11.6.

2019 EN Official Journal of the European Union L 153/1

(Legislative acts)

REGULATIONS

REGULATION (EU) 2019/933 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 20 May 2019
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),

Whereas:

(1) Regulation (EC) No 469/2009 of the European Parliament and of the Council (3) 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 (4) or
2001/83/EC (5) 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.

(3) Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have evolved signifi­
cantly 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.

(1) OJ C 440, 6.12.2018, p. 100.

(2) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and decision of the Council of 14 May
2019.
(3) 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).
(4) 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).
(5) 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).
L 153/2 EN Official Journal of the European Union 11.6.2019

(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.

(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 opportun­
ities 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.

(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.

(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.
11.6.2019 EN Official Journal of the European Union L 153/3

(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.

(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.

(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.

(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.
L 153/4 EN Official Journal of the European Union 11.6.2019

(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.

(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 author­
isation, 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.

(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 (6), not to engage in abusive
litigation.

(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 (7).

(6) 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).
(7) 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).
11.6.2019 EN Official Journal of the European Union L 153/5

(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 (8). 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.

(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 2 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.

(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.

(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 (9), 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.

(8) 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).
(9) OJ L 123, 12.5.2016, p. 1.
L 153/6 EN Official Journal of the European Union 11.6.2019

(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.

(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 pharma­
ceutical 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 notifi­
cations,

HAVE ADOPTED THIS REGULATION:

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.

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
11.6.2019 EN Official Journal of the European Union L 153/7

(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.

(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 of this Article 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 of this Article 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.

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.

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 (*).
L 153/8 EN Official Journal of the European Union 11.6.2019

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.

10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.

Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or
after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022.

Paragraph 2 shall not apply to certificates that take effect before 1 July 2019.
(*) 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).’;

(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.’;

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

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.
11.6.2019 EN Official Journal of the European Union L 153/9

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

Done at Brussels, 20 May 2019.

For the European Parliament For the Council

The President The President
A. TAJANI G. CIAMBA
L 153/10 EN Official Journal of the European Union 11.6.2019

ANNEX

The following Annexes are inserted:

‘ANNEX -I

Logo

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

ANNEX -Ia

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

Tick the appropriate box New notification

Update of an existing notification

(a) Name and address of the maker …

(b) Purpose of making Export

Storing
Export and storing

(c) Member State in which making is to take place and Member State of making …
Member State in which first related act (if any) prior
to making is to take place (Member State of first related act (if any)) …

(d) Number of certificate granted in the Member State Certificate of Member State of making …
of making and number of certificate granted in
Member State of first related act (if any) prior to (Certificate of Member State of first related act …
making (if any))

(e) For medicinal products to be exported to third …

countries, reference number of marketing authoris­
ation, or the equivalent of such authorisation, in …
each third country of export
…’