I 
(Legislativ e acts) 
REGUL ATIONS 
REGUL ATION (EU) 2019/933 OF THE EUR OPEAN PARLIAMENT AND OF THE COUNCIL 
of 20 May 2019 
amending Regulation (EC) No 469/2009 concer ning the supplementar y protection certificate for 
medicinal products 
(Text with EEA relevance) 
THE EUR OPEAN PARLIAMENT AND THE COUNCIL OF THE EUR OPEAN UNION, 
Having regar d to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, 
Having regar d to the proposal from the European Commission, 
After transmission of the draf t legislative act to the national parliaments, 
Having regar d to the opinion of the European Economic and Social Committ ee (1), 
Acting in accordance with the ordinar y legislative procedure (2), 
Whereas: 
(1)  Regulation (EC) No 469/2009 of the European Parliament and of the Council (3) provid es that any product 
prot ected by a patent in the territory of a Member State and subject, prior to being placed on the mark et as 
a medicinal product, to an administrative author isation 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 provid ed 
for in that Regulation, be the subject of a supplementar y prote ction certificate (‘cer tificate’). 
(2)  By providing for a period of supplementar y protect ion, Regulation (EC) No 469/2009 seeks to promote, within 
the Union, the research and innovati on that is necessar y to develop medicinal products, and to contr ibute to 
preventing the relocation of phar maceutical researc h outside the Union to countr ies that might offer great er 
prot ection. 
(3) Since the adop tion in 1992 of the predecessor to Regulation (EC) No 469/2009, mark ets have evolved signif i­
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 countr ies outside the Union (‘third countr ies’) in which prot ection does 
not exist or has expired. 11.6.2019 L 153/1 Official Jour nal of the European Union EN     
(1)OJ C 440, 6.12.2018, p. 100. 
(2)Position of the European Parliament of 17 Apr il 2019 (not yet published in the Offi cial Jour nal) 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 concer ning the supplementar y prot ection 
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 
veterinar y medicinal products (OJ L 311, 28.11.2001, p. 1). Directive 2001/82/EC is repealed and replaced, with effec t from 28 Januar y 
2022, by Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinar y 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). (4)  The absence in Regulation (EC) No 469/2009 of any excep tion to the prot ection conferr ed by the certificate has 
had the unintended consequence of preventing make rs of gener ics and biosimilars established in the Union from 
making generics and biosimilars in the Union, even for the purpose of expor t to third-countr y mark ets in which 
prot ection does not exist or has expired. Likewise, makers are prevent ed from making generics and biosimilars 
for the purpose of stori ng them for a limited period before the expir y of the certificate. Those circumstances 
make it more difficult for those makers, in contrast to make rs locat ed in third countr ies where prot ection does 
not exist or has expired, to enter the Union mark et immediately after expir y of the certificate, given that they are 
not in a position to build up production capacity for the purpose of expor t or for the purpose of entering the 
mark et of a Member State until the protection provi ded by that certificate has expired. 
(5)  Those circumstances put make rs of gener ics and biosimilars established in the Union at a signif icant competitive 
disadvantag e in comparison with make rs based in third countr ies that offer less or no prote ction. The Union 
should strike a balance between restor ing a level playing field between those makers and ensur ing that the 
essence of the excl usive rights of holders of certificates (‘cer tificate holders’) is guarant eed in relation to the Union 
mark et. 
(6)  Without inter vention, the viability of makers of gener ics and biosimilars established in the Union could be 
threate ned, with consequences for the Union's phar maceutical industr ial base as a whole. That situation could 
affect the fully effective functioning of the internal mark et through the loss of pote ntial new business oppor tun­
ities for mak ers of gener ics and biosimilars, thereby possibly diminishing related investments and hamp ering job 
creation within the Union. 
(7)  The timely entr y of gener ics and biosimilars into the Union mark et is important, particularly in order to increase 
competiti on, to reduce prices and to ensure that national healthcare syste ms are sustainable and that patients in 
the Union have better access to affordable medicines. The importance of such timely entr y was underlined by the 
Council in its conclusions of 17 June 2016 on strengthening the balance in the phar maceutical systems in the 
Union and its Member State s. Regulation (EC) No 469/2009 should, theref ore, be amended so as to allow the 
making of gener ics and biosimilars for expor t and stori ng, while bear ing in mind that intellectual proper ty rights 
remain one of the cornerst ones of innovati on, competitiveness and growth in the internal mark et. 
(8)  The aim of this Regulation is to promote the compet itiveness of the Union, thereby enhancing growth and job 
creation in the internal market and contr ibuting to a wider supply of products under unif orm conditions, by 
allowing mak ers of generics and biosimilars established in the Union to make in the Union products, or 
medicinal products containing those products, for the purpose of expor t to third-countr y mark ets in which 
prot ection does not exist or has expired, thereb y also helping those make rs to compet e effectively in those third- 
countr y mark ets. This Regulation should also allow such make rs to make and store products, or medicinal 
products containing those products, in a Member State for a defined period pending the expir y of the certificate, 
for the purpose of entering the market of any Member State upon expir y of the corresponding certificate, thereby 
helping those mak ers to compet e effectively in the Union immediately after prot ection has expired (‘EU day-one 
entr y’). This Regulation should also compl ement the efforts of the Union's trade policy to ensure open mark ets 
for makers of products, or medicinal products containing those products, established in the Union. Over time, 
this Regulation should benefit the entire phar maceutical sector in the Union, by allowing all players, including 
new comers, to reap the benefi ts of the new oppor tunities opening up in the fast-changing global phar maceutical 
mark et. Further more, the general interest of the Union would be promote d given that, by reinf orcing Union- 
based supply chains for medicines and by allowing stor ing with a view to entr y into the Union mark et upon 
expir y of the certificate, medicines would become more accessible to patients in the Union after the expir y of the 
certificate. 
(9)  In those specific and limite d circumstances, and in order to create a level playing field between mak ers 
established in the Union and third-countr y mak ers, it is appropr iate to provid e for an excep tion to the prot ection 
conferred by a certificate so as to allow the making of a product, or a medicinal product containing that product, 
for the purpose of expor t to third countr ies or of stor ing, and any relat ed acts in the Union strictly necessar y for 
that making or for the actual expor t or the actual storing, where such acts would other wise require the consent 
of a certificate holder (‘related acts ’). For instance, such relat ed acts could include: possessing; offering to supply ; 
supplying; importing; using or synthesising an active ingredient for the purpose of making a medicinal product ; 
or temporar y storing or adver tising for the excl usive purpose of expor t to third-countr y destinations. That 
excep tion should also apply to relat ed acts perf ormed by third parties who are in a contractual relationship with 
the make r. 11.6.2019 L 153/2 Official Jour nal of the European Union EN     (10)  The excep tion should apply to a product, or a medicinal product containing that product, prot ected by 
a certificate. It should cover the making of the product protect ed by a certificate in the territory of a Member 
State and the making of the medicinal product containing that product. 
(11)  The excep tion should not cover placing a product, or a medicinal product containing that product, whic h is 
made for the purpose of expor t to third countr ies or of storing with a view to EU day-one entr y, on the mark et 
of a Member State where a certificate is in force, either directly or indirectly after expor t, nor should it cover re- 
importation of such a product, or medicinal product containing that product, into the mark et 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 
repac kaging and re-expor ting. In addition, the excep tion 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 excep tion to making for the purpose of expor t outside the Union or to making for 
the purpose of stor ing, and to acts strictly necessar y for such making or for the actual expor t or the actual 
storing, the excep tion provided for in this Regulation should not conf lict with the normal exploitation of the 
product, or the medicinal product containing that product, in the Member State in whic h 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 excep tion should not 
unreasonably prejudice the legitimate interests of the certificate holder , whilst taking account of the legitimate 
inter ests of third parties. 
(13)  Effective and propor tionate safeg uards should apply in relation to the excep tion in order to increase transparency , 
to help the holder of a certificate enforce its prot ection in the Union and check compl iance 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 oblig ation 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 expor t or stori ng, is carried out. It is possible that the make r directly carries out the making. That 
information oblig ation should consist of requir ing the make r to provid e certain information to the compet ent 
industr ial proper ty office, or another designate d author ity, which grant ed the certificate (‘the author ity’) in the 
Member State where the making is to take place. A standard form for notifi cation should be provid ed 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 relat ed act prior to that making, 
whic hever is the earlier . The information should be updated as and when appropr iate. The making of a product, 
or a medicinal product containing that product, and the relat ed acts, including those performe d in Member States 
other than the one of making in cases where the product is also protect ed by a certificate in those other Member 
States, should only fall within the scope of the exce ption where the maker has sent the notifi cation to the 
author ity 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 notifi cation should be 
required in each of those Member State s. In the interests of transparency , the author ity 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 notific ations, and updat es 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 notificati ons and updat es. 
(15)  The mak er should also inform the certificate holder , through appropr iate and document ed means, of the 
intenti on to make a product, or a medicinal product containing that product, pursuant to the excep tion, by 
provid ing the certificate holder with the same information as notified to the author ity. That information should 
be limite d to what is necessar y and appropr iate for the certificate holder to assess whether the rights conferred 
by the certificate are being respected , and should not include conf idential or commercially sensitive information. 
The standard form for notificati on could also be used to inform the certificate holder , and the information 
provid ed should be update d as and when appropr iate. 11.6.2019 L 153/3 Official Jour nal of the European Union EN     (16)  With regard to relat ed acts, if any, prior to the making of a product, or a medicinal product containing that 
product, the notifi cation should indicate the name of the Member State in which the first relat ed act which would 
other wise 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 author isation, or the equivalent of such author isation, in a specific third countr y, for a given 
medicinal product, is published after the author ity is notified , the notificati on should be prom ptly updat ed to 
include the reference number of that marketing author isation, or the equivalent of such author isation, as soon as 
it is publicly available. If the referen ce number of that mark eting author isation, or the equivalent of such author ­
isation, is pending publication, the maker should be required to provide, in the notifi cation, that reference 
number as soon as it is publicly available. 
(18)  For reasons of propor tionality , failure to compl y with the requirement regar ding a third countr y should only 
affect expor ts to that countr y, and expor ts to that countr y should, thus, not benefit from the excep tion provided 
for in this Regulation. It should be the responsibility of the mak er established in the Union to verify that 
prot ection does not exist or has expired in a countr y of expor t, or whether that protection is subject to any 
limitations or exem ptions in that countr y. 
(19)  A notifi cation to the author ity and the corresponding information to the certificate holder could be provid ed 
during the period between the date of entr y into force of this Regulation and the date on which the excep tion 
provid ed 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 
excep tion. The make r should be required to inform persons within its supply chain in the Union, including the 
expor ter and the person carrying out the storing, through appropr iate and documented means, in particular 
contractual means, that the product, or the medicinal product containing that product, is covered by the 
excep tion provided for in this Regulation and that the making is intende d for the purpose of expor t or storing. 
A maker who fails to compl y with those due dilig ence requirements should not benefi t from the excep tion, nor 
should any third party performi ng a relat ed act in the Member State of making or in a diffe rent Member State in 
whic h a certificate conferr ing protect ion for the product is in force. The holder of the relevant certificate would, 
theref ore, be entitled to enforce its rights under the certificate, while having due regar d to the general obligation, 
provid ed for in Directive 2004/48/EC of the European Parliament and of the Council (6), not to engag e 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 expor ted, in order to facilitate, by means of a logo, identif ication of such 
products or such medicinal products as being excl usively intended for the purpose of expor t to third 
countr ies. Making for the purpose of expor t and related acts should only fall within the scope of the excep tion if 
the product, or the medicinal product containing that product, is labelled in the manner provided for in this 
Regulation. That labelling oblig ation should be without prejudice to labelling requirements of third countr ies. 
(22)  Any act not covered by the excep tion provided for in this Regulation should remain within the scope of the 
prot ection conferr ed by a certificate. Any diversion onto the Union mark et, during the term of the certificate, of 
any product, or any medicinal product containing that product, made under the exce ption, should remain 
prohibit ed. 
(23)  This Regulation is without prejudice to other intellectual proper ty 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 facilita te enforcement, of intellectual proper ty rights, including 
Directive 2004/48/EC and Regulation (EU) No 608/2013 of the European Parliament and of the Council (7). 11.6.2019 L 153/4 Official Jour nal of the European Union EN     
(6)Directive 2004/48/EC of the European Parliament and of the Council of 29 Apr il 2004 on the enforcement of intellectu al proper ty 
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 concer ning customs enforcement of 
intel lectual proper ty rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15). (24)  This Regulation does not affect the rules on the unique identif ier, provid ed for in Directive 2001/83/EC. The 
make r should ensure that any medicinal product made for the purpose of expor t, pursuant to this Regulation, 
does not bear an active unique identif ier within the meaning of Commission Deleg ated Regulation (EU) 
2016/161 (8). Howe ver, under that Delegat ed 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 expir y 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 manuf actur ing author isation of medicinal products made for expor t. This includes 
compl iance with the principles and guidelines of good manuf actur ing practices for medicinal products and using 
only active substances which have been manufactured in accordance with good manuf actur ing practices for 
active substances and distr ibut ed in accordance with good distr ibution practices for active substances. 
(26)  To safeg uard the rights of certificate holders, the excep tion provided for in this Regulation should not apply to 
a certificate that has already take n effect at the date of entr y into force of this Regulation. In order to ensure that 
the rights of certificate holders are not excessively restr icted, the excep tion should apply to certificates that are 
applied for on or after the date of entr y into force of this Regulation. Given that a certificate takes effect at the 
end of the lawful term of the basic pate nt, which can be a relatively long time after the date of filing of the 
application for the certificate, and in order to achi eve 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 entr y 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 excep tion should apply , theref ore, from 2 July 2022 to a certificate 
that takes effect from the date of entr y into force of this Regulation. The concept of ‘certain period of time ’ for 
each individual certificate that takes effect after the date of entr y into force of this Regulation should ensure that 
the excep tion 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 excep tion would allow the holder of a certificate that has been 
grant ed, but that has not yet taken effect by the date of the entr y into force of this Regulation, a reasonable 
period of transition to adap t to the changed legal cont ext, while at the same time ensur ing that makers of 
gener ics and biosimilars can benefit effectively , without excessiv e dela y, from the excep tion. 
(27)  Typically , an applicant for a certificate files an application at appro ximat ely the same date in each Member State 
of filing. Howe ver, due to diffe rences in national procedures for the examination of applications, the date of grant 
of the certificate might vary signif icantly from one Member State to another , thereby creating dispar ities in the 
legal situation of the applicant in the Member States in which the certificate was applied for. Introducing the 
excep tion on the basis of the date of the filing of the application for a certificate would, theref ore, promot e 
unif ormity and limit the risk of dispar ities. 
(28)  The Commission should carry out a regular evaluation of this Regulation. Pursuant to the Interin stitutional 
Agreement of 13 Apr il 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, expor ts to 
outside the Union, and on the other , the effects of stor ing on the swif ter entr y of gener ics and especially 
biosimilars into mark ets 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 gener ics and biosimilars in the Union by 
make rs of generics and biosimilars established in the Union. In that conte xt, it would be important to ascer tain 
whether making that was previously taking place outside of the Union would be move d to within Union 
territory. In particular , that evaluation should review the effectiveness of the excep tion in the light of the aim to 
restore a global level playing field for mak ers of gener ics and biosimilars in the Union. It should also study the 
impact of the excep tion on researc h and production of innovati ve medicines in the Union by certificate holders 
and consider the balance between the diffe rent interests at stake , in particular as regar ds public health, public 
expenditure and, in this context, access to medicines within the Union. It should also study whether the period 
provid ed for as regar ds the making of gener ics and biosimilars for the purpose of stor ing is suffi cient to achi eve 
the objective of EU day-one entr y, including its effects on public health. 11.6.2019 L 153/5 Official Jour nal of the European Union EN     
(8)Commission Delegat ed 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 safet y features appear ing on the pack aging of medicinal products for human use 
(OJ L 32, 9.2.2016, p. 1). 
(9)OJ L 123, 12.5.2016, p. 1. (29)  Since the objective of this Regulation, namely to promot e the competiti veness of the Union, in a manner that 
creat es a level playing field for makers of gener ics and biosimilars in relation to their compe titors in third- 
countr y markets in which prote ction 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 provid ing for certain information, labelling and due diligence oblig ations 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 bette r 
achi eved at Union level, the Union may adop t measures, in accordance with the principle of subsidiar ity as set 
out in Article 5 of the Treaty on European Union. In accordance with the principle of propor tionality as set out 
in that Article, this Regulation does not go beyond what is necessar y in order to achi eve that objective. 
(30)  This Regulation respects fundamental rights and obser ves the principles recognised by the Char ter of 
Fundamental Rights of the European Union (‘the Char ter’). In particular , this Regulation seeks to ensure full 
respect for the right to proper ty and the right to health care set out respectively in Articles 17 and 35 of the 
Char ter. This Regulation should maintain the core rights of the certificate, by limiting the excep tion provid ed for 
in this Regulation to the making of a product, or a medicinal product containing that product, only for the 
purpose of expor t outside the Union or for the purpose of storing for a limite d period of time with a view to 
entr y into the Union mark et upon expir y of the prote ction, and to the acts strictly necessar y for such making or 
for the actual expor t or the actual stori ng. In the light of those fundamental rights and principles, the excep tion 
provid ed for in this Regulation does not go beyond what is necessar y and appropr iate in the light of the overall 
objective of this Regulation, whic h is to promot e the competitiveness of the Union by avoiding relocation and 
allowing makers of gener ics and biosimilars established in the Union to compet e, on the one hand, on fast- 
growing global mark ets where protection does not exist or has already expired, and on the other , on the Union 
mark et upon expir y of the certificate. Indeed, it is necessar y to benefit from the positive economic effects arising 
from the excep tion, as other wise the Union would risk substantially weakening its position as a hub for phar ma­
ceutical development and manufact uring. It is, theref ore, appropr iate to introduce that exce ption in order to 
increase the compet itive position of makers of gener ics and biosimilars established in the Union in third 
countr ies whose markets are in any event open to competiti on, whilst leavin g the scope and duration of the 
prot ection grant ed by the certificate in the Union untouc hed. The appropr iateness of the measure is further 
ensured by providing for appropr iate safeg uards regulating the use of the exce ption. This Regulation should allow 
sufficient time for public author ities to put in place the necessar y arrangements to receive and publish notifi ­
cations, 
HAVE ADOPTED THIS REGUL ATION: 
Article 1 
Amendment of Regulation (EC) No 469/2009 
Regulation (EC) No 469/2009 is amended as follows:  
(1) in Article 1, the followi ng 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 expor t to third countr ies or for the purpose of storing, is 
carried out;’;  
(2) Article 5 is replaced by the follo wing: 
‘Article 5 
Effects of the certificate 
1. Subject to the provisions of Article 4, the certificate shall confer the same rights as conferr ed by the basic 
patent and shall be subject to the same limitations and the same obligations. 
2. By way of derog ation from paragraph 1, the certificate refer red to in paragraph 1 shall not confer protection 
against certain acts whic h would other wise require the consent of the holder of the certificate (“the certificate 
holder”), if the following conditions are met : 
(a)  the acts compris e: 
(i)  the making of a product, or a medicinal product containing that product, for the purpose of expor t to third 
countr ies; or 11.6.2019 L 153/6 Official Jour nal of the European Union EN     (ii)  any relat ed act that is strictly necessar y for the making, in the Union, referred to in point (i), or for the 
actual expor t; or 
(iii)  the making, no earlier than six months before the expir y of the certificate, of a product, or a medicinal 
product containing that product, for the purpose of stori ng it in the Member State of making, in order to 
place that product, or a medicinal product containing that product, on the mark et of Member States after 
the expir y of the corresponding certificate; or 
(iv)  any relat ed act that is strictly necessar y 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 expir y of 
the certificate. 
(b)  the mak er, through appropr iate and documente d means, notifi es the author ity referred to in Article 9(1) in the 
Member State in whic h 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 relat ed act, prior to that making, that would other wise be 
prohibit ed by the protection confe rred by a certificate, which ever is the earlier; 
(c)  if the information listed in paragraph 5 of this Article changes, the make r notifi es the author ity 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 expor t to 
third countr ies, the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packag ing 
of the product, or the medicinal product containing that product, refer red to in point (a)(i) of this paragraph, 
and, where feasible, to its immediate packag ing; 
(e)  the mak er compl ies with paragraph 9 of this Article and, if applicable, with Article 12(2). 
3. The excep tion refer red 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 repack aging, 
re-expor ting or stori ng. 
4. The information provid ed to the certificate holder for the purposes of points (b) and (c) of paragraph 2 shall 
be used excl usively for the purposes of verifying whether the requirements of this Regulation have been met and, 
where applicable, initiating legal proceedings for non-com pliance. 
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 make r; 
(b)  an indication of whether the making is for the purpose of expor t, for the purpose of stori ng, or for the purpose 
of both expor t and stori ng; 
(c)  the Member State in which the making and, if applicable, also the stori ng is to take place, and the Member State 
in whic h the first related act, if any, prior to that making is to take place; 
(d)  the number of the certificate grant ed 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 expor ted to third countr ies, the reference number of the mark eting author isation, 
or the equivalent of such author isation, in each third countr y of expor t, as soon as it is publicly available. 
6. For the purposes of notifi cation to the author ity under points (b) and (c) of paragraph 2, the maker shall use 
the standard form for notifi cation contained in Annex -Ia. 
7. Failure to comply with the requirements of point (e) of paragraph 5 with regard to a third countr y shall only 
affect expor ts to that countr y, and those expor ts shall, theref ore, not benefi t from the excep tion. 
8. The mak er 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 Delegat ed Regulation (EU) 2016/161 (*). 11.6.2019 L 153/7 Official Jour nal of the European Union EN     9. The maker shall ensure, through appropr iate and documented means, that any person in a contractual 
relationship with the make r who performs acts falling under point (a) of paragraph 2 is fully informed and awar e of 
the following: 
(a)  that those acts are subject to paragraph 2; 
(b)  that the placing on the market, import or re-impor t of the product, or the medicinal product containing that 
product, refer red to in point (a)(i) of paragraph 2 or the placing on the mark et of the product, or the medicinal 
product containing that product, refer red 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 Deleg ated 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 appear ing on 
the packag ing 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 author ity referred to in Article 9(1) shall publish, as soon as possible, the information listed in 
Article 5(5), together with the date of notificati on of that information. It shall also publish, as soon as possible, any 
chang es to the information notifi ed in accordance with point (c) of Article 5(2).’;  
(4) Article 12 is replaced by the followi ng: 
‘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 notifi cations refer red to in points (b) and (c) of Article 5(2) be subject to 
the payment of a fee.’;  
(5) the following Article is inser ted: 
‘Article 21a 
Evaluation 
No later than five years after the date referred to in Article 5(10), and ever y five years thereaf ter, 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 achi eved, and present a repor t 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 excep tion of making 
for the purpose of expor t, 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 mark et of Member States after the 
expir y of the corresponding certificate on access to medicines and on public health expenditure, and of whether the 
waiver and in particular the period provid ed for in point (a)(iii) of Article 5(2) is suffi cient to achieve the objectives 
refer red to in Article 5, including public health.’;  
(6) Annexes -I and -Ia as set out in the Annex to this Regulation are inser ted. 
Article 2 
Entr y into force 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 11.6.2019 L 153/8 Official Jour nal of the European Union EN     This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 20 May 2019. 
For the European Parliament 
The President 
A. TAJANI  For the Council 
The President 
G. CIAMBA   11.6.2019 L 153/9 Official Jour nal of the European Union EN     ANNEX 
The followi ng Annex es are inser ted: 
‘ANNEX -I 
Logo 
This logo shall appear in blac k 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 appropr iate box  
 New notific ation  
Update of an existing notifi cation 
(a)  Name and address of the make r … 
(b)  Purpose of making  
 Expor t  
Stor ing  
Expor t and storing 
(c)  Member State in which making is to take place and 
Member State in whic h first related act (if any) prior 
to making is to take place Member State of making … 
(Member State of first related act (if any)) … 
(d)  Number of certificate grant ed in the Member State 
of making and number of certificate grant ed in 
Member State of first relat ed act (if any) prior to 
making Certificate of Member State of making … 
(Cer tificate of Member State of first related act 
(if any)) … 
(e)  For medicinal products to be expor ted to third 
countr ies, reference number of mark eting author is­
ation, or the equivalent of such author isation, in 
each third countr y of expor t … 
… 
…’   11.6.2019 L 153/10 Official Jour nal of the European Union EN