Source: EURLEX
Language: en
Format: md

**EUROPEAN UNION**

**THE EUROPEAN PARLIAMENT** **THE COUNCIL**

**Brussels, 2 May 2019**
**(OR. en)**

**2018/0161 (COD)** **PE-CONS 52/19**

**PI 34**

**COMPET 146**

**PHARM 9**

**IA 65**

**CODEC 440**

**LEGISLATIVE ACTS AND OTHER INSTRUMENTS**

Subject: REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL amending Regulation (EC) No 469/2009 concerning the
supplementary protection certificate for medicinal products

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**REGULATION (EU) 2019/…**

**OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**of …**

**amending Regulation (EC) No 469/2009 concerning**

**the supplementary protection certificate for medicinal products**

**(Text with EEA relevance)**

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114

thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee **[1]**,

Acting in accordance with the ordinary legislative procedure **[2]**,

**1** OJ C 440, 6.12.2018, p. 100.
**2** Position of the European Parliament of 17 April 2019 [(OJ …)/(not yet published in the
Official Journal)] and decision of the Council of ….

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Whereas:

(1) Regulation (EC) No 469/2009 of the European Parliament and of the Council **[1]** provides

that any product protected by a patent in the territory of a Member State and subject, prior

to being placed on the market as a medicinal product, to an administrative authorisation

procedure as laid down in Directive 2001/82/EC **[2]** or 2001/83/EC **[3]** of the

European Parliament and of the Council, may, under the terms and conditions provided for

in that Regulation, be the subject of a supplementary protection certificate (‘certificate’).

(2) By providing for a period of supplementary protection, Regulation (EC) No 469/2009

seeks to promote, within the Union, the research and innovation that is necessary to

develop medicinal products, and to contribute to preventing the relocation of

pharmaceutical research outside the Union to countries that might offer greater protection.

**1** Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009
concerning the supplementary protection certificate for medicinal products (OJ L 152,
16.6.2009, p. 1).
**2** Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001
on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001,
p. 1). Directive 2001/82/EC is repealed and replaced, with effect from 28 January 2022, by
Regulation (EU) 2019/6 of the European Parliament and of the Council of
11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
(OJ L 4, 7.1.2019, p. 43).
**3** 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 (OJ L 311,
28.11.2001, p.67).

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(3) Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets

have evolved significantly and there has been huge growth in the making of generics and

especially of biosimilars, and in the making of their active ingredients, in particular in

countries outside the Union (‘third countries’) in which protection does not exist or has

expired.

(4) The absence in Regulation (EC) No 469/2009 of any exception to the protection conferred

by the certificate has had the unintended consequence of preventing makers of generics

and biosimilars established in the Union from making generics and biosimilars in the

Union, even for the purpose of export to third-country markets in which protection does

not exist or has expired. Likewise, makers are prevented from making generics and

biosimilars for the purpose of storing them for a limited period before the expiry of the

certificate. Those circumstances make it more difficult for those makers, in contrast to

makers located in third countries where protection does not exist or has expired, to enter

the Union market immediately after expiry of the certificate, given that they are not in a

position to build up production capacity for the purpose of export or for the purpose of

entering the market of a Member State until the protection provided by that certificate has

expired.

(5) Those circumstances put makers of generics and biosimilars established in the Union at a

significant competitive disadvantage in comparison with makers based in third countries

that offer less or no protection. The Union should strike a balance between restoring a level

playing field between those makers and ensuring that the essence of the exclusive rights of

holders of certificates (‘certificate holders’) is guaranteed in relation to the Union market.

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(6) Without intervention, the viability of makers of generics and biosimilars established in the

Union could be threatened, with consequences for the Union’s pharmaceutical industrial

base as a whole. That situation could affect the fully effective functioning of the internal

market through the loss of potential new business opportunities for makers of generics and

biosimilars, thereby possibly diminishing related investments and hampering job creation

within the Union.

(7) The timely entry of generics and biosimilars into the Union market is important,

particularly in order to increase competition, to reduce prices and to ensure that national

healthcare systems are sustainable and that patients in the Union have better access to

affordable medicines. The importance of such timely entry was underlined by the Council

in its conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical

systems in the Union and its Member States. Regulation (EC) No 469/2009 should,

therefore, be amended so as to allow the making of generics and biosimilars for export and

storing, while bearing in mind that intellectual property rights remain one of the

cornerstones of innovation, competitiveness and growth in the internal market.

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(8) The aim of this Regulation is to promote the competitiveness of the Union, thereby

enhancing growth and job creation in the internal market and contributing to a wider

supply of products under uniform conditions, by allowing makers of generics and

biosimilars established in the Union to make in the Union products, or medicinal products

containing those products, for the purpose of export to third-country markets in which

protection does not exist or has expired, thereby also helping those makers to compete

effectively in those third-country markets. This Regulation should also allow such makers

to make and store products, or medicinal products containing those products, in a

Member State for a defined period pending the expiry of the certificate, for the purpose of

entering the market of any Member State upon expiry of the corresponding certificate,

thereby helping those makers to compete effectively in the Union immediately after

                         protection has expired (‘EU day one entry’). This Regulation should also complement the

efforts of the Union’s trade policy to ensure open markets for makers of products, or

medicinal products containing those products, established in the Union. Over time, this

Regulation should benefit the entire pharmaceutical sector in the Union, by allowing all

players, including newcomers, to reap the benefits of the new opportunities opening up in

the fast-changing global pharmaceutical market. Furthermore, the general interest of the

Union would be promoted given that, by reinforcing Union-based supply chains for

medicines and by allowing storing with a view to entry into the Union market upon expiry

of the certificate, medicines would become more accessible to patients in the Union after

the expiry of the certificate.

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(9) In those specific and limited circumstances, and in order to create a level playing field

between makers established in the Union and third-country makers, it is appropriate to

provide for an exception to the protection conferred by a certificate so as to allow the

making of a product, or a medicinal product containing that product, for the purpose of

export to third countries or of storing, and any related acts in the Union strictly necessary

for that making or for the actual export or the actual storing, where such acts would

otherwise require the consent of a certificate holder (‘related acts’). For instance, such

related acts could include: possessing; offering to supply; supplying; importing; using or

synthesising an active ingredient for the purpose of making a medicinal product; or

temporary storing or advertising for the exclusive purpose of export to third-country

destinations. That exception should also apply to related acts performed by third parties

who are in a contractual relationship with the maker.

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(10) The exception should apply to a product, or a medicinal product containing that product,

protected by a certificate. It should cover the making of the product protected by a

certificate in the territory of a Member State and the making of the medicinal product

containing that product.

(11) The exception should not cover placing a product, or a medicinal product containing that

product, which is made for the purpose of export to third countries or of storing with a

view to EU day-one entry, on the market of a Member State where a certificate is in force,

either directly or indirectly after export, nor should it cover re-importation of such a

product, or medicinal product containing that product, into the market of a Member State

in which a certificate is in force. Moreover, it should not cover any act or activity carried

out for the purpose of import of products, or medicinal products containing those products,

into the Union merely for the purposes of repackaging and re-exporting. In addition, the

exception should not cover any storing of products, or medicinal products containing those

products, for any purposes other than those set out in this Regulation.

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(12) By limiting the scope of the exception to making for the purpose of export outside the

Union or to making for the purpose of storing, and to acts strictly necessary for such

making or for the actual export or the actual storing, the exception provided for in this

Regulation should not conflict with the normal exploitation of the product, or the medicinal

product containing that product, in the Member State in which the certificate is in force,

namely with the core exclusive right of the certificate holder to make that product for the

purpose of placing it on the Union market during the term of the certificate. In addition,

that exception should not unreasonably prejudice the legitimate interests of the certificate

holder, whilst taking account of the legitimate interests of third parties.

(13) Effective and proportionate safeguards should apply in relation to the exception in order to

increase transparency, to help the holder of a certificate enforce its protection in the Union

and check compliance with the conditions set out in this Regulation, and to reduce the risk

of illicit diversion onto the Union market during the term of the certificate.

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(14) This Regulation should impose an information obligation on the maker, namely the person

established in the Union, on whose behalf the making of a product, or a medicinal product

containing that product, for the purpose of export or storing, is carried out. It is possible

that the maker directly carries out the making. That information obligation should consist

of requiring the maker to provide certain information to the competent industrial property

office, or another designated authority, which granted the certificate (‘the authority’) in the

Member State where the making is to take place. A standard form for notification should

be provided for this purpose. The information should be provided before the making of a

product, or a medicinal product containing that product, starts for the first time in that

Member State, or before any related act prior to that making, whichever is the earlier. The

information should be updated as and when appropriate. The making of a product, or a

medicinal product containing that product, and the related acts, including those performed

in Member States other than the one of making in cases where the product is also protected

by a certificate in those other Member States, should only fall within the scope of the

exception where the maker has sent the notification to the authority of the Member State of

making, and where the maker has informed the holder of the certificate granted in that

Member State. Where making takes place in more than one Member State, a notification

should be required in each of those Member States. In the interests of transparency, the

authority should be required to publish, as soon as possible, the information received,

together with the date of notification of that information. Member States should be allowed

to require that notifications, and updates to notifications, be subject to the payment of a

one-off fee. That fee should be set at a level which does not exceed the administrative cost

of processing notifications and updates.

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(15) The maker should also inform the certificate holder, through appropriate and documented

means, of the intention to make a product, or a medicinal product containing that product,

pursuant to the exception, by providing the certificate holder with the same information as

notified to the authority. That information should be limited to what is necessary and

appropriate for the certificate holder to assess whether the rights conferred by the

certificate are being respected, and should not include confidential or commercially

sensitive information. The standard form for notification could also be used to inform the

certificate holder, and the information provided should be updated as and when

appropriate.

(16) With regard to related acts, if any, prior to the making of a product, or a medicinal product

containing that product, the notification should indicate the name of the Member State in

which the first related act which would otherwise require the consent of a certificate holder

is to take place, as that information is relevant for the timing of the notification.

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(17) If a local marketing authorisation, or the equivalent of such authorisation, in a specific

third country, for a given medicinal product, is published after the authority is notified, the

notification should be promptly updated to include the reference number of that marketing

authorisation, or the equivalent of such authorisation, as soon as it is publicly available. If

the reference number of that marketing authorisation, or the equivalent of such

authorisation, is pending publication, the maker should be required to provide, in the

notification, that reference number as soon as it is publicly available.

(18) For reasons of proportionality, failure to comply with the requirement regarding a third

country should only affect exports to that country, and exports to that country should thus

not benefit from the exception provided for in this Regulation. It should be the

responsibility of the maker established in the Union to verify that protection does not exist

or has expired in a country of export, or whether that protection is subject to any

limitations or exemptions in that country.

(19) A notification to the authority and the corresponding information to the certificate holder

could be provided during the period between the date of entry into force of this Regulation

and the date on which the exception provided for in this Regulation becomes applicable for

the relevant certificate.

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(20) This Regulation should impose certain due diligence requirements on the maker as a

condition to use the exception. The maker should be required to inform persons within its

supply chain in the Union, including the exporter and the person carrying out the storing,

through appropriate and documented means, in particular contractual means, that the

product, or the medicinal product containing that product, is covered by the exception

provided for in this Regulation and that the making is intended for the purpose of export or

storing. A maker who fails to comply with those due diligence requirements should not

benefit from the exception, nor should any third party performing a related act in the

Member State of making or in a different Member State in which a certificate conferring

protection for the product is in force. The holder of the relevant certificate would therefore

be entitled to enforce its rights under the certificate, while having due regard to the general

obligation, provided for in Directive 2004/48/EC of the European Parliament and of the

Council **[1]**, not to engage in abusive litigation.

**1** Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on
the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).

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(21) This Regulation should impose labelling requirements on the maker in respect of products,

or medicinal products containing those products, to be exported, in order to facilitate, by

means of a logo, identification of such products or such medicinal products as being

exclusively intended for the purpose of export to third countries. Making for the purpose of

export and related acts should only fall within the scope of the exception if the product, or

the medicinal product containing that product, is labelled in the manner provided for in this

Regulation. That labelling obligation should be without prejudice to labelling requirements

of third countries.

(22) Any act not covered by the exception provided for in this Regulation should remain within

the scope of the protection conferred by a certificate. Any diversion onto the Union market,

during the term of the certificate, of any product, or any medicinal product containing that

product, made under the exception, should remain prohibited.

(23) This Regulation is without prejudice to other intellectual property rights that could protect

other aspects of a product, or a medicinal product containing that product. This Regulation

does not affect the application of Union acts that aim to prevent infringements, and

facilitate enforcement, of intellectual property rights, including Directive 2004/48/EC and

Regulation (EU) No 608/2013 of the European Parliament and of the Council **[1]** .

**1** Regulation (EU) No 608/2013 of the European Parliament and of the Council of
12 June 2013 concerning customs enforcement of intellectual property rights and repealing
Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).

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(24) This Regulation does not affect the rules on the unique identifier, provided for in

Directive 2001/83/EC. The maker should ensure that any medicinal product made for the

purpose of export, pursuant to this Regulation, does not bear an active unique identifier

within the meaning of Commission Delegated Regulation (EU) 2016/161 **[1]** . However, under

that Delegated Regulation, the requirement to carry such an active unique identifier applies

to medicinal products intended to be placed on the market of a Member State upon expiry

of the corresponding certificate.

(25) This Regulation does not affect the application of Directives 2001/82/EC and 2001/83/EC,

in particular the requirements relating to the manufacturing authorisation of medicinal

products made for export. This includes compliance with the principles and guidelines of

good manufacturing practices for medicinal products and using only active substances

which have been manufactured in accordance with good manufacturing practices for active

substances and distributed in accordance with good distribution practices for active

substances.

**1** Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing
Directive 2001/83/EC of the European Parliament and of the Council by laying down
detailed rules for the safety features appearing on the packaging of medicinal products for
human use (OJ L 32, 9.2.2016, p. 1).

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(26) To safeguard the rights of certificate holders, the exception provided for in this Regulation

should not apply to a certificate that has already taken effect at the date of entry into force

of this Regulation. In order to ensure that the rights of certificate holders are not

excessively restricted, the exception should apply to certificates that are applied for on or

after the date of entry into force of this Regulation. Given that a certificate takes effect at

the end of the lawful term of the basic patent, which can be a relatively long time after the

date of filing of the application for the certificate, and in order to achieve the aim of this

Regulation, it is justified that this Regulation also cover, over a certain period of time, a

certificate that was applied for before the date of entry into force of this Regulation, but

has not yet taken effect before that date, irrespective of whether or not that certificate was

granted before that date. The exception should apply, therefore, from [1 July 2022] [] to a

certificate that takes effect from the date of entry into force of this Regulation. The concept

of ‘certain period of time’ for each individual certificate that takes effect after the date of

entry into force of this Regulation should ensure that the exception is applied, on a

progressive basis, to such a certificate, depending on the date on which it takes effect and

on its duration. Such application of the exception would allow the holder of a certificate

that has been granted, but that has not yet taken effect by the date of the entry into force of

this Regulation, a reasonable period of transition to adapt to the changed legal context,

while at the same time ensuring that makers of generics and biosimilars can benefit

effectively, without excessive delay, from the exception.

 OJ: date to be replaced by the date corresponding to three years from date of entry into force
of this amending Regulation.

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(27) Typically, an applicant for a certificate files an application at approximately the same date

in each Member State of filing. However, due to differences in national procedures for the

examination of applications, the date of grant of the certificate might vary significantly

from one Member State to another, thereby creating disparities in the legal situation of the

applicant in the Member States in which the certificate was applied for. Introducing the

exception on the basis of the date of the filing of the application for a certificate would

therefore promote uniformity and limit the risk of disparities.

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(28) The Commission should carry out a regular evaluation of this Regulation. Pursuant to the

Interinstitutional Agreement of 13 April 2016 on Better Law-Making **[1]**, that evaluation

should be based on the five criteria of effectiveness, efficiency, relevance, coherence and

added value and should provide the basis for impact assessments of possible further

measures. That evaluation should take into account, on the one hand, exports to outside the

Union, and on the other, the effects of storing on the swifter entry of generics and

especially biosimilars into markets in the Union as soon as possible after a certificate

expires. Such regular evaluation should also address the effects of this Regulation on the

making of generics and biosimilars in the Union by makers of generics and biosimilars

established in the Union. In that context, it would be important to ascertain whether

making that was previously taking place outside of the Union would be moved to within

Union territory. In particular, that evaluation should review the effectiveness of the

exception in the light of the aim to restore a global level playing field for makers of

generics and biosimilars in the Union. It should also study the impact of the exception on

research and production of innovative medicines in the Union by certificate holders and

consider the balance between the different interests at stake, in particular as regards public

health, public expenditure and, in this context, access to medicines within the Union. It

should also study whether the period provided for as regards the making of generics and

biosimilars for the purpose of storing is sufficient to achieve the objective of EU day-one

entry, including its effects on public health.

**1** OJ L 123, 12.5.2016, p. 1.

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(29) Since the objective of this Regulation, namely to promote the competitiveness of the

Union, in a manner that creates a level playing field for makers of generics and biosimilars

in relation to their competitors in third-country markets in which protection does not exist

or has expired, by laying down rules enabling the making of a product, or a medicinal

product containing that product, during the term of the corresponding certificate, and also

by providing for certain information, labelling and due diligence obligations for makers

that use those rules, cannot be sufficiently achieved by the Member States but can rather,

by reason of its scale and effects, be better achieved at Union level, the Union may adopt

measures, in accordance with the principle of subsidiarity as set out in Article 5 of the

Treaty on European Union. 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 that

objective.

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(30) This Regulation respects fundamental rights and observes the principles recognised by the

Charter of Fundamental Rights of the European Union (‘the Charter’). In particular, this

Regulation seeks to ensure full respect for the right to property and the right to health care

set out respectively in Articles 17 and 35 of the Charter. This Regulation should maintain

the core rights of the certificate, by limiting the exception provided for in this Regulation

to the making of a product, or a medicinal product containing that product, only for the

purpose of export outside the Union or for the purpose of storing for a limited period of

time with a view to entry into the Union market upon expiry of the protection, and to the

acts strictly necessary for such making or for the actual export or the actual storing. In the

light of those fundamental rights and principles, the exception provided for in this

Regulation does not go beyond what is necessary and appropriate in the light of the overall

objective of this Regulation, which is to promote the competitiveness of the Union by

avoiding relocation and allowing makers of generics and biosimilars established in the

Union to compete, on the one hand, on fast-growing global markets where protection does

not exist or has already expired, and on the other, on the Union market upon expiry of the

certificate. Indeed, it is necessary to benefit from the positive economic effects arising

from the exception, as otherwise the Union would risk substantially weakening its position

as a hub for pharmaceutical development and manufacturing. It is therefore appropriate to

introduce that exception in order to increase the competitive position of makers of generics

and biosimilars established in the Union in third countries whose markets are in any event

open to competition, whilst leaving the scope and duration of the protection granted by the

certificate in the Union untouched. The appropriateness of the measure is further ensured

by providing for appropriate safeguards regulating the use of the exception. This

Regulation should allow sufficient time for public authorities to put in place the necessary

arrangements to receive and publish notifications,

HAVE ADOPTED THIS REGULATION:

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_Article 1_

_Amendment of Regulation (EC) No 469/2009_

Regulation (EC) No 469/2009 is amended as follows:

(1) in Article 1, the following point is added:

‘(f) “maker” means the person, established in the Union, on whose behalf the making of

a product, or a medicinal product containing that product, for the purpose of export

to third countries or for the purpose of storing, is carried out;’;

(2) Article 5 is replaced by the following:

‘ _Article 5_

_Effects of the certificate_

1. Subject to the provisions of Article 4, the certificate shall confer the same rights as

conferred by the basic patent and shall be subject to the same limitations and the

same obligations.

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2. By way of derogation from paragraph 1, the certificate referred to in paragraph 1

shall not confer protection against certain acts which would otherwise require the

consent of the holder of the certificate (‘the certificate holder’), if the following

conditions are met:

(a) the acts comprise:

(i) the making of a product, or a medicinal product containing that product,

for the purpose of export to third countries; or

(ii) any related act that is strictly necessary for the making, in the Union,

referred to in point (i), or for the actual export; or

(iii) the making, no earlier than six months before the expiry of the certificate,

of a product, or a medicinal product containing that product, for the

purpose of storing it in the Member State of making, in order to place

that product, or a medicinal product containing that product, on the

market of Member States after the expiry of the corresponding

certificate; or

(iv) any related act that is strictly necessary for the making, in the Union,

referred to in point (iii), or for the actual storing, provided that such

related act is carried out no earlier than six months before the expiry of

the certificate.

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(b) the maker, through appropriate and documented means, notifies the authority

referred to in Article 9(1) in the Member State in which that making is to take

place, and informs the certificate holder, of the information listed in

paragraph 5 no later than three months before the start date of the making in

that Member State, or no later than three months before the first related act,

prior to that making, that would otherwise be prohibited by the protection

conferred by a certificate, whichever is the earlier;

(c) if the information listed in paragraph 5 changes, the maker notifies the

authority referred to in Article 9(1) and informs the certificate holder, before

those changes take effect;

(d) in the case of products, or medicinal products containing those products, made

for the purpose of export to third countries, the maker ensures that a logo, in

the form set out in Annex -I, is affixed to the outer packaging of the product, or

the medicinal product containing that product, referred to in point (a)(i) of this

paragraph, and, where feasible, to its immediate packaging;

(e) the maker complies with paragraph 9 of this Article and, if applicable, with

Article 12(2).

3. The exception referred to in paragraph 2 shall not apply to any act or activity carried

out for the import of products, or medicinal products containing those products, into

the Union merely for the purpose of repackaging, re-exporting or storing.

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4. The information provided to the certificate holder for the purposes of points (b) and

(c) of paragraph 2 shall be used exclusively for the purposes of verifying whether the

requirements of this Regulation have been met and, where applicable, initiating legal

proceedings for non-compliance.

5. The information to be provided by the maker for the purposes of point (b) of

paragraph 2 shall be as follows:

(a) the name and address of the maker;

(b) an indication of whether the making is for the purpose of export, for the

purpose of storing, or for the purpose of both export and storing;

(c) the Member State in which the making and, if applicable, also the storing is to

take place, and the Member State in which the first related act, if any, prior to

that making is to take place;

(d) the number of the certificate granted in the Member State of making, and the

number of the certificate granted in the Member State of the first related act, if

any, prior to that making; and

(e) for medicinal products to be exported to third countries, the reference number

of the marketing authorisation, or the equivalent of such authorisation, in each

third country of export, as soon as it is publicly available.

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6. For the purposes of notification to the authority under points (b) and (c) of

paragraph 2, the maker shall use the standard form for notification contained in

Annex -Ia.

7. Failure to comply with the requirements of point (e) of paragraph 5 with regard to a

third country shall only affect exports to that country, and those exports shall

therefore not benefit from the exception.

8. The maker shall ensure that medicinal products made pursuant to point (a)(i) of

paragraph 2 do not bear an active unique identifier within the meaning of

Commission Delegated Regulation (EU) 2016/161 **[*]** .

9. The maker shall ensure, through appropriate and documented means, that any person

in a contractual relationship with the maker who performs acts falling under point (a)

of paragraph 2 is fully informed and aware of the following:

(a) that those acts are subject to paragraph 2;

(b) that the placing on the market, import or re-import of the product, or the

medicinal product containing that product, referred to in point (a)(i) of

paragraph 2 or the placing on the market of the product, or the medicinal

product containing that product, referred to in point (a)(iii) of paragraph 2

could infringe the certificate referred to in paragraph 2 where, and for as long

as, that certificate applies.

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10. Paragraph 2 shall apply to certificates that are applied for on or after … [the date of

entry into force of this amending Regulation].

Paragraph 2 shall also apply to certificates that have been applied for before … [the

date of entry into force of this amending Regulation] and that take effect on or after

that date. Paragraph 2 shall only apply to such certificates from [1 July 2022] [] .

Paragraph 2 shall not apply to certificates that take effect before … [the date of entry

into force of this amending Regulation].

______________

***** Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing
Directive 2001/83/EC of the European Parliament and of the Council by laying down
detailed rules for the safety features appearing on the packaging of medicinal
products for human use (OJ L 32, 9.2.2016, p. 1).’;

 OJ: date to be replaced by the date corresponding to three years from date of entry into force
of this amending Regulation.

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(3) in Article 11, the following paragraph is added:

‘4. The authority referred to in Article 9(1) shall publish, as soon as possible, the

information listed in Article 5(5), together with the date of notification of that

information. It shall also publish, as soon as possible, any changes to the information

notified in accordance with point (c) of Article 5(2).’;

(4) Article 12 is replaced by the following:

‘ _Article 12_

_Fees_

1. Member States may require that the certificate be subject to the payment of annual

fees.

2. Member States may require that the notifications referred to in points (b) and (c) of

Article 5(2) be subject to the payment of a fee.’;

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(5) the following Article is inserted:

‘ _Article 21a_

_Evaluation_

No later than five years after the date referred to in Article 5(10), and every five years

thereafter, the Commission shall carry out an evaluation of Article 5(2) to (9) and

Article 11 in order to assess whether the objectives of those provisions have been achieved,

and present a report on the main findings to the European Parliament, the Council and the

European Economic and Social Committee. In addition to evaluating the impact of the

exception of making for the purpose of export, special account shall be taken of the effects

of making for the purpose of storing in order to place that product, or a medicinal product

containing that product, on the market of Member States after the expiry of the

corresponding certificate on access to medicines and on public health expenditure, and of

whether the waiver and in particular the period provided for in point (a)(iii) of Article 5(2)

is sufficient to achieve the objectives referred to in Article 5, including public health.’;

(6) Annex -I and -Ia as set out in the Annex to this Regulation are inserted.

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_Article 2_

_Entry into force_

This Regulation shall enter into force on the twentieth day following that of its publication in the

_Official Journal of the European Union_ .

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

Done at …,

_For the European Parliament_ _For the Council_

_The President_ _The President_

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The following Annexes are inserted:

**ANNEX**

‘ANNEX -I

Logo

This logo shall appear in black and in such a size as to be sufficiently visible.

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ANNEX -Ia

Standard form for notification pursuant to points (b) and (c) of Article 5(2)

|Tick the appropriate box| New notification<br> Update of an existing notification|Col3|
|---|---|---|
|(a) Name and address of the maker|…|…|
|(b) Purpose of making| Export<br> Storing<br> Export and storing| Export<br> Storing<br> Export and storing|
|(c) Member State in which making<br>is to take place and<br>Member State in which first<br>related act (if any) prior to<br>making is to take place|Member State of<br>making|…|
|(c) Member State in which making<br>is to take place and<br>Member State in which first<br>related act (if any) prior to<br>making is to take place|(Member State of<br>first related act (if<br>any))|…|
|(d) Number of certificate granted in<br>the Member State of making<br>and number of certificate<br>granted in Member State of first<br>related act (if any) prior to<br>making|Certificate of<br>Member State of<br>making|…|
|(d) Number of certificate granted in<br>the Member State of making<br>and number of certificate<br>granted in Member State of first<br>related act (if any) prior to<br>making|(Certificate of<br>Member State of<br>first related act (if<br>any))|…|
|(e) For medicinal products to be<br>exported to third countries,<br>reference number of marketing<br>authorisation, or the equivalent<br>of such authorisation, in each<br>third country of export|…|…|
|(e) For medicinal products to be<br>exported to third countries,<br>reference number of marketing<br>authorisation, or the equivalent<br>of such authorisation, in each<br>third country of export|…|…|
|(e) For medicinal products to be<br>exported to third countries,<br>reference number of marketing<br>authorisation, or the equivalent<br>of such authorisation, in each<br>third country of export|…|…|

’

.

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# ANNEX ECOMP.3.B EN