Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

2001/0254 (COD)

Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products

(Text with EEA relevance)

1. BACKGROUND

Transmission of the proposal to the Council and to the European Parliament - COM(2001) 404 final - 2001/0254 (COD) - by virtue of article 175, paragraph 1 of the Treaty: 26 November 2001

Opinion of the European Economic and Social Committee: 18 September 2002

Opinion of the European Parliament - first reading: 23 October 2002

2. OBJECTIVE OF THE COMMISSON PROPOSAL

Regulation 2309/93 provides for the possibility of an evaluation of the Community procedures for the authorisation and the supervision of medicinal products, which entered into force in 1995. In view of the experience gained during 1995 and 2000 and the analysis performed by the Commission in its report 'on the operation of the Community procedures for the marketing authorisation of medicinal products (COM(2001) 606 final of 23.10.2001)' it appeared necessary to amend Regulation 2309/93 and Directives 2001/83/EC and 2001/82/EC laying down the Community codes in relation to medicinal products for human and veterinary use.

In general, four major objectives appear to be particularly relevant.

(1) to assure a high level of public health protection, notably by making safe, innovative products available as quickly as possible, and by an increased supervision of the market through the strengthening of inspection procedures and of pharmacovigilance;

(2) to complete the single market for pharmaceutical products taking into account the stakes of globalisation and to establish a regulatory and legislative framework that favours the competitiveness of European industry;

(3) to respond to the challenges of the future enlargement of the European Union;

(4) to rationalise and simplify the system as well as to improve its overall coherence and visibility and the transparency of its procedures.

Finally with respect to veterinary medicines, the proposals aim specifically to take into account the problem of the availability of medicinal products for veterinary use.

3. OPINION OF THE COMMISSION ON THE AMENDMENTS ADOPTED BY THE PARLIAMENT

3.1. Amendments accepted by the Commission: 1, 15, 19, 20, 21, 22, 24, 28, 29, 31, 33, 34, 35, 39, 46 and 49.

The Commission can accept the following amendments with the wording proposed by the European Parliament. For certain provisions, other than those targeted by the amendments, incoherence with other provisions, or with the corresponding provisions in the proposal for a Directive relating to medicinal products for human use and in the Regulation laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Medicinal Products Agency, have been removed by amending the wording, where necessary.

- Amendment 1 aimed at introducing a reference to the need to protect public health:

"Recital 3:

It is therefore necessary to align the national laws, regulations and administrative provisions which contain differences with regard to the basic principles in order to promote the operation of the internal market, without adversely affecting public health."

- Amendment 15 aimed at requiring the applicant to submit documents as proof that he/she will be able to meet certain pharmacovigilance obligations:

"Article 12, paragraph 3, point na:

Proof that the applicant has the services of a qualified person responsible for pharmacovigilance and has equipment for the notification of any adverse reaction suspected of occurring either in the Community or in a third country."

- Amendment 19 aimed at specifying the order of the items to be mentioned in the summary of product characteristics:

"Article 14, introductory sentence:

The summary of the product characteristics shall contain, in the order indicated below, the following information:"

- Amendment 20 aimed at further specifying the incompatibilities concerned by the provision:

"Article 14, paragraph 6, point 6.1:

major incompatibilities;"

- Amendment 21 aimed at strengthening the need for Member States to take due account of registrations and authorisations of homeopathic veterinary medicinal products issued in other Member States:

"Article 16, paragraph 1:

Member States shall ensure that homeopathic veterinary medicinal products manufactured and marketed within the Community are registered or authorised in accordance with the provisions of Article 17(1) and (2), and Articles 18 and 19. Each Member State shall take due account of the registrations and authorisations issued by other Member States:"

- Amendment 22 aimed at defining the strength relating to effect of homeopathic medicinal products and to delete the reference to allopathic medicines, as this reference is incoherent with the proposal to allow the simplified registration procedure also for homeopathic veterinary medicinal products for food-producing species and the proposals regarding prescription requirements:

"Article 17, paragraph 1, point (c):

there is a sufficient degree of potentisation, which involves a sequential series of dilutions or succussions, to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10 000 of the mother tincture."

- Amendment 24 aimed at further defining the strength relating to effect of homeopathic medicinal products, as far as the method of manufacturing is concerned:

"Article 18, indent 3:

- manufacturing and control file for each pharmaceutical form and a description of the method of potentisation,"

- Amendment 28 aimed at altering the period of validity of the marketing authorisation in the case where this has not been followed by the placing on the market of the medicinal product. The same provision is introduced in the case of previously authorised medicinal products, which have not been on the market for a certain period. A derogation clause is introduced:

"Article 28, paragraph 2:

Any authorisation which is not followed within three years of its issue by the actual marketing of the authorised veterinary medicinal product in the authorising Member State shall cease to be valid.

The competent authority may, in exceptional circumstances, grant a derogation from the provisions of the previous subparagraph. The derogation shall be duly justified.

Article 28, paragraph 3:

When an authorised veterinary medicinal product previously placed on the market in the authorising Member State is no longer actually present on the market in that Member State for three consecutive years, the authorisation for that veterinary medicinal product shall cease to be valid.

The competent authority may, in exceptional circumstances, grant a derogation from the provisions of previous subparagraph. The derogation shall be duly justified."

- Amendment 29 aimed at making public the rules of procedure for the co-ordination group in charge of decentralised procedures for marketing authorisation:

"Article 31, paragraph 3:

The co-ordination group shall draw up its own rules of procedure, which shall enter into force after a favourable opinion of the Commission. These rules of procedure shall be made public."

- Amendment 31 aimed at providing a timetable for the work to be undertaken to harmonise the summary of product characteristics for veterinary medicinal products authorised for not less than ten year in the Community:

"Article 34, paragraph 2, subparagraph 4:

The Commission, acting in collaboration with the Agency, and taking into consideration the views of interested parties, shall agree the final list and timetable."

- Amendment 33 aimed at making it obligatory for the committee to appoint a rapporteur for the assessment of a referral:

"Article 36, paragraph 2:

In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint independent experts to advise it on specific questions. When appointing such experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks."

- Amendment 34 aimed at providing a time limit for oral or written explanations by the applicant or marketing authorisation holder in the case of referrals made in accordance with Articles 33 or 34:

"Article 36, paragraph 3, first subparagraph:

Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit which it will specify."

- Amendment 35 aimed at shortening the time limit for the decision making process. In order to align the wording with amendment 70 proposed by the European Parliament to amend Article 33 of Directive 2001/83/EC for medicinal products for human use, accepted by the Commission, which is aimed at reducing the corresponding time limit for the Commission to prepare a draft decision from 30 to 15 days, that same amendment is also introduced in Article 37, first subparagraph:

"Article 36, paragraph 5, first subparagraph:

Within 15 days of its adoption, the Agency shall forward the final opinion of the Committee to the Member States, the Commission and the applicant or the marketing authorisation holder together with a report describing the assessment of the veterinary medicinal product and the reasons for its conclusions.

Article 37, first subparagraph:

Within 15 days of receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law."

- Amendment 39 aimed at specifying the order of the items to be mentioned in the package leaflet:

"Article 61, paragraph 2, introductory wording:

The package leaflet shall be approved by the competent authorities. It shall contain, in the order indicated, at least the following information, which shall conform to the particulars and documents provided pursuant to Articles 12 to 13d and the approved summary of product characteristics:"

- Amendment 46 aimed at specifying that inspections can be carried out without prior notification. Alignment with the corresponding amendment 125 proposed by the European Parliament to amend Article 111 of Directive 2001/83/EC for medicinal products for human use, accepted by the Commission:

"Article 80, paragraph 1, subparagraph 2:

The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and of the premises of the marketing authorisation holder whenever it considers that there are serious grounds for suspecting non-compliance with the provisions of Article 51. Such inspections may also be carried out at the request of another Member State, the Commission or the Agency."

- Amendment 49 aimed at the publication of the rule of procedure of the Standing Committee for veterinary medicinal products:

"Article 89, paragraph 5:

The Standing Committee shall adopt its own rules of procedure, which shall be made public."

3.2. Amendments accepted in part or in principle by the Commission: 4, 5, 8, 9, 11, 14, 18, 26, 32, 36, 41, 42, 43, 48, 52, 53, 57, 58, 65, 68.

Certain provisions other than those targeted by the amendments accepted in principle have been reformulated to take account of faulty cross-references, alignment with the corresponding provisions for medicinal products for human use and linguistic corrections.

- The Commission can accept in principle amendments 4 and 41 aimed at providing a precision of the definition of a homeopathic veterinary medicinal product and its identification:

"Article 1, point 8:

Homeopathic veterinary medicinal product

Any veterinary medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States.

A homeopathic veterinary medicinal product may contain a number of active principles.

Article 64, paragraph 2, indent 1:

- the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used in accordance with point (8) of Article 1; if the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks may be supplemented on the labelling by an invented name,"

- The Commission can accept in principle amendment 5 aimed at providing a precision of the definition of the risks with the use of veterinary medicinal products and the benefit/risk ratio:

"Article 1, points 19, 19a and 19b:

(19) Risks related to the use of the product:

- any risk relating to the quality, safety and efficacy of the veterinary medicinal product as regards animal or human health;

(19a) Risks related to the environment:

- any risk of unwanted effects on the environment;

(19b) Benefit/risk ratio:

An evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risks as defined above."

- The Commission can accept in principle amendments 8 and 9 aimed at strengthening the exceptional nature of the use of veterinary medicinal products outside the authorised use for non-food producing species in a Member State, while allowing for the possibility to have access to such products authorised in other Member States. However, a rewording is necessary, as veterinary medicinal products are authorised for an animal species. In exceptional circumstances, for a non food-producing species, if a product is authorised in another country, free import/export of veterinary medicinal products by veterinarians could be possible if the Member States have put in place appropriate measures for the import and control of such products:

"Article 10, paragraph 1:

If there is no authorised medicinal product in a Member State for a condition affecting a non food-producing species, the veterinarian may, by way of exception, particularly in order to avoid causing unacceptable suffering to the animal concerned, under his/her personal responsibility, treat the animal(s) with:

(a) a veterinary medicinal product authorised in the Member State concerned under this Directive or under Regulation (EC) No .../.... [laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Medicinal Products Agency] for use with another animal species, or for another condition in the same species; or

(b) if there is no product as referred to in point (a),

(i) either a medicinal product authorised for human use in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council* or under Regulation (EC) No .../.... [laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Medicinal Products Agency]; or

(ii) a veterinary medicinal product authorised in another Member State in accordance with this Directive for use in the same species for the condition in question or for another condition. Member States shall take specific measures to control such use; or

(c) if there is no product as referred to in point (b) and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription.

* OJ L 311, 28.11.2001, p.67.

Article 10, paragraph 2:

By way of derogation from Article 11, the provisions of paragraph 1 shall also apply to the treatment by a veterinarian of an animal belonging to the equidae family provided that it has been declared, under Commission Decision 93/623/EEC* and Commission Decision 2000/68/EC**, as never having been intended for the production of foodstuffs.

Article 10, paragraph 3:

By way of derogation from Article 11, and in accordance with the procedure referred to in Article 89(2), the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Decision 93/623/EEC* and Commission Decision 2000/68/EC**.

* OJ L 298, 3. 12. 1993, p. 45, ** OJ L 23, 28.1.2000, p. 72."

- The Commission can accept in part amendment 11 aimed at providing a precision of the exceptional circumstances under which the use of veterinary medicinal products outside the authorised use for food producing species in a Member State is permitted, while allowing for the possibility to have access to such products authorised in other Member States. However, a rewording is necessary, as veterinary medicinal products are authorised for an animal species. In addition, Member States are obliged to control any import/export of veterinary medicinal products by veterinarians. Alignment with the corresponding text in Article 10 should also be reintroduced. Furthermore, the qualification by means of suitability of veterinary medicinal products is subjective, and such wording, can not be introduced in Community legislation:

"Article 11, paragraph 1:

By way of exception, if there is no authorised medicinal product in a Member State for a condition affecting a food-producing species, the veterinarian responsible may under his/her personal responsibility, in particular to avoid unacceptable suffering, treat the animals concerned on a particular holding with:

(a) a veterinary medicinal product authorised in the Member State concerned under this Directive or under Regulation (EC) No .../.... [laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Medicinal Products Agency] for use with another animal species, or for another condition in the same species; or

(b) if there is no product as referred to in point (a),

(i) either, a medicinal product authorised for human use in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No .../.... [laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Medicinal Products Agency]; or

(ii) a veterinary medicinal product authorised in another Member State in accordance with this Directive for use in the same species for the condition in question or for another condition. Member States shall take specific measures to control such use; or

(c) if the product or products as referred to in point (b) is/are not available and within the limits of the law of the Member State concerned, of a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription."

- The Commission can accept in principle amendments 14 and 68 aimed at adding a requirement to supply information in the application dossier on the pharmacovigilance system intended for a veterinary medicinal product and specific tests relating to the potential environmental risks posed by the veterinary medicinal product. However, sophisticated pharmacovigilance management systems are not necessary for all veterinary medicinal products and the requirement should therefore be required only where appropriate. Furthermore, the tests required to assess the potential risks to the environment are already included under the item safety tests. However, the provision relating to the potential environmental risks that the veterinary medicinal product may pose may be reformulated to take account of amendment 5:

"Article12, paragraph 3, point g:

Reasons for any precautionary and safety measures to be taken for the storage of the veterinary medicinal product, its administration to animals and for the disposal of waste products, together with an indication of any potential risks presented by the veterinary medicinal product for the environment and the health of humans, animals or plants;

Article12, paragraph 3, point ja:

A detailed description of the pharmacovigilance system and, where appropriate, the risk management system, which the applicant will introduce;"

- The Commission can accept in part amendment 18 aimed at providing an extension of the period allowed for development of products for use in additional food-producing species, from three to five years, with the view of making use of an extended period of exclusivity. However, the extension of the exclusivity period to new significant therapeutic indications and non-food producing species can not be accepted, as this would be counterproductive to the aim of the provision, namely provide an incentive for products for an extended number of minor food producing species, which are at the core of the problem with availability of veterinary medicines:

"Article 13, paragraph 4:

In the case of veterinary medicinal products intended for one or more food producing species and containing a new active substance that has not been authorised in the Community by [date] the ten-year period provided for in the first subparagraph of paragraph 1 shall be extended by one year for each extension of the marketing authorisation to another food producing species if it is authorised within the five years following the granting of the initial marketing authorisation.

This period cannot, however, exceed a total of 13 years, for a marketing authorisation for four or more species.

The extension of the ten-year period to 11, 12, or 13 years for a food-producing species shall be granted only if the marketing authorisation holder had also been at the origin of the maximum residue limits established for the species covered by the authorisation."

- The Commission can accept in principle amendment 26 aimed at providing for a way to make information on marketing authorisations available to the general public. A rewording is however necessary as neither the marketing authorisation nor the summary of product characteristics contain any confidential information the publication of which the marketing authorisation holder can contest. In addition, the Commission proposes to modify the provisions in line with the corresponding amendments 51 and 52 and the first part of amendment 53 proposed by the European Parliament to amend Article 21, paragraph 3 and second subparagraph of paragraph 4 of Directive 2001/83/EC for medicinal products for human use, accepted in principle by the Commission:

"Article 25, paragraph 3:

The competent authority shall make publicly available without delay a copy of the marketing authorisation together with the summary of product characteristics for each veterinary medicinal product, which it has authorised.

Article 25, paragraph 4, second subparagraph:

The competent authority shall make publicly accessible without delay the assessment report together with the reasons for its opinion after deleting any information of commercially confidential nature."

- The Commission can accept in principle amendment 32 aimed at providing for an obligatory referral of cases of risks to human or animal health or the environment where a Community interest is involved to allow for a scientific assessment of the question at Community level. However, to give full effect to such an obligatory referral it is necessary to clarify that such referral leads to a scientific opinion followed by a Commission decision as foreseen in Articles 37 and 38. For reasons of coherence, this similar clarification has to be introduced in the two other provisions on referral procedures. The referral procedure under Article 35 envisages inter alia changes of the marketing authorisation in order to take account of pharmacovigilance information. If this procedure is to be reinforced, Article 83 needs to be aligned so as to allow the competent authorities to take all necessary decisions, including, alongside the suspension and revocation, the variation of a marketing authorisation:

"Article 33, paragraph 3:

If within the period of 60 days the Member States fail to reach an agreement, the Agency shall be immediately informed with a view to application of the procedure laid down in Article 36, 37 and 38. The Agency shall be provided with a detailed description of the matters on which agreement could not be reached and the reasons for the disagreement. The applicant shall be provided with a copy of this information.

Article 34, paragraph 1:

If two or more applications submitted in accordance with Articles 12 to 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or withdrawal of authorisation, a Member State, or the Commission, or the marketing-authorisation holder may refer the matter to the Agency for application of the procedure laid down in Article 36, 37 and 38.

Article 35, paragraph 1, subparagraph 1:

The Member States or the Commission or the applicant or holder of the marketing authorisation shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Article 36, 37 and 38 before reaching a decision on a request for a marketing authorisation or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appear necessary, so as to take account in particular of the information collected in accordance with Title VII.

Article 83, paragraph 1, introductory wording:

The competent authorities of the Member States shall suspend, revoke or vary marketing authorisation when it is clear that:

Article 83, paragraph 2, introductory wording:

Authorisation shall be suspended, revoked or varied where it is established that: "

- The Commission can accept in principle amendment 36 aimed at providing for the transfer of the future report on the functioning of the proposed decentralised system for authorisation of veterinary medicinal products to the European Parliament. However, the Council will also receive this report and should thus be added to the provision:

"Article 42, paragraph 2:

The Commission shall publish, no later than [date], a report on experience gained on the basis of the procedures provided for in this chapter and shall propose any amendments necessary to improve the procedures. This report shall be forwarded to the European Parliament and the Council."

- The Commission can accept in principle amendments 42 and 43 aimed at providing for a possibility to minimise the prescribed amount of medicines to the actual need in certain cases and provisions for the dispensing of veterinary medicinal products authorised for food producing species, for which a precision is needed. However, the placement of the provisions of amendment 42 on prescriptions is incongruent with the provisions of Article 66 dealing with sales of medicines and is better placed in Article 67, as an additonal subparagraph, and vice versa for amendment 43, which should be placed in Article 66 relating to the dispensing of veterinary medicinal products. Furthermore, there is a need to limit the dispensing rights by other professions than veterinarians and pharmacists as concerns treatments of bacterial infections:

"Article 66, paragraph 2a:

Member States may permit on their territory the dispensing of veterinary medicinal products for food producing animals, for which a veterinary prescription is required, by or under the supervision of a registered person providing guarantees with respect to qualifications, record-keeping and reporting as appropriate in accordance with national legislation. The Member States shall notify this arrangement to the Commission. This provision shall not apply to the dispensing of veterinary medicinal products for the oral or parenteral treatment of bacterial infections.

Article 67, paragraph 1, point (d):

officinal formulae, as defined in Article 3(2)(b), intended for food-producing animals

Article 67, paragraph 1, second and third subparagraphs:

Member States shall take all necessary measures to ensure that, where medicinal products are supplied solely on prescription, the quantity prescribed and supplied shall be restricted to the minimum amount required for the treatment or therapy concerned.

In addition, a prescription shall be required for new veterinary medicinal products containing an active substance which has been authorised for use in a veterinary medicinal product for less than seven years."

- The Commission can accept in principle amendment 48 as far as the second part is concerned, aimed at prohibiting the direct advertising to the general public of veterinary medicinal products containing psychotropic or narcotic substances. These substances have a very specific status according to international law. However the first part of the amendment on the prohibition of advertising to the public of veterinary medicinal products available only after a veterinary prescription is not accepted, as it ignores that there is at present no general Community legislation on advertising of veterinary medicinal products on which such measures could be based:

"Article 85, paragraph 2a:

Member States shall prohibit the advertising to the general public of veterinary medicinal products which contain psychotropic or narcotic substances, such as those covered by the United Nations Conventions of 1961 and 1971."

- The Commission can accept in principle amendments 52 and 53 aimed at allowing for the use of homeopathic veterinary medicinal products in exceptional circumstances where there is no authorised veterinary medicinal product for the treatment of a particular condition. The proposed provision for non-food producing animals is in line with the possibility to use medicinal products for human use in exceptional circumstances, and should therefore be aligned with that provision. However, the provision aimed at introducing the possibility for extra-label use of homeopathic veterinary medicinal products for food-producing animals is acceptable only if appropriately controlled by the competent authorities. The recording of all treatments for food producing animals is furthermore necessary under other Community legislation and has therefore to be maintained. The provision should be amended in this sense:

"Article 16, paragraph 2a:

By way of derogation from Article 10, homeopathic veterinary medicinal products may be administered to non-food producing animals under the responsibility of a veterinarian.

Article 16, paragraph 2b:

By way of derogation from Article 11(1) and 11(2), Member States shall permit administration of homeopathic veterinary medicinal products intended for food producing species for which the active constituents are included in Annex II of Council Regulation (EEC) No 2377/90 under the responsibility of a veterinarian. Member States shall take appropriate measures to control the use of veterinary homeopathic medicinal products registered or authorised in another Member State in accordance with this Directive for use in the same species."

- The Commission can accept in principle amendments 57 and 58 aimed at changing the period of validity of the marketing authorisation. In effect the European Parliament proposes to amend the Commission's proposal which aims to remove the requirement to renew the authorisation after 5 years. The European Parliament proposes to introduce a requirement to renew the authorisation five years after the first marketing authorisation. After this first renewal, the authorisation will be considered as valid for an unlimited period. Recital 13 and Article 28, paragraph 1, are therefore amended. A rewording is necessary, however, to specify better the context of the first evaluation as well as to avoid adding time limits for such a procedure.

"Recital 13:

Marketing authorisation for new veterinary medicinal products should be limited initially to five years. After this first renewal, the marketing authorisation shall be considered as valid for an unlimited period. Furthermore, any authorisation not used for three consecutive years, that is to say, one which has not led to the placing on the market of a medicinal product in the Community during that period, should be considered invalid, in order, in particular, to avoid the administrative burden linked to maintaining such authorisations.

Article 28, paragraph 1:

Without prejudice to paragraphs 2 and 3, the marketing authorisation shall be valid for five years.

This authorisation may be renewed after five years on the basis of a reassessment of benefit/risk ratio. When, after five years, the marketing authorisation is renewed, the holder shall submit a consolidated dossier on the quality, safety and efficacy of the veterinary medicinal product with all the variations introduced during the five years of validity. The application for renewal shall be submitted at least six months prior to the date of expiry of the authorisation.

After this renewal, the marketing authorisation shall be valid for an unlimited duration."

- The Commission can accept in principle amendment 65 aimed at allowing for a derogation from the need for established maximum residue limits for pharmacologically active substances in veterinary medicinal products for the Equidae species, provided the target species is limited to those animals never having been intended to be used for the production of food-stuffs. However, it is not acceptable to allow this exemption for active substances to be included in veterinary medicinal products, for which alternative products are available. Likewise it is not acceptable to allow for marketing authorisations of products which contain substances included in Annex IV of Regulation (EEC) No 2377/90, as this would preclude the possibility to restrict import of foodstuffs containing such substances from third countries. Therefore, the provision has to be restricted and reworded as follows and a clarifying paragraph added to Article 12 dealing with the application for marketing authorisation:

"Article 6, paragraph 3:

By way of derogation from paragraph 1, a veterinary medicinal product containing pharmacologically active substances not included in Annexes I, II or III of Regulation (EEC) No 2377/90 may be authorised for the particular animals of the Equidae species, which have been declared, under Commission Decision 93/623/EEC* and Commission Decision 2000/68/EC**, as never having been intended for the production of foodstuffs. The active substances of such veterinary medicinal products shall not be included in Annex IV of Council Regulation (EEC) No 2377/90 or intended for use in the treatment of conditions for which a veterinary medicinal product is authorised in the Community.

Article 12, paragraph 1, third subparagraph:

In the case of veterinary medicinal products referred to in Article 6(3), a marketing authorisation may be applied for without a valid application in accordance with Regulation (EEC) No 2377/90. All scientific documentation necessary for the demonstration of the quality, safety and efficacy according to paragraph 3 shall be submitted."

- The Commission proposes to modify Article 1, point 2(b), to clarify the definition of a veterinary medicinal product by making reference to pharmacological, immunological and metabolic action. This modification is in line with amendment 11 proposed by the European Parliament to amend Article 1, point 2b, of Directive 2001/83/EC for medicinal products for human use, which has been accepted in principle by the Commission:

"Article 1, point 2(b):

which may be administered to or used in animals either with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action."

- The Commission proposes to introduce a definition of the local representative in Article 1, point 17a. This modification is in line with the wording of amendment 14 proposed by the European Parliament of Directive 2001/83/EC for medicinal products for human use which has been accepted in principle by the Commission:

"Article 1, point 17a:

Representative of the marketing authorisation holder:

The person, commonly known as local representative, designated by the marketing authorisation holder to represent him/her in the Member State concerned. Any delegation of activities to this person by the marketing authorisation holder shall not relieve the latter of his/her legal responsibility."

- The Commission proposes to modify Article 12, paragraph 3, point c, in line with the corresponding amendment 25 proposed by the European Parliament to amend Article 10, paragraph 1 of Directive 2001/83/EC for medicinal products for human use, accepted by the Commission. This amendment regards information to be submitted by the applicant the on constituents of the medicinal product:

"Article 12, paragraph 3, point c:

Qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including the reference to its international non-proprietary name (INN) recognised by the WHO, where an INN name exists, or a reference to the relevant chemical name;"

- The Commission proposes to modify Article 13, paragraph 1, and to add a subparagraph between the first and second subparagraphs, in line with the corresponding amendment 36 proposed by the European Parliament to amend Article 10, paragraph 1 of Directive 2001/83/EC for medicinal products for human use, accepted in principle by the Commission. This amendment would allow for an abridged application for a generic product in a Member State even if the reference product has not been authorised in that particular Member State, but only in another Member State:

"Article 13, paragraph 1, second subparagraph:

The first subparagraph shall also apply, if the reference medicinal product has not been authorised in the Member State where the application for the generic medicinal product is submitted. In this case, the applicant has to indicate in the application the name of the Member State where the reference medicinal product is or has been authorised. On request of the competent authority of the Member State where the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a copy of the dossier and of the marketing authorisation of the reference medicinal product."

- The Commission proposes to modify Article 13, paragraph 2, point (b), aimed at providing a more precise definition of a generic medicinal product, in line with the scientific definition informally accepted by the Member States. The proposal is in coherence with amendment 156 proposed by the European Parliament to amend Article 10, paragraph 2 of Directive 2001/83/EC for medicinal products for human use, which the Commission accepted in principle, subject to reformulation to take account of the existing definition:

"Article 13, paragraph 2, point (b):

generic medicinal product shall mean a medicinal product which has the same qualitative and quantitative composition in terms of active substances, the same pharmaceutical form, and whose bioequivalence with the reference medicinal product has been demonstrated by means of appropriate bioavailability tests. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered as the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. Bioavailability tests may not be required of the applicant if he/she can demonstrate that the medicinal product meets the criteria set out in Annex I."

- The Commission proposes a new paragraph 3a in Article 13 to specify the documentation requirements for biological generic veterinary medicinal products. These medicinal products can not always be classified as generic medicinal products in the sense of the definition provided for in Article 13, paragraph 2, point (b), but should not require the submission of a complete dossier in all cases. The documentation shall nevertheless include all necessary documents and particulars with respect to the safety tests and the preclinical and clinical trials to replace the bioavailability studies. The proposal is in coherence with amendments 167 and 168 proposed by the European Parliament to amend Article 10 of Directive 2001/83/EC for medicinal products for human use, which the Commission accepted in principle, subject to reformulation as indicated above, by the introduction of a separate paragraph:

"Article 13, paragraph 3a:

In the case that a biological veterinary medicinal product similar to a reference biological veterinary medicinal product does not fulfil all the conditions of the definition of generic medicinal product, the results of appropriate pre-clinical and clinical trials linked to these conditions shall be submitted. The results of other tests, referred to in the dossier of the reference medicinal product, are not required to be submitted."

- The Commission proposes to modify Article 23, paragraph 3, to provide for correct reference to Article 12:

"Article 23, paragraph 3:

may similarly check, in particular through consultation of a national or Community reference laboratory, that the analytical method used for detecting residues presented by the applicant in accordance with point (j) of Article 12(3) is satisfactory;"

- The Commission proposes to modify Article 30, subparagraph 4, to align the wording with the corresponding amendment 60 proposed by the European Parliament to amend Article 26 of Directive 2001/83/EC for medicinal products for human use, accepted by the Commission subject to rewording, to introduce the explicit responsibility of the applicant or marketing authorisation holder for the correctness of data submitted in support of an application for marketing authorisation:

"Article 30, subparagraph 4:

The applicant or marketing authorisation holder is responsible for the veracity of the documents and the data submitted by him/her.

- The Commission proposes to modify Article 33, paragraph 1, to add a paragraph 1a aimed at the introduction of a provision to clarify the notion of a potential serious risk to human or animal health or the environment. This modification is in line with the corresponding amendment 63 proposed by the European Parliament to amend Article 29 of Directive 2001/83/EC for medicinal products for human use, which the Commission accepted subject to rewording to take account of the need for any guidance proposed to be adopted by the Commission:

"Article 33, paragraph 1a:

Guidelines to be adopted by the Commission shall define a serious risk to human or animal health or the environment."

- The Commission proposes to modify Article 58, paragraph 1, point (a) and Article 61, paragraph 2, points (a) and (b) to be in line with the corresponding proposal to amend Directive 2001/83/EC for medicinal products for human use. It is also proposed to modify Article 61, paragraph 1 by adding a second subparagraph, for reasons of coherence with the corresponding amendment 86 proposed by the European Parliament to amend Article 63 of Directive 2001/83/EC for medicinal products for human use, to allow for the inclusion of information in several languages on the same package leaflet, provided the information in all the languages is identical:

"Article 58, paragraph 1, point (a):

the name of the medicinal product followed by its strength and pharmaceutical form, if the medicinal product is available in several strengths and/or pharmaceutical forms; the common name shall be included where the product contains only one active substance and if its name is an invented name;

Article 61, paragraph 1:

The inclusion of a package leaflet in the packaging of veterinary medicinal products shall be obligatory unless all the information required by this Article can be conveyed on the immediate packaging and the outer packaging. Member States shall take all appropriate measures to ensure that the package leaflet relates solely to the veterinary medicinal product with which it is included. The package leaflet shall be worded in terms that are comprehensible to the general public and in the official language or languages of the Member State in which the medicinal product is marketed.

The provisions of the first subparagraph do not preclude the possibility that the package leaflet is written in several languages, on condition that the information is identical in all the languages.

Article 61, paragraph 2, point (a):

name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where appropriate, of the local representative designated by the marketing authorisation holder in the Member State;

Article 61, paragraph 2, point (b)

name of the veterinary medicinal product followed by its strength and pharmaceutical form. The common name shall be included where the product contains only one active substance and if its name is an invented name. Where the medicinal product is authorised according to the procedure provided for in Articles 31 to 43 under different names in the Member States concerned, a list of the names authorised in each Member State;"

- The Commission proposes to modify Articles 64, paragraph 2, to be coherent with the requirement in Article 17, paragraph 1, point (b), that no specific therapeutic indication may appear either on the labelling or on any information relating to the homeopathic veterinary medicinal product and to align the wording with the corresponding amendment 89 proposed by the European Parliament to amend Article 68 of Directive 2001/83/EC for medicinal products for human use:

"Article 64, paragraph 2, introductory wording:

In addition to the clear mention of the words 'homeopathic veterinary medicinal product without approved therapeutic indications' and to the reference to the potentised nature of the product, the labelling and, where appropriate, package leaflet for the homeopathic veterinary medicinal products referred to in Article 17(1) shall bear the following information and no other information:"

- The Commission proposes to modify Article 72, paragraph 2, to make it obligatory for Member States to impose specific requirements to report adverse reactions to veterinary medicinal products. This modification is proposed to achieve coherence with amendment 114 on pharmacovigilance issues proposed by the European Parliament to amend Article 101 of Directive 2001/83/EC for medicinal products for human use, which have been accepted by the Commission subject to reformulation:

"Article 72, paragraph 2:

The Member States shall impose specific requirements on veterinary practitioners and other health care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions."

- The Commission proposes to modify Article 73, third paragraph, to clarify the provisions on public access to information on veterinary medicinal products. This modification is proposed to achieve coherence with amendment 116 on pharmacovigilance issues proposed by the European Parliament to amend Article 102 of Directive 2001/83/EC for medicinal products for human use, which have been accepted by the Commission subject to reformulation, to avoid reference to the data base but allowing the widest possible public access to the information:

"Article 73, third paragraph:

Member States shall ensure that appropriate information collected within this system is forwarded to the other Member States and the Agency. This information shall be recorded in the database referred to in point (j) of the second paragraph of Article 51 of Regulation (EEC) No 2309/93 and shall be permanently accessible to the public without delay."

- The Commission proposes to modify Article 75, paragraph 5, to clarify how to calculate when the periodic safety update reports have to be presented, and to add a new paragraph 7 on the communication of pharmacovigilance information by the marketing authorisation holder to the public. These modifications are proposed to achieve coherence with amendments 120 and 121 on pharmacovigilance issues proposed by the European Parliament to amend Article 104 of Directive 2001/83/EC for medicinal products for human use, which have been accepted by the Commission:

"Article 75, paragraph 5:

Unless other requirements have been laid down as a condition for the granting of authorisation, or subsequently as indicated in the guidance referred to in Article 77(1), records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows: six monthly for the first two years after the veterinary medicinal product was first placed on the market, annually for the subsequent two years, and thereafter at three-yearly intervals. The periodic safety update reports shall include a scientific evaluation of the benefits and risks of the veterinary medicinal product.

Article 75, paragraph 7:

The marketing authorisation holder shall not be authorised to communicate information on pharmacovigilance issues to the public without the consent of the competent authority."

- The Commission proposes to add a new Article 75a aimed at providing a requirement on the part of the marketing authorisation holder to inform the competent authorities of any cessation of the marketing of a veterinary medicinal product for reasons other than safety concerns. A time limit for the provision of such information should also be introduced. These modifications are proposed to achieve coherence with amendments 122 and 159 proposed by the European Parliament to amend the Directive 2001/83/EC, which have been accepted in principle by the Commission, subject to reformulation in line with the revised proposal to amend Regulation (EEC) No 2309/93:

"Article 75a:

The marketing authorisation holder shall also inform the competent authorities of any possible suspension, temporary or permanent, of the marketing of the veterinary medicinal product. This notification shall take place, unless there are exceptional circumstances, at least two months before the cessation of the marketing of the product."

- The Commission proposes to modify Article 84, paragraph 1, point (a), to reflect that the provisions of this article apply to already authorised veterinary medicinal products:

"Article 84, paragraph 1, point (a):

it is clear that the benefit/risk assessment of the veterinary medicinal product is, under the authorised conditions of use, unfavourable, particular regard being had to the benefits for animal health and welfare and to the safety and health benefits for the consumer, when the authorisation concerns a veterinary medicinal product for zootechnical use."

1.1. Amendments not accepted by the Commission: 2, 3, 7, 10, 13, 16, 17, 23, 25, 27, 30, 37, 38, 40, 44, 45, 47, 56, 59, 60, 62, 63, 64, 66, 67 and 69.

- The Commission cannot accept amendment 2 in recital 8 aimed at restricting authorisation of veterinary medicinal products for food producing animals to therapeutic purposes, as the prohibition of other uses is not within the scope of the legislation related to pharmaceutical products.

- The Commission cannot accept amendment 3 in a new recital aimed at a request by the European Parliament to the Commission to develop a standard environmental classification system for veterinary medicinal products. According to the Commission, this proposal is not necessary, as each new veterinary medicinal product is evaluated with respect to environmental risk assessment in the overall benefit/risk profile of that particular product. There is furthermore a problem with the availability of veterinary medicinal products which has to be underscored.

- The Commission cannot accept amendment 7 aimed at limiting the marketing authorisation of a veterinary medicinal product to a single pharmaceutical form. This change is not acceptable as the concept of an authorisation covers the original authorisation and any extensions to additional strengths, pharmaceutical forms and presentations. The addition of a pharmaceutical form is authorised in accordance with Regulation 541/95 on variations (implemented in accordance with Article 39).

- The Commission cannot accept amendment 10 aimed at allowing veterinarians unlimited access to treatment of all animals of the Equidae species, even with substances prohibited for use in food producing animals (annex IV). However, the provision is being modified to take account of the necessity to include Equidae for breeding and production within the scope of the provisions relating to Equidae excluded from production of foodstuffs in accordance with Commission Decision 2000/68/EC (see section 3.2. amendments 8 and 9).

- The Commission cannot accept amendment 13 aimed at providing a zero withdrawal period for all homeopathic veterinary medicinal products with a concentration of the active principle of equal or less than one part per million. This level of active principle is not referred to elsewhere in the Directive and even substances included in homeopathic veterinary medicinal products may be hazardous to human health.

- The Commission cannot accept amendment 16 aimed at limiting the data protection period for products containing new substances, not previously included in veterinary medicinal products in the European Union, to eight years. This amendment shifts the balance between protecting innovation and reinforcing generic competition which is included in the Commission proposal.

- The Commission cannot accept amendment 17 aimed at extending the period of data protection for veterinary medicinal products containing new active substances to 15 years for products for smaller species and laying hens if the applicants places the product on the market within two years of authorisation. A definition of a smaller species is not possible at Community level, as this will vary from region to region in the Community. Furthermore 15 years is too long in comparison with the Commission proposal of 10 years as a general period for data protection. The proposal of the Commission to extend the data protection period directly to 13 years for products for bees and fish was made because it is unlikely that such products can be used in other species. The same conditions cannot be applied to laying hens and other species. Furthermore, the proposal by the European Parliament to qualify the amendment by a clause on placing on the market will not provide any additional safeguard with respect to the availability of veterinary medicinal products.

- The Commission cannot accept amendment 23 aimed at allowing active substances of human or animal origin to be included in homeopathic veterinary medicinal products provided that they comply with the monograph on homeopathic preparations of the European pharmacopoeia. For such substances there are additional essential requirements to be complied with, such as absence of adventitious agents and a risk assessment with respect to TSE.

- The Commission cannot accept amendment 25 aimed at deleting requirements for safety tests for homeopathic veterinary medicinal products for food-producing species if the substance is included in Annex II of Regulation (EEC) No 2377/90. There is no scientific justification to deviate from the harmonised standards as contained in the Directive for testing of the safety and efficacy of homeopathic veterinary medicinal products for food-producing species.

- The Commission cannot accept amendment 27 aimed at adding a reference to Community law to the requirement on marketing authorisation holders after an authorisation has been issued. Marketing authorisation holders have in any case to abide by Community law.

- The Commission cannot accept amendment 30 aimed at making a referral obligatory in the cases where divergent decisions have been taken in respect of marketing authorisations. The reasons of taking divergent decisions can vary significantly and may not pose a risk to human or animal health or the environment. Hence, it is necessary in these situations to maintain the discretion foreseen in the current provisions.

- The Commission cannot accept amendment 37 aimed at providing a reference to containers and a space on the label of the medicinal product to provide for the possibility to write additional information. The definition chosen for the container is the immediate packaging, which is already in the text. The extra label space is not feasible for all products, as there may be a problem of space. If there is a need of extra information, it should be solved by other means to provide the information.

- The Commission cannot accept amendment 38 aimed at amending the wording related to specific precautions for the disposal of veterinary medicinal products and making it a requirement to return all unused medicinal product to the pharmacy. The first part of the proposed wording does not add anything to the provision as proposed by the Commission. The proposal to return all unused products to the pharmacy is not workable in practice, as veterinary medicinal products are also delivered by other distribution channels. Furthermore there is no harmonised distribution system for veterinary medicinal products in the Community.

- The Commission cannot accept amendment 40 aimed at introducing a reference to article 59 in article 64. Article 59 is not relevant for homeopathic veterinary medicinal products as all information relating to these products are listed in Article 64.

- The Commission cannot accept amendment 44 aimed at reducing the period for compulsory prescription only status for veterinary medicinal products containing new active substances to four years under certain circumstances. The need to strengthen the provisions of pharmacovigilance cannot be limited to the first four years after authorisation.

- The Commission cannot accept amendments 45 and 69 aimed at providing guarantees of independent funding of activities of the national authorities in the field of pharmacovigilance, as this is a question of national competence.

- The Commission cannot accept amendment 47 aimed at providing for a relative effectiveness assessment of a veterinary medicinal product. The risk /benefit ratio for one medicinal product is related to the authorisation of that specific product and not to other products.

- The Commission cannot accept amendment 56 aimed at introducing four new articles to impose on Member States certain criteria of independence, transparency and confidentiality to be applied in the framework of the scientific evaluation and authorisation of veterinary medicinal products. The Commission considers that pharmaceutical legislation provides for a framework for procedures for marketing authorisation, surveillance and control of medicinal products and not for internal administrative procedures in the national competent authorities.

- The Commission cannot accept amendment 59 aimed at introducing a derogation for the application of Regulation (EEC) No 2377/90 on maximum residue limits (MRLs), to allow veterinarians, in exceptional circumstances, to treat food-producing animals with medicinal products containing substances not included in Annex I, II, or III of that Regulation, provided that he/she specifies a withdrawal period. The Commission considers that this derogation would have serious implications for consumer safety and for the future of the veterinary pharmaceutical industry, if veterinarians were given the possiblity to use any medicinal product in any species. No residue control possibilities would exist for such use and the incentive for the pharmaceutical industry to develop new products would be diminished. The veterinarian would furthermore not have sufficient information to establish a withdrawal period, as these are based on the preexistence of MRLs for at least one food-producing species.

- The Commission cannot accept amendment 60 aimed at introducing a definition of food-producing animals in the Directive. The Commission considers that such a definition does not fall within the scope of the pharmaceutical legislation.

- The Commission cannot accept amendment 62 aimed at introducing a reference in Article 11 to the absence of validated scientific data, as a prerequisite for the application of administrative withdrawal periods. The Commission considers that such reference is superflouous to the contents of the paragraph, which gives a minimum administrative withdrawal period that shall always be respected when the provisions of this Article are applied.

- The Commission cannot accept amendments 63 and 66 aimed at introducing a change in the provisions concerning the possibilities of the Member States to control the use of veterinary medicinal products intended for food-producing animals but not authorised in the Member State. The Commission considers that it is of paramount importance that a national control system is put in place. The importation of veterinary medicinal products from other Member States have to be strictly controlled by the authorities, as the entire marketing authorisation system would otherwise be undermined.

- The Commission cannot accept amendment 64 aimed at introducing a new recital on freedom of choosing an alternative therapy, despite differences in legal status of such therapies in Member States. The Commission considers that such a recital does not correspond to any provision of the proposal and thus, cannot be included in the proposal.

- The Commission cannot accept amendment 67 aimed at introducing a new definition of a veterinary prescription to allow only authorised veterinarians to prescribe medicinal products for use in animals. The Commission considers that this definition is too detailed and restricted. It may be envisaged that other authorised professionals may be allowed to prescribe particular types of medicinal products under national law. Furthermore, the meaning of representative samples and good veterinary practice in this context is unclear.

2. Modified proposal

In conformity with Article 250, paragraph 2, of the EC treaty, the Commission has modified its proposal along the lines indicated.