research in the paediatric population is only conducted to meet their therapeutic needs, there is a need to establish procedures for the Agency to waive the requirement referred to in recital 11 for specific products or for classes or part of classes of medicinal products, these waivers being then made public by the Agency. As knowledge of science and medicine evolves over time, provision should be made for the lists of waivers to be amended. However, if a waiver is revoked, that requirement should not apply for a given period in order to allow time for at least a paediatric investigation plan to be agreed and studies in the paediatric population to be initiated before an application for marketing authorisation is submitted. |
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(13)

In order to ensure that research in the paediatric population is only conducted to meet their therapeutic needs, there is a need to establish procedures for the Agency to waive the requirement referred to in recital 11 for specific products or for classes or part of classes of medicinal products, these waivers being then made public by the Agency. As knowledge of science and medicine evolves over time, provision should be made for the lists of waivers to be amended. However, if a waiver is revoked, that requirement should not apply for a given period in order to allow time for at least a paediatric investigation plan to be agreed and studies in the paediatric population to be initiated before an application for marketing authorisation is submitted.

| (14) | In certain cases, the Agency should defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan, with a view to ensuring that research is conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations. |
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(14)

In certain cases, the Agency should defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan, with a view to ensuring that research is conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations.

| (15) | Free scientific advice should be provided by the Agency as an incentive to sponsors developing medicinal products for the paediatric population. To ensure scientific consistency, the Agency should manage the interface between the Paediatric Committee and the Scientific Advice Working Group of the Committee for Medicinal Products for Human Use, as well as the interaction between the Paediatric Committee and the other Community committees and working groups concerning medicinal products. |
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(15)

Free scientific advice should be provided by the Agency as an incentive to sponsors developing medicinal products for the paediatric population. To ensure scientific consistency, the Agency should manage the interface between the Paediatric Committee and the Scientific Advice Working Group of the Committee for Medicinal Products for Human Use, as well as the interaction between the Paediatric Committee and the other Community committees and working groups concerning medicinal products.

| (16) | The existing procedures for the marketing authorisation of medicinal products for human use should not be changed. However, from the requirement referred to in recital 11 it follows that competent authorities should check compliance with the agreed paediatric investigation plan and any waivers and deferrals at the existing validation step for marketing authorisation applications. The assessment of quality, safety and efficacy of medicinal products for the paediatric population and the granting of marketing authorisations should remain the remit of the competent authorities. Provision should be made for the Paediatric Committee to be asked for its opinion on compliance and on the quality, safety and efficacy of a medicinal product in the paediatric population. |
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(16)

The existing procedures for the marketing authorisation of medicinal products for human use should not be changed. However, from the requirement referred to in recital 11 it follows that competent authorities should check compliance with the agreed paediatric investigation plan and any waivers and deferrals at the existing validation step for marketing authorisation applications. The assessment of quality, safety and efficacy of medicinal products for the paediatric population and the granting of marketing authorisations should remain the remit of the competent authorities. Provision should be made for the Paediatric Committee to be asked for its opinion on compliance and on the quality, safety and efficacy of a medicinal product in the paediatric population.

| (17) | To provide healthcare professionals and patients with information on the safe and effective use of medicinal products in the paediatric population and as a transparency measure, information on the results of studies in the paediatric population, as well as on the status of the paediatric investigation plans, waivers and deferrals, should be included in product information. When all the measures in the paediatric investigation plan have been complied with, that fact should be recorded in the marketing authorisation, and should then be the basis upon which companies can obtain the rewards for compliance. |
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(17)

To provide healthcare professionals and patients with information on the safe and effective use of medicinal products in the paediatric population and as a transparency measure, information on the results of studies in the paediatric population, as well as on the status of the paediatric investigation plans, waivers and deferrals, should be included in product information. When all the measures in the paediatric investigation plan have been complied with, that fact should be recorded in the marketing authorisation, and should then be the basis upon which companies can obtain the rewards for compliance.

| (18) | In order to identify medicinal products authorised for use in the paediatric population and enable their prescription, provision should be made for the labels of medicinal products granted an indication for use in the paediatric population to display a symbol which will be selected by the Commission on a recommendation by the Paediatric Committee. |
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(18)

In order to identify medicinal products authorised for use in the paediatric population and enable their prescription, provision should be made for the labels of medicinal products granted an indication for use in the paediatric population to display a symbol which will be selected by the Commission on a recommendation by the Paediatric Committee.

| (19) | In order to establish incentives for authorised products no longer covered by intellectual property rights, it is necessary to establish a new type of marketing authorisation, the Paediatric Use Marketing Authorisation. A Paediatric Use Marketing Authorisation should be granted through existing marketing authorisation procedures but should apply specifically for medicinal products developed exclusively for use in the paediatric population. It should be possible for the name of the medicinal product that has been granted a Paediatric Use Marketing Authorisation to retain the existing brand name of the corresponding product authorised for adults, in order to capitalise on existing brand recognition, while benefiting from the data exclusivity associated with a new marketing authorisation. |
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(19)

In order to establish incentives for authorised products no longer covered by intellectual property rights, it is necessary to establish a new type of marketing authorisation, the Paediatric Use Marketing Authorisation. A Paediatric Use Marketing Authorisation should be granted through existing marketing authorisation procedures but should apply specifically for medicinal products developed exclusively for use in the paediatric population. It should be possible for the name of the medicinal product that has been granted a Paediatric Use Marketing Authorisation to retain the existing brand name of the corresponding product authorised for adults, in order to capitalise on existing brand recognition, while benefiting from the data exclusivity associated with a new marketing authorisation.

| (20) | An application for a Paediatric Use Marketing Authorisation should include the submission of data concerning use of the product in the paediatric population, collected in accordance with an agreed paediatric investigation plan. These data may be derived from the published literature or from new studies. An application for a Paediatric Use Marketing Authorisation should also be able to refer to data contained in the dossier of a medicinal product which is or has been authorised in the Community. This is intended to provide an additional incentive to encourage small and medium-sized enterprises, including generic companies, to develop off-patent medicinal products for the paediatric population. |
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(20)

An application for a Paediatric Use Marketing Authorisation should include the submission of data concerning use of the product in the paediatric population, collected in accordance with an agreed paediatric investigation plan. These data may be derived from the published literature or from new studies. An application for a Paediatric Use Marketing Authorisation should also be able to refer to data contained in the dossier of a medicinal product which is or has been authorised in the Community. This is intended to provide an additional incentive to encourage small and medium-sized enterprises, including generic companies, to develop off-patent medicinal products for the paediatric population.

| (21) | This Regulation should include measures to maximise access by the Community population to new medicinal products tested and adapted for paediatric use, and to minimise the chance of Community-wide rewards and incentives being granted without sections of the Community paediatric population benefiting from the availability of a newly authorised medicine. An application for a marketing authorisation, including an application for a Paediatric Use Marketing Authorisation, which contains the results of studies conducted in compliance with an agreed paediatric investigation plan should be eligible for the Community centralised procedure set out in Articles 5 to 15 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (5). |
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(21)

This Regulation should include measures to maximise access by the Community population to new medicinal products tested and adapted for paediatric use, and to minimise the chance of Community-wide rewards and incentives being granted without sections of the Community paediatric population benefiting from the availability of a newly authorised medicine. An application for a marketing authorisation, including an application for a Paediatric Use Marketing Authorisation, which contains the results of studies conducted in compliance with an agreed paediatric investigation plan should be eligible for the Community centralised procedure set out in Articles 5 to 15 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (5).

| (22) | When an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other indications, the marketing authorisation holder should be obliged to place the product on the market, taking into account the paediatric information, within two years of the date of approval of the indication. That requirement should relate only to products already authorised, but not to medicinal products authorised via a Paediatric Use Marketing Authorisation. |
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(22)

When an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other indications, the marketing authorisation holder should be obliged to place the product on the market, taking into account the paediatric information, within two years of the date of approval of the indication. That requirement should relate only to products already authorised, but not to medicinal products authorised via a Paediatric Use Marketing Authorisation.

| (23) | An optional procedure should be established to make it possible to obtain a single Community-wide opinion for a nationally authorised medicinal product when data on the paediatric population following an agreed paediatric investigation plan form part of the marketing authorisation application. To achieve this, the procedure set out in Articles 32, 33 and 34 of Directive 2001/83/EC could be used. This will allow the adoption of a Community harmonised Decision on use of that medicinal product in the paediatric population and its inclusion in all national product information. |
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(23)

An optional procedure should be established to make it possible to obtain a single Community-wide opinion for a nationally authorised medicinal product when data on the paediatric population following an agreed paediatric investigation plan form part of the marketing authorisation application. To achieve this, the procedure set out in Articles 32, 33 and 34 of Directive 2001/83/EC could be used. This will allow the adoption of a Community harmonised Decision on use of that medicinal product in the paediatric population and its inclusion in all national product information.

| (24) | It is essential to ensure that pharmacovigilance mechanisms are adapted to meet the specific challenges of collecting safety data in the paediatric population, including data on possible long-term effects. Efficacy in the paediatric population may also need additional study following authorisation. Therefore, an additional requirement for applying for a marketing authorisation that includes the results of studies conducted in compliance with an agreed paediatric investigation plan should be an obligation for the applicant to indicate how he proposes to ensure the long-term follow-up of possible adverse reactions to the use of the medicinal product and efficacy in the paediatric population. Additionally, where there is a particular cause for concern, provision should be made for the possibility of requiring the applicant to submit and implement a risk management system and/or perform specific post-marketing studies as a condition for the granting of the marketing authorisation. |
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(24)

It is essential to ensure that pharmacovigilance mechanisms are adapted to meet the specific challenges of collecting safety data in the paediatric population, including data on possible long-term effects. Efficacy in the paediatric population may also need additional study following authorisation. Therefore, an additional requirement for applying for a marketing authorisation that includes the results of studies conducted in compliance with an agreed paediatric investigation plan should be an obligation for the applicant to indicate how he proposes to ensure the long-term follow-up of possible adverse reactions to the use of the medicinal product and efficacy in the paediatric population. Additionally, where there is a particular cause for concern, provision should be made for the possibility of requiring the applicant to submit and implement a risk management system and/or perform specific post-marketing studies as a condition for the granting of the marketing authorisation.

| (25) | It is necessary in the interests of public health to ensure the continuing availability of safe and effective medicinal products authorised for paediatric indications developed as a result of this Regulation. If a marketing authorisation holder intends to withdraw such a medicinal product from the market then arrangements should be in place so that the paediatric population can continue to have access to the medicinal product in question. In order to help achieve this, the Agency should be informed in good time of any such intention and should make that intention public. |
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(25)

It is necessary in the interests of public health to ensure the continuing availability of safe and effective medicinal products authorised for paediatric indications developed as a result of this Regulation. If a marketing authorisation holder intends to withdraw such a medicinal product from the market then arrangements should be in place so that the paediatric population can continue to have access to the medicinal product in question. In order to help achieve this, the Agency should be informed in good time of any such intention and should make that intention public.

| (26) | For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed paediatric investigation plan are complied with, if the product is authorised in all Member States and if relevant information on the results of studies is included in product information, a reward should be granted in the form of a 6-month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92 (6). |
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(26)

For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed paediatric investigation plan are complied with, if the product is authorised in all Member States and if relevant information on the results of studies is included in product information, a reward should be granted in the form of a 6-month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92 (6).

| (27) | An application for an extension of the duration of the certificate pursuant to this Regulation should only be admissible where a certificate is granted pursuant to Regulation (EEC) No 1768/92. |
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(27)

An application for an extension of the duration of the certificate pursuant to this Regulation should only be admissible where a certificate is granted pursuant to Regulation (EEC) No 1768/92.

| (28) | Because the reward is for conducting studies in the paediatric population and not for demonstrating that a product is safe and effective in the paediatric population, the reward should be granted even when a paediatric indication is not authorised. However, to improve the information available on the use of medicinal products in the paediatric population, relevant information on use in paediatric populations should be included in authorised product information. |
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(28)

Because the reward is for conducting studies in the paediatric population and not for demonstrating that a product is safe and effective in the paediatric population, the reward should be granted even when a paediatric indication is not authorised. However, to improve the information available on the use of medicinal products in the paediatric population, relevant information on use in paediatric populations should be included in authorised product information.

| (29) | Under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (7), medicinal products designated as orphan medicinal products gain 10 years of market exclusivity on the granting of a marketing authorisation for the orphan indication. As such products are frequently not patent-protected, the reward of supplementary protection certificate extension cannot be applied; when they are patent-protected, such an extension would provide a double incentive. Therefore, for orphan medicinal products, instead of an extension of the supplementary protection certificate, the 10-year period of orphan market exclusivity should be extended to twelve years if the requirement for data on use in the paediatric population is fully met. |
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(29)

Under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (7), medicinal products designated as orphan medicinal products gain 10 years of market exclusivity on the granting of a marketing authorisation for the orphan indication. As such products are frequently not patent-protected, the reward of supplementary protection certificate extension cannot be applied; when they are patent-protected, such an extension would provide a double incentive. Therefore, for orphan medicinal products, instead of an extension of the supplementary protection certificate, the 10-year period of orphan market exclusivity should be extended to twelve years if the requirement for data on use in the paediatric population is fully met.

| (30) | The measures provided for in this Regulation should not preclude the operation of other incentives or rewards. To ensure transparency on the different measures available at Community and Member State levels, the Commission should draw up a detailed list of all the incentives available, on the basis of information provided by the Member States. The measures set out in this Regulation, including the agreement of paediatric investigation plans, should not be grounds for obtaining any other Community incentives to support research, such as the funding of research projects under the multi-annual Community Framework Programmes for Research, Technological Development and Demonstration Activities. |
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(30)

The measures provided for in this Regulation should not preclude the operation of other incentives or rewards. To ensure transparency on the different measures available at Community and Member State levels, the Commission should draw up a detailed list of all the incentives available, on the basis of information provided by the Member States. The measures set out in this Regulation, including the agreement of paediatric investigation plans, should not be grounds for obtaining any other Community incentives to support research, such as the funding of research projects under the multi-annual Community Framework Programmes for Research, Technological Development and Demonstration Activities.

| (31) | In order to increase the availability of information on the use of medicinal products in the paediatric population, and to avoid unnecessary repetition of studies in the paediatric population which do not add to the collective knowledge, the European database provided for in Article 11 of Directive 2001/20/EC should include a European register of clinical trials of medicinal products for paediatric use comprising all ongoing, prematurely terminated, and completed paediatric studies conducted both in the Community and in third countries. Part of the information concerning paediatric clinical trials entered into the database, as well as details of the results of all paediatric clinical trials submitted to the competent authorities, should be made public by the Agency. |
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(31)

In order to increase the availability of information on the use of medicinal products in the paediatric population, and to avoid unnecessary repetition of studies in the paediatric population which do not add to the collective knowledge, the European database provided for in Article 11 of Directive 2001/20/EC should include a European register of clinical trials of medicinal products for paediatric use comprising all ongoing, prematurely terminated, and completed paediatric studies conducted both in the Community and in third countries. Part of the information concerning paediatric clinical trials entered into the database, as well as details of the results of all paediatric clinical trials submitted to the competent authorities, should be made public by the Agency.

| (32) | An inventory of the therapeutic needs of the paediatric population should be established by the Paediatric Committee after consultation with the Commission, the Member States and interested parties, and should be regularly updated. The inventory should identify the existing medicinal products used by the paediatric population and highlight the therapeutic needs of that population and the priorities for research and development. In this way, companies should be able easily to identify opportunities for business development; the Paediatric Committee should be able better to judge the need for medicinal products and studies when assessing draft paediatric investigation plans, waivers and deferrals; and healthcare professionals and patients should have an information source available to support their decisions as to which medicinal products to choose. |
| --- | --- |

(32)

An inventory of the therapeutic needs of the paediatric population should be established by the Paediatric Committee after consultation with the Commission, the Member States and interested parties, and should be regularly updated. The inventory should identify the existing medicinal products used by the paediatric population and highlight the therapeutic needs of that population and the priorities for research and development. In this way, companies should be able easily to identify opportunities for business development; the Paediatric Committee should be able better to judge the need for medicinal products and studies when assessing draft paediatric investigation plans, waivers and deferrals; and healthcare professionals and patients should have an information source available to support their decisions as to which medicinal products to choose.

| (33) | Clinical trials in the paediatric population may require specific expertise, specific methodology and, in some cases, specific facilities and should be carried out by appropriately trained investigators. A network, which links existing national and Community initiatives and study centres in order to build up the necessary competences at Community level, and which takes account of Community and third country data, would help facilitate cooperation and avoid unnecessary duplication of studies. This network should contribute to the work of strengthening the foundations of the European Research Area in the context of Community Framework Programmes for Research, Technological Development and Demonstration Activities, benefit the paediatric population and provide a source of information and expertise for industry. |
| --- | --- |

(33)

Clinical trials in the paediatric population may require specific expertise, specific methodology and, in some cases, specific facilities and should be carried out by appropriately trained investigators. A network, which links existing national and Community initiatives and study centres in order to build up the necessary competences at Community level, and which takes account of Community and third country data, would help facilitate cooperation and avoid unnecessary duplication of studies. This network should contribute to the work of strengthening the foundations of the European Research Area in the context of Community Framework Programmes for Research, Technological Development and Demonstration Activities, benefit the paediatric population and provide a source of information and expertise for industry.

| (34) | For certain authorised products, pharmaceutical companies may already hold data on safety or efficacy in the paediatric population. To improve the information available on the use of medicinal products in the paediatric populations, companies holding such data should be required to submit them to all competent authorities where the product is authorised. In this way the data could be assessed and, if appropriate, information should be included in the authorised product information aimed at healthcare professionals and patients. |
| --- | --- |

(34)

For certain authorised products, pharmaceutical companies may already hold data on safety or efficacy in the paediatric population. To improve the information available on the use of medicinal products in the paediatric populations, companies holding such data should be required to submit them to all competent authorities where the product is authorised. In this way the data could be assessed and, if appropriate, information should be included in the authorised product information aimed at healthcare professionals and patients.

| (35) | Community funding should be provided to cover all aspects of the work of the Paediatric Committee and of the Agency resulting from the implementation of this Regulation, such as the assessment of paediatric investigation plans, fee waivers for scientific advice, and information and transparency measures, including the database of paediatric studies and the network. |
| --- | --- |

(35)

Community funding should be provided to cover all aspects of the work of the Paediatric Committee and of the Agency resulting from the implementation of this Regulation, such as the assessment of paediatric investigation plans, fee waivers for scientific advice, and information and transparency measures, including the database of paediatric studies and the network.

| (36) | The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. (8) |
| --- | --- |

(36)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. (8)

| (37) | Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 should therefore be amended accordingly. |
| --- | --- |

(37)

Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 should therefore be amended accordingly.

| (38) | Since the objective of this Regulation, namely improving availability of medicinal products tested for paediatric use, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, given that this will make it possible to take advantage of the widest possible market and avoid the dispersion of limited resources, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve this objective, |
| --- | --- |

(38)

Since the objective of this Regulation, namely improving availability of medicinal products tested for paediatric use, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, given that this will make it possible to take advantage of the widest possible market and avoid the dispersion of limited resources, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve this objective,

HAVE ADOPTED THIS REGULATION:

TITLE I

INTRODUCTORY PROVISIONS

CHAPTER 1

Subject matter and definitions

Article 1

This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting the paediatric population to unnecessary clinical or other trials and in compliance with Directive 2001/20/EC.

Article 2

In addition to the definitions laid down in Article 1 of Directive 2001/83/EC, the following definitions shall apply for the purposes of this Regulation:

| 1. | ‘paediatric population’ means that part of the population aged between birth and 18 years; |
| --- | --- |

1.

‘paediatric population’ means that part of the population aged between birth and 18 years;

| 2. | ‘paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population; |
| --- | --- |

2.

‘paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population;

| 3. | ‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics drawn up in accordance with Article 11 of Directive 2001/83/EC; |
| --- | --- |

3.

‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics drawn up in accordance with Article 11 of Directive 2001/83/EC;

| 4. | ‘paediatric use marketing authorisation’ means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product. |
| --- | --- |

4.

‘paediatric use marketing authorisation’ means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product.

CHAPTER 2

Paediatric Committee

Article 3

1.   By ... (9), a Paediatric Committee shall be established within the European Medicines Agency set up under Regulation (EC) No 726/2004, hereinafter ’the Agency’. The Paediatric Committee shall be considered as established once the members referred to in Article 4(1)(a) and (b) have been appointed.

The Agency shall fulfil the secretariat functions for the Paediatric Committee and shall provide it with technical and scientific support.

2.   Save where otherwise provided for in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee.

3.   The Executive Director of the Agency shall ensure appropriate coordination between the Paediatric Committee and the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.

The Agency shall draw up specific procedures for possible consultations between them.

Article 4

1.   The Paediatric Committee shall be composed of the following members:

| (a) | five members, with their alternates, of the Committee for Medicinal Products for Human Use, having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No 726/2004. These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use; |
| --- | --- |

(a)

five members, with their alternates, of the Committee for Medicinal Products for Human Use, having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No 726/2004. These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use;

| (b) | one member and one alternate appointed by each Member State whose national competent authority is not represented through the members appointed by the Committee for Medicinal Products for Human Use; |
| --- | --- |

(b)

one member and one alternate appointed by each Member State whose national competent authority is not represented through the members appointed by the Committee for Medicinal Products for Human Use;

| (c) | three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent health professionals; |
| --- | --- |

(c)

three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent health professionals;

| (d) | three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient associations. |
| --- | --- |

(d)

three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient associations.

The alternates shall represent and vote for the members in their absence.

For the purposes of points (a) and (b), Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Paediatric Committee, including members and alternates, covers the scientific areas relevant to paediatric medicinal products, and including at least: pharmaceutical development, paediatric medicine, general practitioners, paediatric pharmacy, paediatric pharmacology, paediatric research, pharmacovigilance, ethics and public health. For the purposes of points (c) and (d), the Commission shall take into account the expertise provided by the members appointed under points (a) and (b).

2.   The members of the Paediatric Committee shall be appointed for a renewable period of three years. At meetings of the Paediatric Committee, they may be accompanied by experts.

3.   The Paediatric Committee shall elect its Chairman from among its members for a term of three years, renewable once.

4.   The names and qualifications of the members shall be made public by the Agency.

Article 5

1.   When preparing its opinions, the Paediatric Committee shall use its best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the Paediatric Committee shall adopt an opinion consisting of the position of the majority of the members. The opinion shall mention the divergent positions, with the grounds on which they are based.

2.   The Paediatric Committee shall draw up its rules of procedure for the implementation of its tasks. The rules of procedure shall enter into force after receiving a favourable opinion from the Management Board of the Agency and, subsequently, from the Commission.

3.   All meetings of the Paediatric Committee may be attended by representatives of the Commission, the Executive Director of the Agency or his representatives.

Article 6

1.   The tasks of the Paediatric Committee shall include the following:

| (a) | to assess the content of any paediatric investigation plan for a medicinal product submitted to it in accordance with this Regulation and formulate an opinion thereon; |
| --- | --- |

(a)

to assess the content of any paediatric investigation plan for a medicinal product submitted to it in accordance with this Regulation and formulate an opinion thereon;

| (b) | to assess waivers and deferrals and formulate an opinion thereon; |
| --- | --- |

(b)

to assess waivers and deferrals and formulate an opinion thereon;

| (c) | at the request of the Committee for Medicinal Products for Human Use, a competent authority or the applicant, to assess compliance of the application for a Marketing Authorisation with the concerned agreed paediatric investigation plan and formulate an opinion thereon; |
| --- | --- |

(c)

at the request of the Committee for Medicinal Products for Human Use, a competent authority or the applicant, to assess compliance of the application for a Marketing Authorisation with the concerned agreed paediatric investigation plan and formulate an opinion thereon;

| (d) | at the request of the Committee for Medicinal Products for Human Use or a competent authority, to assess any data generated in accordance with an agreed paediatric investigation plan and formulate an opinion on the quality, safety or efficacy of the medicinal product for use in the paediatric population; |
| --- | --- |

(d)

at the request of the Committee for Medicinal Products for Human Use or a competent authority, to assess any data generated in accordance with an agreed paediatric investigation plan and formulate an opinion on the quality, safety or efficacy of the medicinal product for use in the paediatric population;

| (e) | to advise on the content and format of data to be collected for the survey referred to in Article 42; |
| --- | --- |

(e)

to advise on the content and format of data to be collected for the survey referred to in Article 42;

| (f) | to support and advise the Agency on establishing the European network referred to in Article 44; |
| --- | --- |

(f)

to support and advise the Agency on establishing the European network referred to in Article 44;

| (g) | to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation; |
| --- | --- |

(g)

to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;

| (h) | to provide advice on any question related to medicinal products for use in the paediatric population, at the request of the Executive Director of the Agency or the Commission; |
| --- | --- |

(h)

to provide advice on any question related to medicinal products for use in the paediatric population, at the request of the Executive Director of the Agency or the Commission;

| (i) | to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis, as referred to in Article 43; |
| --- | --- |

(i)

to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis, as referred to in Article 43;

| (j) | to advise the Agency and the Commission regarding the communication of arrangements available for conducting research into medicinal products for use in the paediatric population; |
| --- | --- |

(j)

to advise the Agency and the Commission regarding the communication of arrangements available for conducting research into medicinal products for use in the paediatric population;

| (k) | to make a recommendation to the Commission on the symbol referred to in Article 32(2). |
| --- | --- |

(k)

to make a recommendation to the Commission on the symbol referred to in Article 32(2).

2.   When carrying out its tasks, the Paediatric Committee shall consider whether or not any proposed studies can be expected to be of significant therapeutic benefit to and/or fulfil a therapeutic need of the paediatric population. The Paediatric Committee shall take into account any information available to it, including any opinions, decisions or advice given by the competent authorities of third countries.

TITLE II

MARKETING AUTHORISATION REQUIREMENTS

CHAPTER 1

General authorisation requirements

Article 7

1.   An application for marketing authorisation under Article 6 of Directive 2001/83/EC in respect of a medicinal product for human use which is not authorised in the Community at the time of entry into force of this Regulation shall be regarded as valid only if it includes, in addition to the particulars and documents referred to in Article 8(3) of Directive 2001/83/EC, one of the following:

| (a) | the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan; |
| --- | --- |

(a)

the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;

| (b) | a decision of the Agency granting a product-specific waiver; |
| --- | --- |

(b)

a decision of the Agency granting a product-specific waiver;

| (c) | a decision of the Agency granting a class waiver pursuant to Article 11; |
| --- | --- |

(c)

a decision of the Agency granting a class waiver pursuant to Article 11;

| (d) | a decision of the Agency granting a deferral. |
| --- | --- |

(d)

a decision of the Agency granting a deferral.

For the purposes of point (a), the decision of the Agency agreeing the paediatric investigation plan concerned shall also be included in the application.

2.   The documents submitted pursuant to paragraph 1 shall, cumulatively, cover all subsets of the paediatric population.

Article 8

In the case of authorised medicinal products which are protected either by a supplementary protection certificate under Regulation (EEC) No 1768/92, or by a patent which qualifies for the granting of the supplementary protection certificate, Article 7 of this Regulation shall apply to applications for authorisation of new indications, including paediatric indications, new pharmaceutical forms and new routes of administration.

For the purposes of the first subparagraph, the documents referred to in Article 7(1) shall cover both the existing and the new indications, pharmaceutical forms and routes of administration.

Article 9

Articles 7 and 8 shall not apply to products authorised under Articles 10, 10a, 13 to 16 or 16a to 16i of Directive 2001/83/EC.

Article 10

In consultation with the Member States, the Agency and other interested parties, the Commission shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals must follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 23 and 28(3).

CHAPTER 2

Waivers

Article 11

1.   Production of the information referred to in point (a) of Article 7(1) shall be waived for specific medicinal products or for classes of medicinal products, if there is evidence showing any of the following:

| (a) | that the specific medicinal product or class of medicinal products is likely to be ineffective or unsafe in part or all of the paediatric population; |
| --- | --- |

(a)

that the specific medicinal product or class of medicinal products is likely to be ineffective or unsafe in part or all of the paediatric population;

| (b) | that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations; |
| --- | --- |

(b)

that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations;

| (c) | that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients. |
| --- | --- |

(c)

that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients.

2.   The waiver provided for in paragraph 1 may be issued with reference either to one or more specified subsets of the paediatric population, or to one or more specified therapeutic indications, or to a combination of both.

Article 12

The Paediatric Committee may of its own motion adopt an opinion, on the grounds set out in Article 11(1), to the effect that a class or a product-specific waiver, as referred to in Article 11(1), should be granted.

As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply. In the case of a class waiver, only paragraphs 6 and 7 of Article 25 shall apply.

Article 13

1.   The applicant may, on the grounds set out in Article 11(1), apply to the Agency for a product-specific waiver.

2.   Following receipt of the application, the Paediatric Committee shall appoint a rapporteur and shall within 60 days adopt an opinion as to whether or not a product-specific waiver should be granted.

Either the applicant or the Paediatric Committee may request a meeting during that 60-day period.

Whenever appropriate, the Paediatric Committee may request the applicant to supplement the particulars and documents submitted. Where the Paediatric Committee avails itself of this option, the 60-day time-limit shall be suspended until such time as the supplementary information requested has been provided.

3.   As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply.

Article 14

1.   The Agency shall maintain a list of all waivers. The list shall be regularly updated (at least every year) and made available to the public.

2.   The Paediatric Committee may, at any time, adopt an opinion advocating the review of a granted waiver.

In the case of a change affecting a product-specific waiver, the procedure laid down in Article 25 shall apply.

In the case of a change affecting a class waiver, paragraphs 6 and 7 of Article 25 shall apply.

3.   If a particular product-specific or class waiver is revoked, the requirement set out in Articles 7 and 8 shall not apply for 36 months from the date of the removal from the list of waivers.

CHAPTER 3

Paediatric investigation plan

Section 1

Requests for agreement

Article 15

1.   Where the intention is to apply for a marketing authorisation in accordance with Article 7(1)(a) or (d), Article 8 or Article 30, a paediatric investigation plan shall be drawn up and submitted to the Agency with a request for agreement.

2.   The paediatric investigation plan shall specify the timing and the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned. In addition, it shall describe any measures to adapt the formulation of the medicinal product so as to make its use more acceptable, easier, safer or more effective for different subsets of the paediatric population.

Article 16

1.   In the case of the applications referred to in Articles 7 and 8, the paediatric investigation plan shall be submitted with a request for agreement, unless otherwise justified, not later than upon completion of the human pharmaco-kinetic studies in adults specified in Section 5.2.3 of Part I of Annex I to Directive 2001/83/EC, so as to ensure that an opinion on use in the paediatric population of the medicinal product concerned can be given at the time of the assessment of the marketing authorisation or other application concerned.

2.   Within 30 days following receipt of the request referred to in paragraph 1 and in Article 15(1), the Agency shall verify the validity of the request and prepare a summary report for the Paediatric Committee.

3.   Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time-limit of 30 days shall be suspended until such time as the supplementary information requested has been provided.

Article 17

1.   Following receipt of a proposed paediatric investigation plan which is valid in accordance with the provisions of Article 15(2), the Paediatric Committee shall appoint a rapporteur and shall within 60 days adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed. When adopting its opinion, the Committee shall consider whether or not the measures proposed to adapt the formulation of the medicinal product for use in different subsets of the paediatric population are appropriate.

Within the same period, either the applicant or the Paediatric Committee may request a meeting.

2.   Within the 60-day period referred to in paragraph 1, the Paediatric Committee may request the applicant to propose modifications to the plan, in which case the time-limit referred to in paragraph 1 for the adoption of the final opinion shall be extended for a maximum of 60 days. In such cases, the applicant or the Paediatric Committee may request an additional meeting during this period. The time-limit shall be suspended until such time as the supplementary information requested has been provided.

Article 18

As soon as the Paediatric Committee adopts an opinion, whether positive or negative, the procedure laid down in Article 25 shall apply.

Article 19

If, having considered a paediatric investigation plan, the Paediatric Committee concludes that Article 11(1)(a), (b) or (c) applies to the medicinal product concerned, it shall adopt a negative opinion under Article 17(1).

In such cases, the Paediatric Committee shall adopt an opinion in favour of a waiver under Article 12, whereupon the procedure laid down in Article 25 shall apply.

Section 2

Deferrals

Article 20

1.   At the same time as the paediatric investigation plan is submitted under Article 16(1), a request may be made for deferral of the initiation or completion of some or all of the measures set out in that plan. Such deferral shall be justified on scientific and technical grounds or on grounds related to public health.

In any event, a deferral shall be granted when it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population or when studies in the paediatric population will take longer to conduct than studies in adults.

2.   On the basis of the experience acquired as a result of the operation of this Article, the Commission may adopt provisions in accordance with the procedure referred to in Article 51(2) to define further the grounds for granting a deferral.

Article 21

1.   At the same time as the Paediatric Committee adopts a positive opinion under Article 17(1), it shall, of its own motion or following a request submitted by the applicant under Article 20, adopt an opinion, if the conditions specified in Article 20 are met, in favour of deferring the initiation or completion of some or all of the measures in the paediatric investigation plan.

An opinion in favour of a deferral shall specify the time-limits for initiating or completing the measures concerned.

2.   As soon as the Paediatric Committee adopts an opinion in favour of deferral, as referred to in paragraph 1, the procedure laid down in Article 25 shall apply.

Section 3

Modification of a paediatric investigation plan

Article 22

If, following the decision agreeing the paediatric investigation plan, the applicant encounters such difficulties with its implementation as to render the plan unworkable or no longer appropriate, the applicant may propose changes or request a deferral or a waiver, based on detailed grounds, to the Paediatric Committee. Within 60 days, the Paediatric Committee shall review these changes or the request for a deferral or a waiver and adopt an opinion proposing their refusal or acceptance. As soon as the Paediatric Committee adopts an opinion, whether positive or negative, the procedure laid down in Article 25 shall apply.

Section 4

Compliance with the paediatric investigation plan

Article 23

1.   The competent authority responsible for granting marketing authorisation shall verify whether an application for marketing authorisation or variation complies with the requirements laid down in Articles 7 and 8 and whether an application submitted pursuant to Article 30 complies with the agreed paediatric investigation plan.

Where the application is submitted in accordance with the procedure set out in Articles 27 to 39 of Directive 2001/83/EC, the verification of compliance, including, as appropriate, requesting an opinion of the Paediatric Committee in accordance with paragraph 2(b) and (c), shall be conducted by the reference Member State.

2.   The Paediatric Committee may, in the following cases, be requested to give its opinion as to whether studies conducted by the applicant are in compliance with the agreed paediatric investigation plan:

| (a) | by the applicant, prior to submitting an application for marketing authorisation or variation as referred to in Articles 7, 8 and 30, respectively; |
| --- | --- |

(a)

by the applicant, prior to submitting an application for marketing authorisation or variation as referred to in Articles 7, 8 and 30, respectively;

| (b) | by the Agency, or the national competent authority, when validating an application, as referred to in point (a), which does not include an opinion concerning compliance adopted following a request under point (a); |
| --- | --- |

(b)

by the Agency, or the national competent authority, when validating an application, as referred to in point (a), which does not include an opinion concerning compliance adopted following a request under point (a);

| (c) | by the Committee for Medicinal Products for Human Use, or the national competent authority, when assessing an application, as referred to in point (a), where there is doubt concerning compliance and an opinion has not been already given following a request under points (a) or (b). |
| --- | --- |

(c)

by the Committee for Medicinal Products for Human Use, or the national competent authority, when assessing an application, as referred to in point (a), where there is doubt concerning compliance and an opinion has not been already given following a request under points (a) or (b).

In the case of point (a), the applicant shall not submit its application until the Paediatric Committee has adopted its opinion, and a copy thereof shall be annexed to the application.

3.   If the Paediatric Committee is requested to give an opinion under paragraph 2, it shall do so within 60 days of receiving the request.

Member States shall take account of such an opinion.

Article 24

If, when conducting the scientific assessment of a valid application for Marketing Authorisation, the competent authority concludes that the studies are not in conformity with the agreed paediatric investigation plan, the product shall not be eligible for the rewards and incentives provided for in Articles 36, 37 and 38.

CHAPTER 4

Procedure

Article 25

1.   Within ten days of its receipt, the Agency shall transmit the opinion of the Paediatric Committee to the applicant.

2.   Within 30 days following receipt of the opinion of the Paediatric Committee, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination of the opinion.

3.   Within 30 days following receipt of a request for re-examination pursuant to paragraph 2, the Paediatric Committee, having appointed a new rapporteur, shall issue a new opinion confirming or revising its previous opinion. The opinion shall be duly reasoned and a statement of reasons for the conclusion reached shall be annexed to the new opinion, which shall become definitive.

4.   If, within the 30-day period referred to in paragraph 2, the applicant does not request re-examination, the opinion of the Paediatric Committee shall become definitive.

5.   The Agency shall adopt a decision within a period not exceeding 10 days following receipt of the Paediatric Committee's definitive opinion. This decision shall be communicated to the applicant in writing and shall annex the definitive opinion of the Paediatric Committee.

6.   In the case of a class waiver as referred to in Article 12, the Agency shall adopt a decision within 10 days following receipt of the opinion of the Paediatric Committee as referred to in Article 13(3). This decision shall annex the opinion of the Paediatric Committee.

7.   Decisions of the Agency shall be made public after deletion of any information of a commercially confidential nature.

CHAPTER 5

Miscellaneous provisions

Article 26

Any legal or natural person developing a medicinal product intended for paediatric use may, prior to the submission of a paediatric investigation plan and during its implementation, request advice from the Agency on the design and conduct of the various tests and studies necessary to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population in accordance with Article 57(1)(n) of Regulation (EC) No 726/2004.

In addition, this legal or natural person may request advice on the design and conduct of pharmacovigilance and risk management systems as referred to in Article 34.

The Agency shall provide advice under this Article free of charge.

TITLE III

MARKETING AUTHORISATION PROCEDURES

Article 27

Save where otherwise provided in this Title, marketing authorisation procedures for the marketing authorisations covered by this Title shall be governed by the provisions laid down in Regulation (EC) No 726/2004 or in Directive 2001/83/EC.

CHAPTER 1

Marketing authorisation procedures for applications falling within the scope of Articles 7 and 8

Article 28

1.   Applications may be submitted in accordance with the procedure laid down in Articles 5 to 15 of Regulation (EC) No 726/2004 for a marketing authorisation as referred to in Article 7(1) of this Regulation which includes one or more paediatric indications on the basis of studies conducted in compliance with an agreed paediatric investigation plan.

Where authorisation is granted, the results of all those studies shall be included in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product, provided that the competent authority deems the information to be of use to patients, whether or not all the paediatric indications concerned were approved by the competent authority.

2.   Where a marketing authorisation is granted or varied, any waiver or deferral which has been granted pursuant to this Regulation shall be recorded in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

3.   If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan. For the purpose of the application of Article 45(3), this statement shall also indicate whether significant studies contained in the agreed Paediatric Investigation Plan have been completed after the entry into force of this Regulation.

Article 29

In the case of medicinal products authorised under Directive 2001/83/EC, an application as referred to in Article 8 of this Regulation may be submitted, in accordance with the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83/EC, for authorisation of a new indication, including the extension of an authorisation for use in the paediatric population, a new pharmaceutical form or a new route of administration.

That application shall comply with the requirement laid down in point (a) of Article 7(1).

The procedure shall be limited to the assessment of the specific sections of the summary of product characteristics to be varied.

CHAPTER 2

Paediatric use marketing authorisation

Article 30

1.   Submission of an application for a paediatric use marketing authorisation shall in no way preclude the right to apply for a marketing authorisation for other indications.

2.   An application for a paediatric use marketing authorisation shall be accompanied by the particulars and documents necessary to establish quality, safety and efficacy in the paediatric population, including any specific data needed to support an appropriate strength, pharmaceutical form or route of administration for the product, in accordance with an agreed paediatric investigation plan.

The application shall also include the decision of the Agency agreeing the paediatric investigation plan concerned.

3.   Where a medicinal product is or has been authorised in a Member State or in the Community, data contained in the dossier on that product may, where appropriate, be referred to, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or Article 10 of Directive 2001/83/EC, in an application for a paediatric use marketing authorisation.

4.   The medicinal product in respect of which a paediatric use marketing authorisation is granted may retain the name of any medicinal product which contains the same active substance and in respect of which the same holder has been granted authorisation for use in adults.

Article 31

Without prejudice to Article 3(2) of Regulation (EC) No 726/2004, an application for a paediatric use marketing authorisation may be made in accordance with the procedure laid down in Articles 5 to 15 of Regulation (EC) No 726/2004.

CHAPTER 3

Identification

Article 32

1.   Where a medicinal product is granted a marketing authorisation for a paediatric indication, the label shall display the symbol agreed in accordance with paragraph 2. The package leaflet shall contain an explanation of the meaning of the symbol.

2.   By ... (10), the Commission shall select a symbol following a recommendation of the Paediatric Committee. The Commission shall make the symbol public.

3.   The provisions of this Article shall also apply to medicinal products authorised before the entry into force of this Regulation, and to medicinal products authorised after the entry into force of this Regulation but before the symbol has been made public, if they are authorised for paediatric indications.

In this case, the symbol and the explanation referred to in paragraph 1 shall be included in the labelling and package leaflet respectively of the medicinal products concerned not later than two years after the symbol has been made public.

TITLE IV

POST-AUTHORISATION REQUIREMENTS

Article 33

Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those products have already been marketed with other indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the product on the market taking into account the paediatric indication. A register, coordinated by the Agency, and made publicly available, shall mention these deadlines.

Article 34

1.   In the following cases, the applicant shall detail, in addition to the normal requirements for post-marketing monitoring, the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product:

| (a) | applications for a marketing authorisation that includes a paediatric indication; |
| --- | --- |

(a)

applications for a marketing authorisation that includes a paediatric indication;

| (b) | applications to include a paediatric indication in an existing marketing authorisation; |
| --- | --- |

(b)

applications to include a paediatric indication in an existing marketing authorisation;

| (c) | applications for a paediatric use marketing authorisation. |
| --- | --- |

(c)

applications for a paediatric use marketing authorisation.

2.   Where there is particular cause for concern, the competent authority may require, as a condition for granting marketing authorisation, that a risk management system be set up or that specific post-marketing studies be performed and submitted for review. A risk management system shall comprise a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions.

Assessment of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 104(6) of Directive 2001/83/EC and Article 24(3) of Regulation (EC) No 726/2004.

In addition, the competent authority may request submission of additional reports assessing the effectiveness of any risk minimisation system and the results of any such studies performed.

3.   In the case of a deferral, the marketing authorisation holder shall submit an annual report to the Agency providing an update on progress with paediatric studies in accordance with the decision of the Agency agreeing the paediatric investigation plan and granting a deferral.

The Agency shall inform the competent authority if it is found that the marketing authorisation holder has failed to comply with the decision of the Agency agreeing the paediatric investigation plan and granting a deferral.

4.   The Agency shall draw up guidelines relating to the application of this Article.

Article 35

If a medicinal product is authorised for a paediatric indication and the marketing authorisation holder has benefited from rewards or incentives under Article 36, 37 or 38, and these periods of protection have expired, and if the marketing authorisation holder intends to discontinue placing the medicinal product on the market, the marketing authorisation holder shall transfer the marketing authorisation or allow a third party, which has declared its intention to continue to place the medicinal product in question on the market, to use the pharmaceutical, pre-clinical and clinical documentation contained in the file of the medicinal product on the basis of Article 10c of Directive 2001/83/EC.

The marketing authorisation holder shall inform the Agency of its intention to discontinue the placing on the market of the product no less than six months before the discontinuation. The Agency shall make this fact public.

TITLE V

REWARDS AND INCENTIVES

Article 36

1.   Where an application under Article 7 or 8 includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Articles 13(1) and 13(2) of Regulation (EEC) No 1768/92.

The first subparagraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

2.   The inclusion in a marketing authorisation of the statement referred to in Article 28(3) shall be used for the purposes of applying paragraph 1 of this Article.

3.   Where the procedures laid down in Directive 2001/83/EC have been used, the six-month extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.

4.   Paragraphs 1, 2 and 3 shall apply to products that are protected by a supplementary protection certificate under Regulation (EEC) No 1768/92, or under a patent which qualifies for the granting of the supplementary protection certificate. They shall not apply to medicinal products designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.

5.   In the case of an application under Article 8 which leads to the authorisation of a new paediatric indication, paragraphs 1, 2 and 3 shall not apply if the applicant applies for, and obtains, a one-year extension of the period of marketing protection for the medicinal product concerned, on the grounds that this new paediatric indication brings a significant clinical benefit in comparison with existing therapies, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or the fourth subparagraph of Article 10(1) of Directive 2001/83/EC.

Article 37

Where an application for a marketing authorisation is submitted in respect of a medicinal product designated as an orphan medicinal product pursuant to Regulation (EC) No 141/2000 and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, and the statement referred to in Article 28(3) of this Regulation is subsequently included in the marketing authorisation granted, the 10-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to 12 years.

The first paragraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

Article 38

1.   Where a paediatric use marketing authorisation is granted in accordance with Articles 5 to 15 of Regulation (EC) No 726/2004, the data and marketing protection periods referred to in Article 14(11) of that Regulation shall apply.

2.   Where a paediatric use marketing authorisation is granted in accordance with the procedures laid down in Directive 2001/83/EC, the data and marketing protection periods referred to in Article 10(1) of that Directive shall apply.

Article 39

1.   In addition to the rewards and incentives provided for in Articles 36, 37 and 38, medicinal products for paediatric use may be eligible for incentives provided by the Community or by the Member States to support research into, and the development and availability of, medicinal products for paediatric use.

2.   By ... (11), the Member States shall communicate to the Commission detailed information concerning any measures they have enacted to support research into, and the development and availability of, medicinal products for paediatric use. This information shall be updated regularly at the request of the Commission.

3.   By ... (12), the Commission shall make publicly available a detailed inventory of all rewards and incentives provided by the Community and Member States to support research into, and the development and availability of, medicinal products for paediatric use. This inventory shall be updated regularly and the updates shall also be made publicly available.

Article 40

1.   Funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate.

2.   This Community funding shall be delivered through the Community Framework Programmes for Research, Technological Development and Demonstration Activities or any other Community initiatives for the funding of research.

TITLE VI

COMMUNICATION AND COORDINATION

Article 41

1.   The European database created by Article 11 of Directive 2001/20/EC shall include clinical trials carried out in third countries which are contained in an agreed paediatric investigation plan, in addition to the clinical trials referred to in Articles 1 and 2 of that Directive. In the case of such clinical trials carried out in third countries, the details listed in Article 11 of that Directive shall be entered into the database by the addressee of the Agency's decision on a paediatric investigation plan.

By way of derogation from the provisions of Article 11 of Directive 2001/20/EC, the Agency shall make public part of the information on paediatric clinical trials entered in the European database.

2.   Details of the results of all the trials referred to in paragraph 1 and of any other trials submitted to competent authorities in compliance with Articles 45 and 46 shall be made public by the Agency, whether or not the trial was terminated prematurely. These results shall be submitted without delay to the Agency by the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan, or by the marketing authorisation holder as appropriate.

3.   In consultation with the Agency, Member States and interested parties, the Commission shall draw up guidance on the nature of the information referred to in paragraph 1 to be entered in the European database created by Article 11 of Directive 2001/20/EC, on which information shall be made accessible to the public in application of paragraph 1, on how clinical trial results shall be submitted and be made public in application of paragraph 2, and on the Agency's responsibilities and tasks in this regard.

Article 42

Member States shall collect available data on all existing uses of medicinal products in the paediatric population and shall communicate these data to the Agency by ... (13).

The Paediatric Committee shall provide guidance on the content and the format of the data to be collected by ... (14).

Article 43

1.   On the basis of the information referred to in Article 42 and after consulting the Commission, the Member States and the interested parties, the Paediatric Committee shall establish an inventory of therapeutic needs, in particular with a view to identifying research priorities.

By ... (15), the Agency shall make the inventory public and shall update it regularly.

2.   In establishing the inventory of therapeutic needs, account shall be taken of the prevalence of the conditions in the paediatric population, the seriousness of the conditions to be treated, the availability and suitability of alternative treatments for the conditions in the paediatric population, including the efficacy and the adverse reaction profile of those treatments, including any unique paediatric safety issues, and any data resulting from studies in third countries.

Article 44

1.   The Agency shall, with the scientific support of the Paediatric Committee, develop a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population.

2.   The objectives of the European network shall be, inter alia, to coordinate studies relating to paediatric medicinal products, to build up the necessary scientific and administrative competences at European level, and to avoid unnecessary duplication of studies and testing in the paediatric population.

3.   By ... (16), the Management Board of the Agency shall, on a proposal from the Executive Director and following consultation with the Commission, the Member States and interested parties, adopt an implementing strategy for the launching and operation of the European network. This network must, where appropriate, be compatible with the work of strengthening the foundations of the European Research Area in the context of the Community Framework Programmes for Research, Technological Development and Demonstration Activities.

Article 45

1.   By ... (16), any paediatric studies already completed, by the date of entry into force, in respect of products authorised in the Community shall be submitted by the marketing authorisation holder for assessment to the competent authority.

The competent authority may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly. Competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned.

The Agency shall coordinate the exchange of information.

2.   All existing paediatric studies, as referred to in paragraph 1, and all paediatric studies initiated prior to the entry into force of this Regulation shall be eligible to be included in a paediatric investigation plan, and shall be taken into consideration by the Paediatric Committee when assessing applications for paediatric investigation plans, waivers and deferrals and by competent authorities when assessing applications submitted pursuant to Article 7, 8 or 30.

3.   Without prejudice to the previous paragraph, the rewards and incentives of Articles 36, 37 and 38 shall only be granted provided that significant studies contained in an agreed Paediatric Investigation Plan are completed after the entry into force of this Regulation.

Article 46

1.   Any other marketing authorisation holder-sponsored studies which involve the use in the paediatric population of a medicinal product covered by a marketing authorisation, whether or not they are conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the competent authority within six months of completion of the studies concerned.

2.   Paragraph 1 shall apply independent of whether or not the marketing authorisation holder intends to apply for a marketing authorisation of a paediatric indication.

3.   The competent authority may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly.

4.   Competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned.

5.   The Agency shall coordinate the exchange of information.

TITLE VII

GENERAL AND FINAL PROVISIONS

CHAPTER 1

General provisions

Section 1

Fees, Community funding, penalties and reports

Article 47

1.   Where an application for a paediatric use marketing authorisation is submitted in accordance with the procedure laid down in Regulation (EC) No 726/2004, the amount of the reduced fees for the examination of the application and the maintenance of the marketing authorisation shall be fixed in accordance with Article 70 of Regulation (EC) No 726/2004.

2.   Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (17) shall apply.

3.   Assessments of the following by the Paediatric Committee shall be free of charge:

| (a) | applications for waiver; |
| --- | --- |

(a)

applications for waiver;

| (b) | applications for deferral; |
| --- | --- |

(b)

applications for deferral;

| (c) | paediatric investigation plans; |
| --- | --- |

(c)

paediatric investigation plans;

| (d) | compliance with the agreed paediatric investigation plan. |
| --- | --- |

(d)

compliance with the agreed paediatric investigation plan.

Article 48

The Community contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover the work of the Paediatric Committee, including scientific support provided by experts, and of the Agency, including the assessment of paediatric investigation plans, scientific advice and any fee waivers provided for in this Regulation, and shall support the Agency's activities under Articles 41 and 44 of this Regulation.

Article 49

1.   Without prejudice to the Protocol on the Privileges and Immunities of the European Communities, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedures laid down in Directive 2001/83/EC and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive.

Member States shall inform the Commission of these provisions by ... (18). They shall notify any subsequent alterations as soon as possible.

2.   Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.

3.   At the Agency's request, the Commission may impose financial penalties for infringement of the provisions of this Regulation or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedure laid down in Regulation (EC) No 726/2004. The maximum amounts as well as the conditions and methods for collection of these penalties shall be laid down in accordance with the procedure referred to in Article 51(2) of this Regulation.

4.   The Commission shall make public the names of anyone infringing the provisions of this Regulation or of any implementing measures adopted pursuant to it and the amounts of, and reasons for, the financial penalties imposed.

Article 50

1.   On the basis of a report from the Agency, and at least on an annual basis, the Commission shall make public a list of the companies and of the products that have benefited from any of the rewards and incentives in this Regulation and the companies that have failed to comply with any of the obligations in this Regulation. The Member States shall provide this information to the Agency.

2.   By ... (19), the Commission shall present to the European Parliament and the Council a general report on experience acquired as a result of the application of this Regulation. This shall include in particular a detailed inventory of all medicinal products authorised for paediatric use since its entry into force.

3.   By... (20), the Commission shall present a report to the European Parliament and the Council on the experience acquired as a result of the application of Articles 36, 37 and 38. The report shall include an analysis of the economic impact of the rewards and incentives, together with an analysis of the estimated consequences for public health of this Regulation, with a view to proposing any necessary amendments.

4.   Provided that there are sufficient data available to allow robust analyses to be made, the provisions of paragraph 3 shall be fulfilled at the same time as the provisions of paragraph 2.

Section 2

Standing Committee

Article 51

1.   The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121 of Directive 2001/83/EC, hereinafter referred to as ’the Committee’.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   The Committee shall adopt its rules of procedure.

CHAPTER 2

Amendments

Article 52

Regulation (EEC) No 1768/92 is hereby amended as follows:

| 1. | in Article 1, the following definition shall be added:






  ‘(e) | “Application for an extension of the duration” means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and of Article 36 of Regulation (EC) No .../2006 of the European Parliament and of the Council, of ..., on medicinal products for paediatric use (21); |
| --- | --- | --- |

1.

in Article 1, the following definition shall be added:

‘(e)

“Application for an extension of the duration” means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and of Article 36 of Regulation (EC) No .../2006 of the European Parliament and of the Council, of ..., on medicinal products for paediatric use (21);

| 2. | in Article 7, the following paragraphs shall be added:
  ‘3.   The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Articles 8(1)(d) or 8(1a), respectively, are fulfilled.
  4.   The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.’; |
| --- | --- |

2.

in Article 7, the following paragraphs shall be added:

‘3.   The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Articles 8(1)(d) or 8(1a), respectively, are fulfilled.

4.   The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.’;

| 3. | Article 8 shall be amended as follows:






  (a) | in paragraph 1, the following point shall be added:






  ‘(d) | where the application for a certificate includes a request for an extension of the duration:






  (i) | a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No .../2006; |
| --- | --- | --- | --- | --- |

3.

Article 8 shall be amended as follows:

(a)

in paragraph 1, the following point shall be added:

‘(d)

where the application for a certificate includes a request for an extension of the duration:

(i)

a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No .../2006;

| (ii) | where necessary, in addition to the copy of the authorisations to place the product on the market as referred to in point (b), proof that it has authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No .../2006.’; |
| --- | --- |

(ii)

where necessary, in addition to the copy of the authorisations to place the product on the market as referred to in point (b), proof that it has authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No .../2006.’;

| (b) | the following paragraphs shall be inserted:






  ‘1a. | Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) and a reference to the application for a certificate already filed. |
| --- | --- | --- |

(b)

the following paragraphs shall be inserted:

‘1a.

Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) and a reference to the application for a certificate already filed.

| 1b. | The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.’; |
| --- | --- |

1b.

The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.’;

| (c) | paragraph 2 shall be replaced by the following:
  ‘2.   Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.’; |
| --- | --- |

(c)

paragraph 2 shall be replaced by the following:

‘2.   Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.’;

| 4. | Article 9 shall be amended as follows:






  (a) | in paragraph 1, the following subparagraph shall be added:
  ‘The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.’; |
| --- | --- | --- |

4.

Article 9 shall be amended as follows:

(a)

in paragraph 1, the following subparagraph shall be added:

‘The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.’;

| (b) | in paragraph 2, the following point shall be added:






  ‘(f) | where applicable, an indication that the application includes an application for an extension of the duration.’; |
| --- | --- | --- |

(b)

in paragraph 2, the following point shall be added:

‘(f)

where applicable, an indication that the application includes an application for an extension of the duration.’;

| (c) | the following paragraph shall be added:
  ‘3.   Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate.’; |
| --- | --- |

(c)

the following paragraph shall be added:

‘3.   Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate.’;

| 5. | in Article 10, the following paragraph shall be added:
  ‘6.   Paragraphs 1 to 4 shall apply, mutatis mutandis, to the application for an extension of the duration.’; |
| --- | --- |

5.

in Article 10, the following paragraph shall be added:

‘6.   Paragraphs 1 to 4 shall apply, mutatis mutandis, to the application for an extension of the duration.’;

| 6. | in Article 11, the following paragraph shall be added:
  ‘3.   Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.’; |
| --- | --- |

6.

in Article 11, the following paragraph shall be added:

‘3.   Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.’;

| 7. | in Article 13, the following paragraph shall be added:
  ‘3.   The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No .../2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.’; |
| --- | --- |

7.

in Article 13, the following paragraph shall be added:

‘3.   The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No .../2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.’;

| 8. | the following Article shall be inserted:
  ‘Article 15a
  Revocation of an extension of the duration
  1.   The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No .../....
  2.   Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.’; |
| --- | --- |

8.

the following Article shall be inserted:

‘Article 15a

Revocation of an extension of the duration

1.   The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No .../....

2.   Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.’;

| 9. | Article 16 shall be amended as follows:






  (a) | the text of Article 16 becomes paragraph 1; |
| --- | --- | --- |

9.

Article 16 shall be amended as follows:

(a)

the text of Article 16 becomes paragraph 1;

| (b) | the following paragraph shall be added:
  ‘2.   If the extension of the duration is revoked in accordance with Article 15a, notification thereof shall be published by the authority referred to in Article 9(1).’; |
| --- | --- |

(b)

the following paragraph shall be added:

‘2.   If the extension of the duration is revoked in accordance with Article 15a, notification thereof shall be published by the authority referred to in Article 9(1).’;

| 10. | Article 17 shall be replaced by the following:
  ‘Article 17
  Appeals
  The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 15a(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.’ |
| --- | --- |

10.

Article 17 shall be replaced by the following:

‘Article 17

Appeals

The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 15a(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.’

Article 53

In Article 11 of Directive 2001/20/EC, the following paragraph shall be added:

‘4.   By way of derogation from paragraph 1, the Agency shall make public part of the information on paediatric clinical trials entered in the European database in accordance with the provisions of Regulation (EC) No .../2006 of the European Parliament and of the Council, of ... on medicinal products for paediatric use (22).

Article 54

In Article 6 of Directive 2001/83/EC, the first subparagraph of paragraph 1 shall be replaced by the following:

‘1.   No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or unless an authorisation has been granted in accordance with Regulation (EC) No. 726/2004, read in conjunction with Regulation (EC) No .../2006 (22).

Article 55

Regulation (EC) No 726/2004 is hereby amended as follows:

| 1. | Article 56(1) shall be replaced by the following:
  ‘1.   The Agency shall comprise:






  (a) | the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use; |
| --- | --- | --- |

1.

Article 56(1) shall be replaced by the following:

‘1.   The Agency shall comprise:

(a)

the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use;

| (b) | the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use; |
| --- | --- |

(b)

the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use;

| (c) | the Committee on Orphan Medicinal Products; |
| --- | --- |

(c)

the Committee on Orphan Medicinal Products;

| (d) | the Committee on Herbal Medicinal Products; |
| --- | --- |

(d)

the Committee on Herbal Medicinal Products;

| (e) | the Paediatric Committee; |
| --- | --- |

(e)

the Paediatric Committee;

| (f) | a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them; |
| --- | --- |

(f)

a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them;

| (g) | an Executive Director, who shall exercise the responsibilities set out in Article 64; |
| --- | --- |

(g)

an Executive Director, who shall exercise the responsibilities set out in Article 64;

| (h) | a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.’; |
| --- | --- |

(h)

a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.’;

| 2. | in Article 57(1), the following point shall be added:






  ‘(t) | taking decisions as referred to in Article 7(1) of Regulation (EC) No .../2006 of the European Parliament and of the Council, of ..., on medicinal products for paediatric use (23). |
| --- | --- | --- |

2.

in Article 57(1), the following point shall be added:

‘(t)

taking decisions as referred to in Article 7(1) of Regulation (EC) No .../2006 of the European Parliament and of the Council, of ..., on medicinal products for paediatric use (23).

23

| 3. | the following Article shall be inserted:
  ‘Article 73a
  Decisions taken by the Agency under Regulation (EC) No .../2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.’. |
| --- | --- |

3.

the following Article shall be inserted:

‘Article 73a

Decisions taken by the Agency under Regulation (EC) No .../2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.’.

CHAPTER 3

Final provisions

Article 56

The requirement laid down in Article 7(1) shall not apply to valid applications pending at the time of entry into force of this Regulation.

Article 57

1.   This Regulation shall enter into force on the 30th day following its publication in the Official Journal of the European Union.

Official Journal of the European Union.

2.   Article 7 shall apply from ... (24).

24

Article 8 shall apply from ... (25).

25

Articles 30 and 31 shall apply from ... (26).

26

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, ...

For the European Parliament

The President

...

For the Council

The President

...

---

(1)  Opinion delivered on 11 May 2005 (OJ C 267, 27.10.2005, p. 1).

1

(2)  European Parliament Opinion of 7 September 2005 (not yet published in the Official Journal), Council Common Position of 10 March 2006 and European Parliament Position (not yet published in the Official Journal).

2

(3)  OJ L 121, 1.5.2001, p. 34.

3

(4)  OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

4

(5)  OJ L 136, 30.4.2004, p. 1.

5

(6)  OJ L 182, 2.7.1992, p. 1. Regulation as last amended by the 2003 Act of Accession.

6

(7)  OJ L 18, 22.1.2000, p. 1.

7

(8)  OJ L 184, 17.7.1999, p. 23.

8

(9)  Six months from the entry into force of this Regulation.

9

(10)  One year from the entry into force of this Regulation.

10

(11)  One year from the entry into force of this Regulation.

11

(12)  18 months from the entry into force of this Regulation.

12

(13)  Two years from the entry into force of this Regulation.

13

(14)  Nine months from the entry into force of this Regulation.

14

(15)  Three years from the entry into force of this Regulation.

15

(16)  One year from the date of entry into force of this Regulation.

16

(17)  OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).

17

.

(18)  Nine months from the date of entry into force of this Regulation.

18

(19)  Six years from the date of entry into force of this Regulation.

19

(20)  Ten years from the date of entry into force of this Regulation.

20

(21)  OJ L ..., ..., p. ...’;

21

(22)  OJ L ..., ..., p. ...’;

22

(23)  OJ L ..., ..., p. ...’;

23

(24)  18 months following the date of entry into force of this Regulation.

24

(25)  24 months following the date of entry into force of this Regulation.

25

(26)  Six months following the date of entry into force of this Regulation.

26

---

STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

| 1. | On 29 September 2004 the Commission adopted a proposal for a Regulation of the European Parliament and of the Council on Medicinal Products for Paediatric Use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 (1). |
| --- | --- |

1.

On 29 September 2004 the Commission adopted a proposal for a Regulation of the European Parliament and of the Council on Medicinal Products for Paediatric Use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 (1).

| 2. | The Economic and Social Committee adopted its opinion at its 417th plenary session on 11 and 12 May 2005 (2). |
| --- | --- |

2.

The Economic and Social Committee adopted its opinion at its 417th plenary session on 11 and 12 May 2005 (2).

| 3. | The European Parliament adopted its first-reading opinion on 7 September 2005 (3). |
| --- | --- |

3.

The European Parliament adopted its first-reading opinion on 7 September 2005 (3).

| 4. | The Commission adopted an amended proposal on 10 November 2005 (4). |
| --- | --- |

4.

The Commission adopted an amended proposal on 10 November 2005 (4).

| 5. | On 9 December 2005, the Council reached a political agreement with a view to adopting a common position in accordance with Article 251 of the Treaty. |
| --- | --- |

5.

On 9 December 2005, the Council reached a political agreement with a view to adopting a common position in accordance with Article 251 of the Treaty.

| 6. | On 10 March 2006, the Council adopted its common position on the proposal as set out in doc. 15763/05. |
| --- | --- |

6.

On 10 March 2006, the Council adopted its common position on the proposal as set out in doc. 15763/05.

II.   OBJECTIVES

| 7. | The general objectives of the Commission proposal are to:






  — | increase the development of medicines for use in children, |
| --- | --- | --- |

7.

The general objectives of the Commission proposal are to:

—

increase the development of medicines for use in children,

| — | ensure that medicines used to treat children are subject to high quality research, |
| --- | --- |

—

ensure that medicines used to treat children are subject to high quality research,

| — | ensure that medicines used to treat children are appropriately authorised for use in children, |
| --- | --- |

—

ensure that medicines used to treat children are appropriately authorised for use in children,

| — | improve the information available on the use of medicines in children, |
| --- | --- |

—

improve the information available on the use of medicines in children,

| — | achieve these objectives without subjecting children to unnecessary clinical trials and in full compliance with Directive 2001/20/EC (the Clinical Trials Directive) (5). |
| --- | --- |

—

achieve these objectives without subjecting children to unnecessary clinical trials and in full compliance with Directive 2001/20/EC (the Clinical Trials Directive) (5).

III.   COMMON POSITION

General

| 8. | The Council, which agrees with the objectives of the proposal, has nevertheless endeavoured to improve some of the provisions and to add further features, notably as regards research into paediatric use of off-patent medicines (Article 40), safeguarding measures aiming at keeping paediatric products on the market (Article 35) and as concerns transparency (Articles 25 and 41). During the detailed reading of the proposal (November 2004 to November 2005) a number of drafting changes have been introduced to clarify the text, address legal/linguistic issues and to ensure the overall coherence of the Regulation. Amendments that are of a pure legal/linguistic nature are normally not mentioned below. |
| --- | --- |

8.

The Council, which agrees with the objectives of the proposal, has nevertheless endeavoured to improve some of the provisions and to add further features, notably as regards research into paediatric use of off-patent medicines (Article 40), safeguarding measures aiming at keeping paediatric products on the market (Article 35) and as concerns transparency (Articles 25 and 41). During the detailed reading of the proposal (November 2004 to November 2005) a number of drafting changes have been introduced to clarify the text, address legal/linguistic issues and to ensure the overall coherence of the Regulation. Amendments that are of a pure legal/linguistic nature are normally not mentioned below.

| 9. | In its Plenary vote on 7 September 2005, the European Parliament adopted 69 amendments to the proposal.






  (a) | 42 of these have been incorporated, either in full, in part or in principle into the Council's common position corresponding to around two thirds of the proposed amendments, |
| --- | --- | --- |

9.

In its Plenary vote on 7 September 2005, the European Parliament adopted 69 amendments to the proposal.

(a)

42 of these have been incorporated, either in full, in part or in principle into the Council's common position corresponding to around two thirds of the proposed amendments,

| (b) | 27 amendments have not been accepted. |
| --- | --- |

(b)

27 amendments have not been accepted.

| 10. | When preparing its common position, the Council examined closely the Commission's amended proposal. With the exception of redrafts (notably to Articles 32 and 49) the common position incorporates most of the amendments proposed by the European Parliament accepted or accepted in principle by the Commission in its amended proposal. |
| --- | --- |

10.

When preparing its common position, the Council examined closely the Commission's amended proposal. With the exception of redrafts (notably to Articles 32 and 49) the common position incorporates most of the amendments proposed by the European Parliament accepted or accepted in principle by the Commission in its amended proposal.

| 11. | In the legal-linguistic finalisation of the text of the common position certain recitals and articles have been renumbered. This document follows the numbering used in the common position and therefore the numbering sometimes differs from that of the texts of the Parliament's Opinion and the amended proposal. |
| --- | --- |

11.

In the legal-linguistic finalisation of the text of the common position certain recitals and articles have been renumbered. This document follows the numbering used in the common position and therefore the numbering sometimes differs from that of the texts of the Parliament's Opinion and the amended proposal.

Recitals

| 12. | In recital 3, the European Parliament proposed additional wording on types of formulation and the route of administration (Amendment 1), which has been accepted with minor redrafting to improve clarity. |
| --- | --- |

12.

In recital 3, the European Parliament proposed additional wording on types of formulation and the route of administration (Amendment 1), which has been accepted with minor redrafting to improve clarity.

| 13. | The European Parliament also proposed some clarifications to recital 4 (Amendment 2), Recital (5) (Amendment 4) and Recital (7) (Amendment 5), which were all included in the Common Position, although the words ‘where indicated’ in recital 4 were considered to be redundant and were not included. |
| --- | --- |

13.

The European Parliament also proposed some clarifications to recital 4 (Amendment 2), Recital (5) (Amendment 4) and Recital (7) (Amendment 5), which were all included in the Common Position, although the words ‘where indicated’ in recital 4 were considered to be redundant and were not included.

| 14. | The European Parliament proposed to insert a new recital 4a concerning an inventory of paediatric medicinal products (Amendment 3), which the Council decided not to include, since it prefers the structure of the Commission proposal. The provision regarding the inventory should remain in Article 42 in Title VI (communication and coordination). |
| --- | --- |

14.

The European Parliament proposed to insert a new recital 4a concerning an inventory of paediatric medicinal products (Amendment 3), which the Council decided not to include, since it prefers the structure of the Commission proposal. The provision regarding the inventory should remain in Article 42 in Title VI (communication and coordination).

| 15. | As concerns recital 8 on the Paediatric Committee, the first and third parts of Amendment 6 were accepted with minor redrafting, although the Council did not consider the Paediatric Committee to be primarily responsible for the ethical assessment of the Paediatric Investigation Plan. Ethical assessment of proposals for clinical trials is the primary responsibility of the Ethics Committees. The Council does not support the second part of the amendment as it does not consider that members of the Paediatric Committee must have international-level experience and knowledge of the pharmaceutical industry. |
| --- | --- |

15.

As concerns recital 8 on the Paediatric Committee, the first and third parts of Amendment 6 were accepted with minor redrafting, although the Council did not consider the Paediatric Committee to be primarily responsible for the ethical assessment of the Paediatric Investigation Plan. Ethical assessment of proposals for clinical trials is the primary responsibility of the Ethics Committees. The Council does not support the second part of the amendment as it does not consider that members of the Paediatric Committee must have international-level experience and knowledge of the pharmaceutical industry.

| 16. | In recital 10 the Council agrees with part of Amendment 7. As for the second part of this Amendment, the Council has deemed it more appropriate to clarify that the reason for the legal provisions in Article 16(1) is to ensure an early dialogue between the physical or legal person developing a new medicinal product and the Paediatric Committee. |
| --- | --- |

16.

In recital 10 the Council agrees with part of Amendment 7. As for the second part of this Amendment, the Council has deemed it more appropriate to clarify that the reason for the legal provisions in Article 16(1) is to ensure an early dialogue between the physical or legal person developing a new medicinal product and the Paediatric Committee.

| 17. | In recital 11 the Council agreed in principle to Amendment 8, but made a minor redrafting, pointing to the use of waivers and deferrals, in order to maintain coherence within the Regulation. |
| --- | --- |

17.

In recital 11 the Council agreed in principle to Amendment 8, but made a minor redrafting, pointing to the use of waivers and deferrals, in order to maintain coherence within the Regulation.

| 18. | The Council shares the view of the European Parliament that research into the paediatric use of medicinal products, which are not protected by a patent or supplementary protection certificate, is important and to this aim proposes a new Article 40 as well as a new recital 12 that contains the ideas behind Amendment 9, but with minor redrafting to maintain coherence with the new article to which it refers. |
| --- | --- |

18.

The Council shares the view of the European Parliament that research into the paediatric use of medicinal products, which are not protected by a patent or supplementary protection certificate, is important and to this aim proposes a new Article 40 as well as a new recital 12 that contains the ideas behind Amendment 9, but with minor redrafting to maintain coherence with the new article to which it refers.

| 19. | Amendment 10 to recital 16 has been included in the common position. |
| --- | --- |

19.

Amendment 10 to recital 16 has been included in the common position.

| 20. | The Council has amended recital 18 to correspond to the amendments of Article 32. |
| --- | --- |

20.

The Council has amended recital 18 to correspond to the amendments of Article 32.

| 21. | The European Parliament in Amendment 11 proposed to amend recital 22. The Council, for reasons set out in relation to Article 33, cannot support this amendment. |
| --- | --- |

21.

The European Parliament in Amendment 11 proposed to amend recital 22. The Council, for reasons set out in relation to Article 33, cannot support this amendment.

| 22. | Amendment 12 proposes to introduce in recital 23 reference to ‘a European paediatric form’ aimed at facilitating Community wide marketing of paediatric medicines placed on the market only at national level. The Council cannot support this amendment since it does not correspond to any existing provisions in the Proposal or any proposed amendments to the existing provisions. |
| --- | --- |

22.

Amendment 12 proposes to introduce in recital 23 reference to ‘a European paediatric form’ aimed at facilitating Community wide marketing of paediatric medicines placed on the market only at national level. The Council cannot support this amendment since it does not correspond to any existing provisions in the Proposal or any proposed amendments to the existing provisions.

| 23. | The Council is also unable to support Amendment 13 to recital 24 since the competent authorities that grant the marketing authorisations monitor the fulfilment of the terms and conditions of the marketing authorisation and the post-authorisation obligations; this is not the responsibility of the Paediatric Committee. |
| --- | --- |

23.

The Council is also unable to support Amendment 13 to recital 24 since the competent authorities that grant the marketing authorisations monitor the fulfilment of the terms and conditions of the marketing authorisation and the post-authorisation obligations; this is not the responsibility of the Paediatric Committee.

| 24. | The common position also contains a new recital 25, which refers to the new Article 35. |
| --- | --- |

24.

The common position also contains a new recital 25, which refers to the new Article 35.

| 25. | The Council does not support Amendment 14 to recital 26, for reasons that are outlined in the text regarding Article 36 below. |
| --- | --- |

25.

The Council does not support Amendment 14 to recital 26, for reasons that are outlined in the text regarding Article 36 below.

| 26. | In order to give an explanation for certain provisions in Article 52 (amendments to the SPC Regulation), relating to the reward mechanisms foreseen under Title V, the Council inserted a new recital 27. |
| --- | --- |

26.

In order to give an explanation for certain provisions in Article 52 (amendments to the SPC Regulation), relating to the reward mechanisms foreseen under Title V, the Council inserted a new recital 27.

| 27. | As regards recital 31, the Council has decided to stress that unnecessary repetition of studies should be avoided and to include the first part of Amendment 15 proposed by the Parliament concerning a European register of paediatric clinical trials. The second and third parts of this amendment have not been accepted as the former repeats text already in place and the latter does not correspond to any existing provisions or proposed amendments of existing provisions. An additional sentence was added at the end of the paragraph to echo the amendment to Article 41 which provides that parts of the paediatric clinical trials database shall be publicly accessible. |
| --- | --- |

27.

As regards recital 31, the Council has decided to stress that unnecessary repetition of studies should be avoided and to include the first part of Amendment 15 proposed by the Parliament concerning a European register of paediatric clinical trials. The second and third parts of this amendment have not been accepted as the former repeats text already in place and the latter does not correspond to any existing provisions or proposed amendments of existing provisions. An additional sentence was added at the end of the paragraph to echo the amendment to Article 41 which provides that parts of the paediatric clinical trials database shall be publicly accessible.

| 28. | The Council supports the structure of the Commission proposal, and, consequently, holds that the provisions on the inventory of therapeutic needs should be maintained in Title VI (communication and coordination). It can therefore not support Amendment 16, which proposes that recital 32 should be deleted. |
| --- | --- |

28.

The Council supports the structure of the Commission proposal, and, consequently, holds that the provisions on the inventory of therapeutic needs should be maintained in Title VI (communication and coordination). It can therefore not support Amendment 16, which proposes that recital 32 should be deleted.

| 29. | The Council supports the proposal in Amendment 17 to stress the importance of using also data from third countries, but made some minor redrafting of this amendment to recital 33 to improve clarity. |
| --- | --- |

29.

The Council supports the proposal in Amendment 17 to stress the importance of using also data from third countries, but made some minor redrafting of this amendment to recital 33 to improve clarity.

| 30. | The Council has included a new recital 38 that explains why the proposed Regulation is in accordance with the principles of subsidiarity and proportionality required in Article 5 of the Treaty. |
| --- | --- |

30.

The Council has included a new recital 38 that explains why the proposed Regulation is in accordance with the principles of subsidiarity and proportionality required in Article 5 of the Treaty.

Title I — Introductory provisions

| 31. | Like the European Parliament, the Council considers it necessary to clarify that the paediatric population should not be subject to any kind of unnecessary trials and has therefore included the first part of amendment 18 into Article 1. However, the Council cannot support the second part of the Amendment as the Regulation applies to the entire paediatric population without exception. |
| --- | --- |

31.

Like the European Parliament, the Council considers it necessary to clarify that the paediatric population should not be subject to any kind of unnecessary trials and has therefore included the first part of amendment 18 into Article 1. However, the Council cannot support the second part of the Amendment as the Regulation applies to the entire paediatric population without exception.

| 32. | The Council considers it appropriate to move the definition of paediatric use marketing authorisation to Article 2, which contains other definitions. |
| --- | --- |

32.

The Council considers it appropriate to move the definition of paediatric use marketing authorisation to Article 2, which contains other definitions.

| 33. | The Council shares the position of the European Parliament that it is important that the Paediatric Committee be established within six months after the entry into force of the Regulation and has therefore included Amendment 20 in the first subparagraph of Article 3(1), together with a redrafting to ensure that the other deadlines of the Regulation can still be met. For legal/linguistic reasons, a minor redrafting was also made in the second subparagraph of this paragraph. |
| --- | --- |

33.

The Council shares the position of the European Parliament that it is important that the Paediatric Committee be established within six months after the entry into force of the Regulation and has therefore included Amendment 20 in the first subparagraph of Article 3(1), together with a redrafting to ensure that the other deadlines of the Regulation can still be met. For legal/linguistic reasons, a minor redrafting was also made in the second subparagraph of this paragraph.

| 34. | Article 4 of the Proposal deals with the composition of the Paediatric Committee. Here, the Council, in analogy to what is the case for the Committee for Human Medicinal Products, has decided to introduce alternates for the members and to specify the procedure for their appointment.
  The Council has also accepted in principle in subparagraphs (c) and (d) of Article 4(1) Amendment 21 proposed by the European Parliament but with redrafting. The Council accepted the part of the amendment that concerns consultation of the European Parliament. In view of the introduction of alternates, the Council considers that six members are sufficient to represent the interests of healthcare professionals and patient associations. However, the Council considers that it should be made clear that three members should represent healthcare professionals and three members should represent patient associations. The list of disciplines represented on the Committee applies to the Committee as a whole and should be incorporated in the list of disciplines set out at the end of the paragraph. |
| --- | --- |

34.

Article 4 of the Proposal deals with the composition of the Paediatric Committee. Here, the Council, in analogy to what is the case for the Committee for Human Medicinal Products, has decided to introduce alternates for the members and to specify the procedure for their appointment.

The Council has also accepted in principle in subparagraphs (c) and (d) of Article 4(1) Amendment 21 proposed by the European Parliament but with redrafting. The Council accepted the part of the amendment that concerns consultation of the European Parliament. In view of the introduction of alternates, the Council considers that six members are sufficient to represent the interests of healthcare professionals and patient associations. However, the Council considers that it should be made clear that three members should represent healthcare professionals and three members should represent patient associations. The list of disciplines represented on the Committee applies to the Committee as a whole and should be incorporated in the list of disciplines set out at the end of the paragraph.

| 35. | Article 5(1) sets out the procedure for agreeing an opinion in the Paediatric Committee. Here, the Council has integrated in principle Amendment 22. The first part has been accepted with minor redrafting to improve clarity. The Council supports the transparency intended in the second part, but considers that the provision should be included in Article 25, which deals with procedural issues, including transparency.
  As for Amendment 23 to Article 5(3), the Council considers it unnecessary to define the respective numbers of representatives of the Commission or Executive Director of the Agency that could attend the meetings of the Paediatric Committee. |
| --- | --- |

35.

Article 5(1) sets out the procedure for agreeing an opinion in the Paediatric Committee. Here, the Council has integrated in principle Amendment 22. The first part has been accepted with minor redrafting to improve clarity. The Council supports the transparency intended in the second part, but considers that the provision should be included in Article 25, which deals with procedural issues, including transparency.

As for Amendment 23 to Article 5(3), the Council considers it unnecessary to define the respective numbers of representatives of the Commission or Executive Director of the Agency that could attend the meetings of the Paediatric Committee.

| 36. | The Council has decided to delete Article 6 of the Proposal on independence and impartiality of the members of the Paediatric Committee, since detailed provisions on such requirements are already set out in Regulation (EC) No 726/2004, to which explicit reference is made in Article 3(2). For this reason, the Council cannot support Amendment 24. |
| --- | --- |

36.

The Council has decided to delete Article 6 of the Proposal on independence and impartiality of the members of the Paediatric Committee, since detailed provisions on such requirements are already set out in Regulation (EC) No 726/2004, to which explicit reference is made in Article 3(2). For this reason, the Council cannot support Amendment 24.

| 37. | Article 6 of the common position sets out the tasks of the Paediatric Committee. Here, the Council supports the objective of Amendment 25 to paragraph (1)(g), but notes that the Regulation already provides for free scientific advice in Article 27. Also, Article 47(3) provides that assessments by the Committee will be free of charge. If this amendment were to be included it would, for reasons of consistency, be necessary to specify ‘free of charge’ for all other tasks listed in Article 6(1), and therefore the Council cannot support it.
  The Council agrees in principle to Amendments 26 and 29 by the European Parliament to form a new subparagraph (i) of Article 6(1) on establishment of an inventory of paediatric medicinal products needs. But the Council noted that this requires amendment of subparagraph (e) of Article 6(1) in order to avoid unnecessary repetition.
  The Council supports the principle that the Committee should advise on communication about the conduct of clinical trials in children (Amendment 27) and therefore agrees to introduce a new subparagraph (j) of Article 6(1), but does not consider it appropriate for the Paediatric Committee to have a self-promoting function.
  Further, the Council has added a new subparagraph (k) of Article 6(1) concerning the selection of the symbol for paediatric medicines (see Article 32).
  Finally, the Council has included Amendment 28 on advice available from third countries in Article 6(2) with minor redrafting to improve clarity. |
| --- | --- |

37.

Article 6 of the common position sets out the tasks of the Paediatric Committee. Here, the Council supports the objective of Amendment 25 to paragraph (1)(g), but notes that the Regulation already provides for free scientific advice in Article 27. Also, Article 47(3) provides that assessments by the Committee will be free of charge. If this amendment were to be included it would, for reasons of consistency, be necessary to specify ‘free of charge’ for all other tasks listed in Article 6(1), and therefore the Council cannot support it.

The Council agrees in principle to Amendments 26 and 29 by the European Parliament to form a new subparagraph (i) of Article 6(1) on establishment of an inventory of paediatric medicinal products needs. But the Council noted that this requires amendment of subparagraph (e) of Article 6(1) in order to avoid unnecessary repetition.

The Council supports the principle that the Committee should advise on communication about the conduct of clinical trials in children (Amendment 27) and therefore agrees to introduce a new subparagraph (j) of Article 6(1), but does not consider it appropriate for the Paediatric Committee to have a self-promoting function.

Further, the Council has added a new subparagraph (k) of Article 6(1) concerning the selection of the symbol for paediatric medicines (see Article 32).

Finally, the Council has included Amendment 28 on advice available from third countries in Article 6(2) with minor redrafting to improve clarity.

Title II — Marketing authorisation requirements

| 38. | Article 7 deals with General authorisation requirements. The Council considers that Amendment 30, which opens a possibility to provide information on ongoing paediatric studies, is not necessary. The Commission Proposal does not require the completion of all paediatric studies at the time of application for marketing authorisation. The ‘deferral’ provision allows for delay in the initiation of paediatric clinical studies so as to ensure that the studies are only done when it is safe and ethical to do so. The Commission Proposal also provides for the deferral decision to contain a timetable to complete the studies. The Council agrees with the Commission proposal in these respects. |
| --- | --- |

38.

Article 7 deals with General authorisation requirements. The Council considers that Amendment 30, which opens a possibility to provide information on ongoing paediatric studies, is not necessary. The Commission Proposal does not require the completion of all paediatric studies at the time of application for marketing authorisation. The ‘deferral’ provision allows for delay in the initiation of paediatric clinical studies so as to ensure that the studies are only done when it is safe and ethical to do so. The Commission Proposal also provides for the deferral decision to contain a timetable to complete the studies. The Council agrees with the Commission proposal in these respects.

| 39. | Article 8 also deals with General authorisation requirements. This Article has been slightly redrafted to clarify the scope.
  The Council agrees in principle with the ideas behind Amendment 31 to Article 8, but considers this amendment to be redundant. Article 27 already refers to the application of Regulation (EC) No 726/2004 and Directive 2001/83/EC, which by association includes their implementing measures such as the variation regulations, in particular Commission Regulation (EC) No 1085/2003, to which the amendment introduces a reference.
  The Council also considers that Amendment 32 is not necessary, since Article 28(1) of the proposed Regulation already opens the centralised procedure to marketing authorisation applications which include one or more paediatric indications selected on the basis of studies conducted in compliance with an agreed paediatric investigation plan. In addition, Article 29 provides that applications referred to in Article 8 relating to products authorised through the mutual recognition procedure may obtain an opinion from the Committee on Human Medicinal Products of the European Medicines Agency. This in turn will lead to a Commission Decision which will be binding on Member States. |
| --- | --- |

39.

Article 8 also deals with General authorisation requirements. This Article has been slightly redrafted to clarify the scope.

The Council agrees in principle with the ideas behind Amendment 31 to Article 8, but considers this amendment to be redundant. Article 27 already refers to the application of Regulation (EC) No 726/2004 and Directive 2001/83/EC, which by association includes their implementing measures such as the variation regulations, in particular Commission Regulation (EC) No 1085/2003, to which the amendment introduces a reference.

The Council also considers that Amendment 32 is not necessary, since Article 28(1) of the proposed Regulation already opens the centralised procedure to marketing authorisation applications which include one or more paediatric indications selected on the basis of studies conducted in compliance with an agreed paediatric investigation plan. In addition, Article 29 provides that applications referred to in Article 8 relating to products authorised through the mutual recognition procedure may obtain an opinion from the Committee on Human Medicinal Products of the European Medicines Agency. This in turn will lead to a Commission Decision which will be binding on Member States.

| 40. | The provisions in Article 10 on compliance checks of paediatric investigation plans have been adjusted to clarify the responsibilities of various actors. |
| --- | --- |

40.

The provisions in Article 10 on compliance checks of paediatric investigation plans have been adjusted to clarify the responsibilities of various actors.

| 41. | The Council agrees to Amendment 33, which states that the Paediatric Committee should appoint a rapporteur as part of the preparation of decisions on product specific waivers (first subparagraph of Article 13(2)).
  The Council also agrees in principle to Amendment 34 in Article 13(3). But the reference to informing the applicant has been moved to Article 25 to improve coherence in the text. The deadline has been changed to ‘10 days’ as it is not the practice to use the term ‘working days’ in the Community legislation relating to medicinal products. |
| --- | --- |

41.

The Council agrees to Amendment 33, which states that the Paediatric Committee should appoint a rapporteur as part of the preparation of decisions on product specific waivers (first subparagraph of Article 13(2)).

The Council also agrees in principle to Amendment 34 in Article 13(3). But the reference to informing the applicant has been moved to Article 25 to improve coherence in the text. The deadline has been changed to ‘10 days’ as it is not the practice to use the term ‘working days’ in the Community legislation relating to medicinal products.

| 42. | In Article 14(1), the Council agrees to Amendment 35 on updating and public availability of the list of waivers. |
| --- | --- |

42.

In Article 14(1), the Council agrees to Amendment 35 on updating and public availability of the list of waivers.

| 43. | Article 16 sets out provisions for the timing of the submission of the Paediatric Investigation Plan. The European Parliament had proposed three amendments (36, 37 and 38) to this Article. The Council cannot support these for the following reasons:
  The Council agrees with the Commission proposal that provides for the summary report to be prepared by the Agency. This is consistent with the operating methods of the Committee on Orphan Medicinal Products. Ten days are inadequate for the preparation of the summary report by the Agency.
  The introduction of the paediatric investigation plan into the legal framework concerning medicinal products for human use aims at ensuring that the development of medicines for children becomes integrated into the overall development programme for medicinal products. The Council agrees that it is appropriate, therefore, to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee on whether studies are required and, if so, the type of studies and their timing compared to studies in adults.
  The deadline provided for in Article 16(1) of the proposed Regulation is a dead-line to submit a draft plan and not a dead-line for the initiation of studies. In addition, the plan may contain a request for a deferral of the initiation or completion of studies.
  The Commission proposal provides a mechanism for the modification of the paediatric investigation plan. This will ensures continuing dialogue between the applicant and the Paediatric Committee during the product development.
  The Council considers that the proposed amendment would result in little, if any, investigation of the use of a product in children early in the product's development. This would impede innovation in paediatric therapeutics and have negative consequences for public health. |
| --- | --- |

43.

Article 16 sets out provisions for the timing of the submission of the Paediatric Investigation Plan. The European Parliament had proposed three amendments (36, 37 and 38) to this Article. The Council cannot support these for the following reasons:

The Council agrees with the Commission proposal that provides for the summary report to be prepared by the Agency. This is consistent with the operating methods of the Committee on Orphan Medicinal Products. Ten days are inadequate for the preparation of the summary report by the Agency.

The introduction of the paediatric investigation plan into the legal framework concerning medicinal products for human use aims at ensuring that the development of medicines for children becomes integrated into the overall development programme for medicinal products. The Council agrees that it is appropriate, therefore, to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee on whether studies are required and, if so, the type of studies and their timing compared to studies in adults.

The deadline provided for in Article 16(1) of the proposed Regulation is a dead-line to submit a draft plan and not a dead-line for the initiation of studies. In addition, the plan may contain a request for a deferral of the initiation or completion of studies.

The Commission proposal provides a mechanism for the modification of the paediatric investigation plan. This will ensures continuing dialogue between the applicant and the Paediatric Committee during the product development.

The Council considers that the proposed amendment would result in little, if any, investigation of the use of a product in children early in the product's development. This would impede innovation in paediatric therapeutics and have negative consequences for public health.

| 44. | In Article 17(1) on handling of a proposal for a paediatric investigation plan, the Council has included Amendment 39 with a minor addition to improve clarity, and also clarified the scope. |
| --- | --- |

44.

In Article 17(1) on handling of a proposal for a paediatric investigation plan, the Council has included Amendment 39 with a minor addition to improve clarity, and also clarified the scope.

| 45. | Article 22 deals with the modification of a paediatric investigation plan. Here, the Council agrees to the first two parts of Amendment 40. The last part has not been accepted since the Proposal provides that the applicant has to request modifications to an agreed plan. As this request is the modified plan, it is unnecessary for the opinion on the modified plan to contain a dead-line for the submission of the modified plan. |
| --- | --- |

45.

Article 22 deals with the modification of a paediatric investigation plan. Here, the Council agrees to the first two parts of Amendment 40. The last part has not been accepted since the Proposal provides that the applicant has to request modifications to an agreed plan. As this request is the modified plan, it is unnecessary for the opinion on the modified plan to contain a dead-line for the submission of the modified plan.

| 46. | The provisions in Article 23 on compliance checks of paediatric investigation plans have been adjusted to clarify the responsibilities of various actors. |
| --- | --- |

46.

The provisions in Article 23 on compliance checks of paediatric investigation plans have been adjusted to clarify the responsibilities of various actors.

| 47. | The Council has inserted a number of amendments to Article 25 in order to clarify the procedure and support transparency. The second part of Amendment 22 from the European Parliament (compare Article 5) has been included, as has Amendment 42 to Article 25(5), with minor redrafting. The Council considers that ten days should be sufficient time for the Agency to adopt a decision. The Council is however not able to support Amendment 41, since details on the interaction between the rapporteurs and the applicants should be set out in the rules of procedure of the Paediatric Committee. |
| --- | --- |

47.

The Council has inserted a number of amendments to Article 25 in order to clarify the procedure and support transparency. The second part of Amendment 22 from the European Parliament (compare Article 5) has been included, as has Amendment 42 to Article 25(5), with minor redrafting. The Council considers that ten days should be sufficient time for the Agency to adopt a decision. The Council is however not able to support Amendment 41, since details on the interaction between the rapporteurs and the applicants should be set out in the rules of procedure of the Paediatric Committee.

Title III — Marketing authorisation procedures

| 48. | Article 28 deals with marketing authorisation procedures for applications falling within the scope of Articles 7 and 8. Parts one and two of Amendment 43 are adopted in principle in the second subparagraph of Article 28(1), but the Council suggests some minor redrafting. The third part has not been accepted as there are detailed scientific Community guidelines on the presentation of information on indications that have been approved, not approved and contra-indicated. The aims of this amendment are achieved through the application of these guidelines, which are amended regularly to take account of technical progress. The Council has also introduced changes to paragraph 3 in order to meet concerns on double rewards similar to those raised by the European Parliament in Amendment 52 (see Article 36 below). |
| --- | --- |

48.

Article 28 deals with marketing authorisation procedures for applications falling within the scope of Articles 7 and 8. Parts one and two of Amendment 43 are adopted in principle in the second subparagraph of Article 28(1), but the Council suggests some minor redrafting. The third part has not been accepted as there are detailed scientific Community guidelines on the presentation of information on indications that have been approved, not approved and contra-indicated. The aims of this amendment are achieved through the application of these guidelines, which are amended regularly to take account of technical progress. The Council has also introduced changes to paragraph 3 in order to meet concerns on double rewards similar to those raised by the European Parliament in Amendment 52 (see Article 36 below).

| 49. | The definition of a paediatric use marketing authorisation was moved from Article 30 to Article 2 for reasons of clarity. |
| --- | --- |

49.

The definition of a paediatric use marketing authorisation was moved from Article 30 to Article 2 for reasons of clarity.

| 50. | Article 32 deals with the identification of medicinal products for paediatric use. Here, the Council introduced a number of changes, notably to clarify that all medicinal product granted a marketing authorisation for a paediatric indication should display a specific symbol on their labels, and to clarify the procedure for selecting this symbol.
  The European Parliament had proposed two amendments to this Article. The Council agrees in principle to the first part of Amendment 44, but with a suggested redraft. The second part cannot be accepted as the Council considers that it is preferable to make use of available expertise and adopt the symbol with the minimum delay. The Council agrees, therefore, that the Commission should adopt the symbol based on a recommendation from the Paediatric Committee.
  The Council accepts in principle Amendment 45 and has therefore introduced a new subparagraph in Article 32. The Council, however considers that it would be confusing for the patient and carer if some, but not all, products authorised for paediatric use were identified by a Community symbol on the label. The symbol, therefore, should apply to all medicinal products with a paediatric indication. In addition, the meaning of the symbol should be explained in the patient information leaflet and a deadline should be introduced for the application of the symbol. |
| --- | --- |

50.

Article 32 deals with the identification of medicinal products for paediatric use. Here, the Council introduced a number of changes, notably to clarify that all medicinal product granted a marketing authorisation for a paediatric indication should display a specific symbol on their labels, and to clarify the procedure for selecting this symbol.

The European Parliament had proposed two amendments to this Article. The Council agrees in principle to the first part of Amendment 44, but with a suggested redraft. The second part cannot be accepted as the Council considers that it is preferable to make use of available expertise and adopt the symbol with the minimum delay. The Council agrees, therefore, that the Commission should adopt the symbol based on a recommendation from the Paediatric Committee.

The Council accepts in principle Amendment 45 and has therefore introduced a new subparagraph in Article 32. The Council, however considers that it would be confusing for the patient and carer if some, but not all, products authorised for paediatric use were identified by a Community symbol on the label. The symbol, therefore, should apply to all medicinal products with a paediatric indication. In addition, the meaning of the symbol should be explained in the patient information leaflet and a deadline should be introduced for the application of the symbol.

Title IV — Post-authorisation requirements

| 51. | Article 33 deals with the deadline for placing products authorised for a paediatric indication on the market. The second part of Amendment 46 has been included in Article 33, with a slight redrafting. The Council considers that the register should be coordinated by the European Medicines Agency. In order to maintain flexibility, no reference to the competent authorities is made, since it may be possible to use existing databases for the register. The Council does not accept the first part; since it considers it inappropriate to include a provision that does not create any legal obligation. The Council supports the text of the Commission Proposal which makes it clear that the legal obligation is to market within two years. In addition, the Council does not agree to the third part of the amendment (which corresponds to Amendment 11). Existing EC pharmaceutical legislation sets out clear dead-lines both for the granting of a marketing authorisation and for national decisions concerning the pricing and reimbursement for medicinal products. The Council considers that it is inappropriate, therefore, to provide for derogations in the application of this provision in cases where competent authorities are unable to meet such deadlines. |
| --- | --- |

51.

Article 33 deals with the deadline for placing products authorised for a paediatric indication on the market. The second part of Amendment 46 has been included in Article 33, with a slight redrafting. The Council considers that the register should be coordinated by the European Medicines Agency. In order to maintain flexibility, no reference to the competent authorities is made, since it may be possible to use existing databases for the register. The Council does not accept the first part; since it considers it inappropriate to include a provision that does not create any legal obligation. The Council supports the text of the Commission Proposal which makes it clear that the legal obligation is to market within two years. In addition, the Council does not agree to the third part of the amendment (which corresponds to Amendment 11). Existing EC pharmaceutical legislation sets out clear dead-lines both for the granting of a marketing authorisation and for national decisions concerning the pricing and reimbursement for medicinal products. The Council considers that it is inappropriate, therefore, to provide for derogations in the application of this provision in cases where competent authorities are unable to meet such deadlines.

| 52. | Article 34(2) deals with risk management systems when the Competent Authority has cause for concern. The European Parliament, in Amendment 47, proposed to make such a system compulsory. The Council recalls that the EC pharmaceutical legislation has recently been amended and now contains strengthened and new pharmacovigilance measures, including risk management systems. The proposed Regulation contains a provision for the competent authority, whenever it has cause for concern, to require a risk management system to be put in place. The Council does not find it appropriate to make this provision compulsory, as there may be occasions when such a requirement would add an unnecessary burden and may present a barrier to access to appropriate medicines.
  Although the Council supports the objective of Amendments 48, 49 and 83 that introduce new provisions on pharmacovigilance, they are not considered to be necessary; since provisions relating to the communication of information on pharmacovigilance matters already exist in EC pharmaceutical legislation and apply to all medicinal products authorised in the Community (Article 24(5) of Regulation (EC) No 726/2004 and Article 104(9) of Directive 2001/83/EC). |
| --- | --- |

52.

Article 34(2) deals with risk management systems when the Competent Authority has cause for concern. The European Parliament, in Amendment 47, proposed to make such a system compulsory. The Council recalls that the EC pharmaceutical legislation has recently been amended and now contains strengthened and new pharmacovigilance measures, including risk management systems. The proposed Regulation contains a provision for the competent authority, whenever it has cause for concern, to require a risk management system to be put in place. The Council does not find it appropriate to make this provision compulsory, as there may be occasions when such a requirement would add an unnecessary burden and may present a barrier to access to appropriate medicines.

Although the Council supports the objective of Amendments 48, 49 and 83 that introduce new provisions on pharmacovigilance, they are not considered to be necessary; since provisions relating to the communication of information on pharmacovigilance matters already exist in EC pharmaceutical legislation and apply to all medicinal products authorised in the Community (Article 24(5) of Regulation (EC) No 726/2004 and Article 104(9) of Directive 2001/83/EC).

| 53. | The Council has decided to insert a new Article 35 to ensure that products with a paediatric indication for which the market authorisation holder has benefited from the rewards in this Regulation stay on the market. This new article is very similar to Amendment 50 of the European Parliament, with some redrafting. The Council supports the principle behind this amendment, but considers that there is a need for a corresponding recital and has introduced some redrafting to clarify both the scope and that any third party should have expressed an intention to continue marketing the product. Also the Council considers that there should be a dead-line for informing the Agency of the intention to discontinue placing a product on the market. |
| --- | --- |

53.

The Council has decided to insert a new Article 35 to ensure that products with a paediatric indication for which the market authorisation holder has benefited from the rewards in this Regulation stay on the market. This new article is very similar to Amendment 50 of the European Parliament, with some redrafting. The Council supports the principle behind this amendment, but considers that there is a need for a corresponding recital and has introduced some redrafting to clarify both the scope and that any third party should have expressed an intention to continue marketing the product. Also the Council considers that there should be a dead-line for informing the Agency of the intention to discontinue placing a product on the market.

Title V — Rewards and incentives

| 54. | Article 36 deals with the requirements that must be met in order for a Supplementary Protection Certificate (SPC) to be prolonged six months.
  One objective of the proposed Regulation is to ensure that safe and effective authorised medicines are available for children. Therefore, one of the criteria for granting an extension of the period set out in the SPC should be that the product must be authorised in all Member States. The same principle applies to the reward of market exclusivity provided for in the Regulation on orphan medicinal products. For this reason, the Council cannot agree to Amendment 51. In addition, the proposed Regulation requires that the information from the completed paediatric investigation plan must be included in the summary of product characteristics before SPC extension can be granted. Marketing authorisation procedures, therefore, must be completed before the SPC extension can be granted. For the same reasons, the associated Amendment 14 to recital 26 has also been rejected.
  Article 36(4) states which products are entitled to a six month prolongation of the SPC. Here, the second part of Amendment 52 has been accepted in principle. The Council supports the principle of avoiding double rewards gained on the basis of the same research in the following particular situation. The new Article 10(1) of Directive 2001/83/EC as amended by Directive 2004/27/EC, provides that the period of market protection shall be extended by one year if the marketing authorisation holder obtains an authorisation for a new indication which is judged to bring significant clinical benefit in comparison with existing therapies. In the case of a new paediatric indication, this additional year of market protection should not be granted together with the six-month extension when based on the same research. To avoid this cumulative reward, the Council has introduced a new paragraph in Article 36.
  The Council cannot agree to the first part of the amendment, which relates to patents. A basic patent (protecting the molecule) covers all medicinal uses of the substance, hence it covers also any paediatric medicinal use. A specific paediatric patent only exists in the case of a so-called ‘usage patent’. The Commission proposal prolongs the basic patent; in such circumstances it would be difficult to operate the ‘non-cumulative’ test set out in the first part of the amendment and it would go against the objective of stimulating innovation and research. However, consistent with the spirit of the amendment, the Council considers that there is a need to clarify that the rewards and incentives which resulted from completion of an agreed paediatric investigation plan should only be available if at least some significant research was completed after the entry into force of the Regulation. Amendments have therefore been introduced into Articles 28(3) and 45(3).
  Amendment 53 proposes to introduce a new paragraph stating that the prolongation should only be admissible once per medicinal product. The Council does not consider that this amendment is necessary since this provision is already provided for in Article 52, indent 7, which amends Article 13 of Regulation (EEC) No 1768/92 (the SPC Regulation). |
| --- | --- |

54.

Article 36 deals with the requirements that must be met in order for a Supplementary Protection Certificate (SPC) to be prolonged six months.

One objective of the proposed Regulation is to ensure that safe and effective authorised medicines are available for children. Therefore, one of the criteria for granting an extension of the period set out in the SPC should be that the product must be authorised in all Member States. The same principle applies to the reward of market exclusivity provided for in the Regulation on orphan medicinal products. For this reason, the Council cannot agree to Amendment 51. In addition, the proposed Regulation requires that the information from the completed paediatric investigation plan must be included in the summary of product characteristics before SPC extension can be granted. Marketing authorisation procedures, therefore, must be completed before the SPC extension can be granted. For the same reasons, the associated Amendment 14 to recital 26 has also been rejected.

Article 36(4) states which products are entitled to a six month prolongation of the SPC. Here, the second part of Amendment 52 has been accepted in principle. The Council supports the principle of avoiding double rewards gained on the basis of the same research in the following particular situation. The new Article 10(1) of Directive 2001/83/EC as amended by Directive 2004/27/EC, provides that the period of market protection shall be extended by one year if the marketing authorisation holder obtains an authorisation for a new indication which is judged to bring significant clinical benefit in comparison with existing therapies. In the case of a new paediatric indication, this additional year of market protection should not be granted together with the six-month extension when based on the same research. To avoid this cumulative reward, the Council has introduced a new paragraph in Article 36.

The Council cannot agree to the first part of the amendment, which relates to patents. A basic patent (protecting the molecule) covers all medicinal uses of the substance, hence it covers also any paediatric medicinal use. A specific paediatric patent only exists in the case of a so-called ‘usage patent’. The Commission proposal prolongs the basic patent; in such circumstances it would be difficult to operate the ‘non-cumulative’ test set out in the first part of the amendment and it would go against the objective of stimulating innovation and research. However, consistent with the spirit of the amendment, the Council considers that there is a need to clarify that the rewards and incentives which resulted from completion of an agreed paediatric investigation plan should only be available if at least some significant research was completed after the entry into force of the Regulation. Amendments have therefore been introduced into Articles 28(3) and 45(3).

Amendment 53 proposes to introduce a new paragraph stating that the prolongation should only be admissible once per medicinal product. The Council does not consider that this amendment is necessary since this provision is already provided for in Article 52, indent 7, which amends Article 13 of Regulation (EEC) No 1768/92 (the SPC Regulation).

| 55. | The Council is unable to support Amendment 54 proposed to Article 37 since orphan medicinal products are subject to the same authorisation procedures as other medicinal products. There are already provisions in EC pharmaceutical legislation to allow, where necessary, the early authorisation of orphan medicinal products, such as the provisions for accelerated assessment or conditional marketing authorisation set out in Regulation (EC) No 726/2004 (Article 14). |
| --- | --- |

55.

The Council is unable to support Amendment 54 proposed to Article 37 since orphan medicinal products are subject to the same authorisation procedures as other medicinal products. There are already provisions in EC pharmaceutical legislation to allow, where necessary, the early authorisation of orphan medicinal products, such as the provisions for accelerated assessment or conditional marketing authorisation set out in Regulation (EC) No 726/2004 (Article 14).

| 56. | Article 39(3) deals with an inventory of incentives provided by the Community and Member States to support research into, and the development and availability of, medicinal products for paediatric use. In Amendment 55, the European Parliament proposes to make this publicly available. The Council agrees to this and has included the amendment with some minor redrafting to improve clarity. |
| --- | --- |

56.

Article 39(3) deals with an inventory of incentives provided by the Community and Member States to support research into, and the development and availability of, medicinal products for paediatric use. In Amendment 55, the European Parliament proposes to make this publicly available. The Council agrees to this and has included the amendment with some minor redrafting to improve clarity.

| 57. | Like the European Parliament, the Council strongly supports the inclusion of a specific reference to the funding of studies on the paediatric use of off-patent medicinal products, in form of a new Article 40, but suggests redrafting compared to Amendments 56, 63 and 64. The Council considers that the specific name of the programme should not be given in the Regulation. Also the funding should be delivered through the Community Framework Programmes or any other Community initiatives for the funding of research. Furthermore, the Council considers that the reference to the study programme should be included only in Article 40, and not in Article 48. |
| --- | --- |

57.

Like the European Parliament, the Council strongly supports the inclusion of a specific reference to the funding of studies on the paediatric use of off-patent medicinal products, in form of a new Article 40, but suggests redrafting compared to Amendments 56, 63 and 64. The Council considers that the specific name of the programme should not be given in the Regulation. Also the funding should be delivered through the Community Framework Programmes or any other Community initiatives for the funding of research. Furthermore, the Council considers that the reference to the study programme should be included only in Article 40, and not in Article 48.

Title VI — Communication and coordination

| 58. | Article 41(1) deals with a European database on clinical trials. Like the European Parliament, the Council supports the introduction of transparency into the paediatric clinical trials database, but agrees that clarification is needed regarding what is to be included and how the details would be entered into the database. Amendment 57 has therefore been included in paragraph 1 and a new paragraph 2, with some redrafting, as has Amendment 58 on guidance. |
| --- | --- |

58.

Article 41(1) deals with a European database on clinical trials. Like the European Parliament, the Council supports the introduction of transparency into the paediatric clinical trials database, but agrees that clarification is needed regarding what is to be included and how the details would be entered into the database. Amendment 57 has therefore been included in paragraph 1 and a new paragraph 2, with some redrafting, as has Amendment 58 on guidance.

| 59. | The Council has introduced deadlines in Article 42 on collection of existing data on use of medicinal products in the paediatric population. |
| --- | --- |

59.

The Council has introduced deadlines in Article 42 on collection of existing data on use of medicinal products in the paediatric population.

| 60. | Article 43 deals with the inventory of paediatric needs. The Council agrees with the ideas behind the amendments to the text as set out in the first and second parts of the new Article 2b proposed in Amendment 19 by the European Parliament, and has redrafted Articles 43(2) and 43(3). The deadline has been extended to three years to ensure that there is sufficient time to complete all phases of the work involved. The Council cannot agree to the amendments to the text set out in the other new articles of Amendment 19 because they either involve duplication of work or are incomplete. The Council does not support the proposal to change the structure of the Regulation, since it considers the structure of the Commission proposal to be more coherent. |
| --- | --- |

60.

Article 43 deals with the inventory of paediatric needs. The Council agrees with the ideas behind the amendments to the text as set out in the first and second parts of the new Article 2b proposed in Amendment 19 by the European Parliament, and has redrafted Articles 43(2) and 43(3). The deadline has been extended to three years to ensure that there is sufficient time to complete all phases of the work involved. The Council cannot agree to the amendments to the text set out in the other new articles of Amendment 19 because they either involve duplication of work or are incomplete. The Council does not support the proposal to change the structure of the Regulation, since it considers the structure of the Commission proposal to be more coherent.

| 61. | Article 45 deals with paediatric studies completed prior to the entry into force of the Regulation on Paediatric Medicines. The Council has clarified the scope of this Article. Here and in Article 46, the wording has been changed to make it clear that the Competent Authority has the discretion to decide whether or not to vary a marketing authorisation. It should be noted that the Competent Authority, when deciding on the action to take, is subject to pharmacovigilance provisions in Community law. The Council shares the intentions behind Amendments 62 and 69, but considers that both amendments should be included in Article 45(2) and not in Article 56. In response to parts of Amendment 52, the Council decided to modify Article 45(3) (compare Article 36 above). |
| --- | --- |

61.

Article 45 deals with paediatric studies completed prior to the entry into force of the Regulation on Paediatric Medicines. The Council has clarified the scope of this Article. Here and in Article 46, the wording has been changed to make it clear that the Competent Authority has the discretion to decide whether or not to vary a marketing authorisation. It should be noted that the Competent Authority, when deciding on the action to take, is subject to pharmacovigilance provisions in Community law. The Council shares the intentions behind Amendments 62 and 69, but considers that both amendments should be included in Article 45(2) and not in Article 56. In response to parts of Amendment 52, the Council decided to modify Article 45(3) (compare Article 36 above).

Title VII — General and final provisions

| 62. | Article 48 deals with the Community contribution to the European Medicines Agency. The Council agrees in principle to Amendment 63. The first part has been included in Article 48 with minor redrafting. For the second part, the Council considers that the reference to the study programme should be included in Article 40, and not in Article 48. |
| --- | --- |

62.

Article 48 deals with the Community contribution to the European Medicines Agency. The Council agrees in principle to Amendment 63. The first part has been included in Article 48 with minor redrafting. For the second part, the Council considers that the reference to the study programme should be included in Article 40, and not in Article 48.

| 63. | Article 49 deals with penalties for infringements of the Regulation. The Council supports the intentions behind Amendment 66, and has included it, with some minor redrafting. The Council considers that the harmonisation of national measures proposed in Amendment 65 would require the adoption of Community legislation to this aim, and can therefore not support this amendment. |
| --- | --- |

63.

Article 49 deals with penalties for infringements of the Regulation. The Council supports the intentions behind Amendment 66, and has included it, with some minor redrafting. The Council considers that the harmonisation of national measures proposed in Amendment 65 would require the adoption of Community legislation to this aim, and can therefore not support this amendment.

| 64. | Article 50 of the common position deals with reports to be prepared by the European Commission. The Council discussed in detail the necessary analysis of the impact of the reward mechanisms. It agrees, in principle, to Amendment 67 and has included it in Article 50(3) with some redrafting. The Council fully supports a provision for the Commission to carry out detailed analyses of the economic impact resulting from the application of the Regulation. However, the Council wishes to ensure that there are sufficient data available to make robust analyses. Since this might not be the case already after six years, the analysis of economic impact could take place later, but within ten years. In addition the Council decided that there should be an analysis of the estimated consequences for public health. |
| --- | --- |

64.

Article 50 of the common position deals with reports to be prepared by the European Commission. The Council discussed in detail the necessary analysis of the impact of the reward mechanisms. It agrees, in principle, to Amendment 67 and has included it in Article 50(3) with some redrafting. The Council fully supports a provision for the Commission to carry out detailed analyses of the economic impact resulting from the application of the Regulation. However, the Council wishes to ensure that there are sufficient data available to make robust analyses. Since this might not be the case already after six years, the analysis of economic impact could take place later, but within ten years. In addition the Council decided that there should be an analysis of the estimated consequences for public health.

| 65. | The Council decided to delete Article 50 of the Proposal, since it considers that the provisions in Article 6 of the common position are sufficient as a basis for rules of procedure for the Paediatric Committee, which should be decided within EMEA in order guarantee flexibility. |
| --- | --- |

65.

The Council decided to delete Article 50 of the Proposal, since it considers that the provisions in Article 6 of the common position are sufficient as a basis for rules of procedure for the Paediatric Committee, which should be decided within EMEA in order guarantee flexibility.

| 66. | Article 51 on comitology has been adapted to correspond to standard wording. |
| --- | --- |

66.

Article 51 on comitology has been adapted to correspond to standard wording.

| 67. | Article 52 contains amendments necessary to Regulation (EEC)1768/92, the SPC Regulation. In particular, a new paragraph 4 is inserted into Article 7 of Regulation (EEC)1768/92, stating that the application for an SPC prolongation shall be lodged no later than two years before the expiration of the SPC. The Council considers that the two-year deadline in the Proposal is necessary to ensure transparency for generic competition. The Council can therefore not support Amendment 68, which shortens the deadline to six months.
  Following detailed ‘technical’ examination of the proposed amendments to the SPC Regulation, the Council has decided to change some of the provisions of the Proposal and has also introduced some new amendments to this Regulation. |
| --- | --- |

67.

Article 52 contains amendments necessary to Regulation (EEC)1768/92, the SPC Regulation. In particular, a new paragraph 4 is inserted into Article 7 of Regulation (EEC)1768/92, stating that the application for an SPC prolongation shall be lodged no later than two years before the expiration of the SPC. The Council considers that the two-year deadline in the Proposal is necessary to ensure transparency for generic competition. The Council can therefore not support Amendment 68, which shortens the deadline to six months.

Following detailed ‘technical’ examination of the proposed amendments to the SPC Regulation, the Council has decided to change some of the provisions of the Proposal and has also introduced some new amendments to this Regulation.

| 68. | The Council has inserted a new Article 53 in order to introduce an amendment to Directive 2001/20/EC aiming at making public part of the information on paediatric clinical trials entered in the European database on clinical trials. |
| --- | --- |

68.

The Council has inserted a new Article 53 in order to introduce an amendment to Directive 2001/20/EC aiming at making public part of the information on paediatric clinical trials entered in the European database on clinical trials.

| 69. | Article 57 deals with the entry into force of the provisions of the proposed regulation. Since there is no legal basis in current legislation nor any sufficiently empowered existing committee to agree paediatric investigation plans in advance of the entry into force of the Regulation, applications submitted before that date cannot include findings from studies which are part of an agreed paediatric investigation plan. Therefore, the Council cannot support Amendment 70. But research in advance of the entry into force of the Regulation is not discouraged. In accordance with Article 45(2) (Amendment 62), existing and on-going studies at the time of entry into force of the Regulation shall be eligible to be included in a paediatric investigation plan once the Regulation is adopted.
  The Council also considers that the suggested time-limits in Amendment 71 would not allow sufficient time for the necessary prior steps to be taken e.g. establishment of the Paediatric Committee or agreement of paediatric investigation plans, and can therefore not support this amendment. |
| --- | --- |

69.

Article 57 deals with the entry into force of the provisions of the proposed regulation. Since there is no legal basis in current legislation nor any sufficiently empowered existing committee to agree paediatric investigation plans in advance of the entry into force of the Regulation, applications submitted before that date cannot include findings from studies which are part of an agreed paediatric investigation plan. Therefore, the Council cannot support Amendment 70. But research in advance of the entry into force of the Regulation is not discouraged. In accordance with Article 45(2) (Amendment 62), existing and on-going studies at the time of entry into force of the Regulation shall be eligible to be included in a paediatric investigation plan once the Regulation is adopted.

The Council also considers that the suggested time-limits in Amendment 71 would not allow sufficient time for the necessary prior steps to be taken e.g. establishment of the Paediatric Committee or agreement of paediatric investigation plans, and can therefore not support this amendment.

IV.   CONCLUSION

| 70. | The Council has incorporated a considerable number of the European Parliament's amendments in its common position, which is fully in line with the objectives of the Commission proposal.
  The common position of the Council has the special health care needs of children as its main objective and strives to strike a balance between different considerations. The Commission has acknowledged the overall balance of the Council's common position and welcomed the Political Agreement at the Council (EPSCO) on 9 December 2005. |
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70.

The Council has incorporated a considerable number of the European Parliament's amendments in its common position, which is fully in line with the objectives of the Commission proposal.

The common position of the Council has the special health care needs of children as its main objective and strives to strike a balance between different considerations. The Commission has acknowledged the overall balance of the Council's common position and welcomed the Political Agreement at the Council (EPSCO) on 9 December 2005.

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(1)  OJ C 321, 28.12.2004, p. 12, text in doc. 13880/04 ECO 168 SAN 157 CODEC 1166.

(2)  OJ C 267, 27.10.2005, p. 1.

(3)  11956/05 CODEC 705 ECO 94 SAN 134.

(4)  14487/05 ECO 138 SAN 175 CODEC 1019.

(5)  OJ L 121, 01.05.2001, p. 34.

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