EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
delegated act safety features […](2015) XXX  
  
COMMISSION DELEGATED REGULATION (EU) No …/.. 
of XXX  
supplementing Directiv e 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 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
EU pharmaceutical legislation provides for a high level of public health protection through 
stringent rules guaranteeing the quality, safety an d efficacy of the medicines circulating in the 
EU market. On 8 June 2011, the European Pa rliament and the Council adopted Directive 
2011/62/EU1, amending Directive 2001/83/EC2 on the Community code relating to medicinal 
products for human use, which strengthens public  health protection by providing measures to 
fight the falsification of medicines even where there is no infringement of intellectual property rights. 
Falsified medicines are medicines with false identity (e.g. name, composition), history (e.g. 
batch number) or source which are passed off as genuine, authorised  products. Falsified 
medicines may contain ingredients, including activ e ingredients, which are of low quality or 
in the wrong dosage — either too high or too lo w. They can be a major health threat. Among 
the more severe incidents in the last few y ears, contaminated heparin — a blood thinner — 
has been connected to dozens of deaths worl dwide in 2008, including in the US and in the 
EU. 
Even though most incidents of falsification impli cate originator medicines, falsifications of 
generic medicines have also been reported. Falsif ied medicines have been detected both in the 
legal (e.g. authorised pharmacies and whol esalers) and illegal (e.g. supplies from/to 
unauthorised internet sites) supply chain. Fals ification affects both prescription and over-the-
counter medicines. Products against sexual dysfunction, heartburn and cancer are among the 
medicines most targeted by traffickers. 
Today, the medicine distribution chain is very complex and provides opportunities to 
traffickers to penetrate the legal supply chain and offer fake medicines to legal operators, 
despite the existing regulatory framework and it s controls. The problem is that there are no 
obligatory technology solutions in place that e ffectively prevent falsified medicines from 
entering the legal supply chain.  
To tackle this problem, Direct ive 2011/62/EU introduces obligatory ‘safety features' (a unique 
identifier and an anti-tampering device) as part of the outer pack aging of prescription 
medicinal products, although certain  derogations apply. In part icular, Directive 2011/62/EU 
places the Commission
3 under the obligation to adopt  delegated acts setting out: 
(a) the characteristics and technical specificati ons of the unique identifier; the modalities 
for the verification of the safety features ; the establishment and management of the 
repository system containing the unique identifiers; 
(b) the lists containing the medicinal products or product categories which, in the case of 
prescription medicines shall not bear the safety featur es, and in the case of non-
prescription medicines shall bear the safe ty features, established according to the 
criteria defined in Article 54a(2)(b)  of Directive 2001/83/EU, as amended; 
(c) the procedures for the notification of me dicinal products by the national competent 
authorities to the Commission, as regards non-prescription medicinal products they 
                                                 
1 Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC 
as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L 
174, 1.7.2011, p.74. 
2 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. 
3 Art. 54a(2) of Directive 2001/83/EC  
EN 3   EN judge to be at risk of falsification or medi cinal products they deem not to be at risk, 
and a rapid system for evaluating and deciding on such notification. 
Before adopting these delegated act, Artic le 4 of Directive 2011/62/EC requires the 
Commission to perform a st udy assessing benefits, costs and cost-effectiveness of: 
(a) the technical options for the unique identifier  (i.e.: what will be the composition of 
the unique identifier and the form at of the barcode holding it?); 
(b) the options for the extent of verification of  the authenticity of the medicinal product 
bearing the safety features and the practical  arrangements for such verification (i.e.: 
who will check the safety features and when?); 
(c) the technical options for establishing and managing the repository system (i.e.: who 
will establish and manage the reposito ry system? Who will supervise it?) 
To this end, the Commission conducted an imp act assessment and published the results in an 
impact assessment report accompanying the present Delegated Regulation. 
The options identified by the impact assessment as the most cost-effective constitute the core 
elements of this Delegated Regulation and are outlined below: 
(a) The composition, format and carrier of  the unique identifie r should be fully 
harmonised across the EU. The unique identif ier should be placed in a 2D barcode 
and contain the product code , a serial number, the national reimbursement number (if 
requested by Member States), the batch number and the expiry date. 
(b) Medicine authenticity should be guaranteed  by an end-to-end verification system 
supplemented by risk-based verifications  by wholesalers. Me dicines should be 
systematically verified before being supp lied to the public (e.g. at pharmacy level). 
Medicines at higher risk of  falsification (returned medi cines or medicines not being 
distributed directly by manu facturers, marketing authorisation holders or people 
acting on their behalf) shoul d additionally be checked at wholesaler level.  
(c) The repositories system containing the unique identifiers should be set up and 
managed by stakeholders. National competent authorities should how ever be able to 
access and supervise the repositories system. 
In addition, due consideration was given to the particular characte ristics of the supply chain in 
the Member States and to ensuring that the pr oposed rules are proportionate with regard the 
impact of the verification measur es on actors in the supply chain.  
Finally, in accordance with Article 54a(3) of  Directive 2001/83/EC, measures were taken to 
guarantee the protection of personal data as provided for in Union law, the legitimate interests 
to protect information of a commercially confidential nature and the ownership and 
confidentiality of the data generated by the use of  the safety features. It  should be noted that 
the present Delegated Regulation does not require  any personal data to be stored in the 
repositories system. The measures are rather  preventative and ensure the protection of 
personal data in case users of the repositories (e.g.: pharmacists) should decide to use the 
repositories system for purposes which are outside  the scope of this De legated Regulation and 
involve the use/storage/handling of patient data in the reposit ories (e.g.: e-pr escriptions). 
It should be noted that the present Delega ted Regulation does not set out the technical 
characteristics of the anti-tampering device since the Commission mandate, as delegated by 
the legislators, only covers the technical characteristics of the unique identifier. 
The lists containing the medicinal products or product categories which, in the case of 
prescription medicines shall not  bear the safety features, an d in the case of  non-prescription  
EN 4   EN medicines shall bear the safety features, we re populated in consultation with the Member 
States and taking into account th e risk of and the risk arisi ng from falsification of the 
medicinal products in accordance with Arti cle 54a(2)(b) of Directive 2001/83/EC, as 
amended. 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT 
With a view to preparing this Delegate d Regulation, the Commi ssion has carried out 
extensive consultations with  both internal and extern al interested parties. 
An internal Inter-Service Steering Group was set up and me t on 10 October 2011, 4 March 
2013 and 10 June 2013. To gain additional expertis e, there were close contacts with the 
European Medicines Agency on this file. 
The Commission has consulted experts from the national competent aut horities of all the 
Member States. An expert group on the delega ted act on safety features for medicinal 
products for human use was set up and met ni ne times between December 2011 and March 
2015. Member States largely agreed to harm onise the technical specifications and to 
coordinate the verification mechanism for the imp lementation of the safety features. Member 
States asked that the unique identifier should  contain as much information as possible in 
particular batch number, expiry date and reimbursement number and should be readable by electronic means. Member States also stressed the need for a system that can be reliably 
operated across the EU, taking into  account the specifici ties of the supply chain of individual 
Member States. Member States finally aske d the Commission to take into appropriate 
consideration the fact that, in  the EU, there are other partie s that can supply medicines to 
patients besides pharmacies. 
In June 2011, the Commission held a first m eeting with key European associations 
representing manufacturers, whol esale distributors, hos pitals and pharmacies to collect their 
first views on possible options fo r the characteristics and tech nical specifications of the 
unique identifier. 
On the basis of this preliminary discussion, the Commission submitted for public consultation 
a concept paper on the delegated act on the deta iled rules for safety features for medicinal 
products for human use. The consultation t ook place from 18 November 2011 to 27 April 
2012. The concept paper put forward various id eas and options for implementing the unique 
identifier. This public consultation was also us ed as a means of gathering further quantified 
information on the costs and effectiveness of th e various policy options. In total, 90 replies 
were received (mainly from industry, wholesal e distributors and pharmacies, but also from 
some Member States). The responses have b een published by the Commission on the Europa 
website
4. 
In a nutshell, all respondents expressed their full support for the Commission’s initiative, on 
the grounds that the unique iden tifier would create be tter protection for European patients 
against falsified medicines. Most res pondents supported harm onising the technical 
specifications of the unique id entifier across the Union to ensure interoperability among 
different manufacturers and diffe rent EU Member States. Most  stakeholders also supported 
the checking of the unique identifier at the end of the supply chain, name ly at the pharmacy or 
hospital level. Most industry supported a repository system set up and managed by the 
stakeholders. On the contrary , two national medicines Agenci es out of seven who replied 
favoured the EU or national governance of the re pository system while one authority called 
                                                 
4 http://ec.europa.eu/health/hum an-use/falsified_medicines/d evelopments/2012-06_pc_safety-
features.htm    
EN 5   EN for national governance only. Their views were also expressed during the meetings of the 
expert group. The European Consumer Organi sation stressed the importance to protect 
personal data in the repository system. 
The Commission further consulted with ke y European stakeholders in December 2012, 
December 2013 and April 2014. 
In November 2012, with the help of an ex ternal contractor, ECORYS, the Commission 
conducted an ex-ante evaluation of competitiveness proofing of the unique identifier for medicinal products for human use and its veri fication. The contractor  investigated the 
consequences of the different policy options on the competitivene ss of the pharmaceutical 
industry and identified corrective or mitigati ng measures. The relevant dimensions of 
competitiveness analysed in the study were: co st competitiveness, capacity to innovate and 
international competitiveness. 
The information gathered during the public consu ltation, the input of the Member State expert 
group and the ex-ante evaluation of competitiv eness proofing performed by ECORYS were 
taken into account when performing the asse ssment of the benefits, costs and cost-
effectiveness (‘impact assessment’) of the possible policy options for the unique identifier and its verification, as requested  by Directive 2001/62/EU.  
The impact assessment study was submitted to the Commission impact assessment board for 
scrutiny. The impact assessment board approved the study on 20 December 2013. The results of the study are summarised in the impact  assessment report accompanying the present 
Delegated Regulation. 
Comments stemming from all rounds of consulta tions as well as the outcome of the impact 
assessment study were taken into account wh en preparing this Delegated Regulation. 
3. LEGAL
 ELEMENTS  OF THE  DELEGATED  ACT 
The legal basis for this Delega ted Regulation is Article 54a, second paragraph, of Directive 
2001/83/EC on the Community code relating to  medicinal products for human use.  
This Delegated Regulation supplements Directive 2001/83/EC.   
EN 6   EN COMMISSION DELEGATED REGU LATION (EU) No …/.. 
of XXX  
supplementing Directive 2001/83/EC of the Euro pean Parliament and of the Council by 
laying down detailed rules for the safety features appearing on the packaging of 
medicinal products for human use 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 
6 November 2001 on the Community code relati ng to medicinal products for human use
5, and 
in particular Article 54a(2) thereof, 
Whereas:  
(1) Directive 2001/83/EC, as amended, provides for measures to prevent the entry into the 
legal supply chain of falsif ied medicinal products by requiring the placing of safety 
features consisting of a uni que identifier and an an ti-tampering device on the 
packaging of certain medicinal products fo r human use for the purposes of allowing 
their identification and authentication. 
(2) Diverging authentication mechanisms for medicinal products based on different 
national or regional traceability requiremen ts may limit the circulation of medicinal 
products across the Union and increase costs for all players in the supply chain. It is therefore necessary to establish Union-wide rules for the implementation of the safety 
features for medicinal products for human use, with particular regard to the 
characteristics and technical specifications of the unique identifier, the modalities for 
the verification of the safety features, a nd the establishment and management of the 
repository system containing inform ation on the safety features.  
(3) In accordance with Article 4 of Directive 2011 /62/EU of the European Parliament and 
of the Council
6 and Article 54a(2) and (3) of Di rective 2001/83/EC, the Commission 
has assessed the benefits, costs and cost-eff ectiveness of differen t policy options for 
the characteristics and technical specificat ions of the unique identifier, the modalities 
for the verification of the safety features and the establishment and management of the 
repository system. The policy op tions identified as the most cost-effective have been 
introduced as core elements of this Regulation. 
(4) This Regulation sets out a system where the identification and the authentication of 
medicinal products is guaranteed by an e nd-to-end verification of all medicinal 
products bearing the safety features, suppl emented by the verifica tion by wholesalers 
                                                 
5 OJ L 311, 28.11.2001, p. 67. 
6 Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending 
Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards 
the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 
1.7.2011, p. 74).  
EN 7   EN of certain medicinal products at higher risk of falsification. In pract ice, the authenticity 
and integrity of the safety features placed  on the packaging of a medicinal product at 
the beginning of the supply chain should be verified at the time the medicinal product 
is supplied to the public, although certain de rogations may apply. However, medicinal 
products at higher risk of fa lsification should be additiona lly verified by wholesalers 
throughout the supply chain, to minimise th e risk of falsified medicinal products 
circulating undetected for lengthy periods of time. The verification of the authenticity of a unique identifier should be performed by comparing th at unique identifier with 
the legitimate unique identifiers stored in a repositories system. When the pack is 
supplied to the public, or is distributed outside the Union, or in other specific 
situations, the unique identif ier on that pack should be decommissioned in the 
repositories system so any other pack beari ng the same unique identifier could not be 
successfully verified. 
(5) It should be possible to identi fy and verify the authenticity of an individual pack of a 
medicinal product for the entire time the me dicinal product stays on the market and the 
additional time necessary for returning and disp osing of the pack after it has expired.  
For this reason, the character sequence resu lting from the combination of the product 
code and the serial number sequence should be  unique to a given pack of a medicinal 
product until at least one year af ter the expiry date of that pack or five years after the 
product has been released for sale or dist ribution in accordance with Article 51(3) of 
Directive 2001/83/EC, whiche ver is the longer period. 
(6) The inclusion of the product code, the na tional reimbursement and identification 
number, the batch number and expiry date in the unique identifier contributes to 
patient safety by facilita ting recall, withdrawal an d return procedures and 
pharmacovigilance in this sector. 
(7) In order to have a negligible probability  that a serial number can be guessed by 
falsifiers, the serial number should be ge nerated according to specific randomisation 
rules. 
(8) Compliance with certain international standa rds, while not mandatory, can be used as 
proof that certain requirements of this Regulation are fulfilled. Where it is not possible to prove compliance with inte rnational standards, it will be  the responsibility of the 
persons to whom the obligations are addresse d to prove, by verifiable means, that they 
comply with those requirements. 
(9) The unique identifier shall be encoded using a standardised data structure and syntax 
so that it can be corr ectly recognised and decoded throughout the Union by 
commonly-used scanning equipment.  
(10) The global uniqueness of the product code not only contributes to the unambiguity of 
the unique identifier but also facilitates the decommissioning of a unique identifier 
when this operation takes place in a Member State different from the Member State where the medicinal product was initially intended to be placed on the market. A 
product code which conforms to certain inte rnational standards should be presumed to 
be globally unique. 
(11) To facilitate the verification of the authenticity and decommissioning of a unique 
identifier by wholesalers and persons auth orised or entitled to supply medicinal 
products to the public, it is necessary to en sure that the structur e and printing quality 
of the two-dimensional barcode encoding th e unique identifier allow for high-speed 
reading and minimisation of reading errors.  
EN 8   EN (12) The data elements of the unique identifie r should be printed on  the packaging in 
human-readable format so to allow the veri fication of the authenticity of the unique 
identifier and its decommissioning in case the two-dimensional barcode is unreadable.   
(13) A two-dimensional barcode can store more in formation than the data elements of the 
unique identifier. It should be possible to use that residual storage capacity to carry 
further information and avoid the placing of additional barcodes. 
(14) The presence of multiple two-dimensional barcodes on the packaging can engender 
confusion with regard to which barcode shoul d be read for the purpose of verifying the 
authenticity of and identifying a medicinal pr oduct. This may lead to mistakes in the 
verification of the authenticity of medici nal products and to falsified medicinal 
products being inadvertently supplied to th e public. For this reason, the presence of 
multiple two-dimensional barcodes on the packaging of a medicinal product for the purposes of identification and verification of the authenticity should be avoided.  
(15) The verification of both safety  features is necessary to ensure the authenticity of a 
medicinal product in an end-to end veri fication system. The verification of the 
authenticity of the unique identifier aims  at ensuring that the medicinal product 
originates from the legitimate manufacturer . The verification of the integrity of the 
anti-tampering device shows whether the packag ing has been opened or  altered since it 
left the manufacturer, thereby ensuring that the content of the packaging is authentic. 
(16) The verification of the authenticity of the uni que identifier is a critical step to ensure 
the authenticity of the me dicinal product bearing it and should only be based on the 
comparison with trusted information on the le gitimate unique identifiers uploaded in a 
secure repositories system by verified users. 
(17) It should be possible to revert the status  of a unique identifier that has been 
decommissioned in order to avoid the unneces sary waste of medicinal products. It is 
however necessary to subject th e reverting of the status to strict conditions to minimise 
the threat to the security of the repositories  system that such operation could generate 
if abused by counterfeiters. Those conditi ons should apply regardless of whether the 
decommissioning operation took place at the mome nt of supply to the public or at an 
earlier point in time. 
(18) Competent authorities should be able to acce ss information on the safety features of a 
medicinal product while this produc t is in the supply chain or  after it has been supplied 
to the public, recalled or withdrawn from  the market. To this end, manufacturers 
should retain records of operations with or on the unique identifier of a given 
medicinal product after the identifier has been decommissioned from the repositories 
system for a minimum of one year after the expiry date of that  medicinal product or 
five years after the pack has been released for sale or distribution in accordance with 
Article 51(3) of Directive 2001/83/EC , whichever is the longer period. 
(19) Past incidents of falsification show that  certain medicinal products, such as those 
returned by persons auth orised or entitled to  supply medicinal produc ts to the public or 
wholesalers, or medicinal products dist ributed by persons w ho are neither the 
manufacturer nor a wholesaler holding the marketing authorisat ion nor a designated 
wholesaler, are at higher risk of being fa lsified. The authenticity of those medicinal 
products should therefore be subject to additional verifications by wholesalers 
throughout the supply chain to minimise the risk that falsified products entering the legal supply chain freely circulate in the Un ion territory until they are verified at the 
time of supply to the public.   
EN 9   EN (20) The verification by wholesalers of the authenti city of medicinal pr oducts at higher risk 
of being falsified would be equally effective whether performed by scanning 
individual unique id entifiers or an aggregated code allowing the simultaneous 
verification of multiple unique  identifiers. In addition, the verification could be 
performed at any time betw een the reception of the medicinal product by the 
wholesaler and its further dist ribution, to equal results. For those reasons, it should be 
left to the choice of the wholesaler whethe r to scan individual unique identifiers or 
aggregated codes, where available, or the timing of the verification, provided that the 
wholesaler ensures the verification of all unique  identifiers of those products at higher 
risk of falsification in his physical possession, as required by this Regulation. 
(21) In the complex European supply chain, it may happen that a medicinal product 
changes ownership but remains in the physical  possession of the same wholesaler, or 
that a medicinal product is distributed with in the territory of a Member State between 
two warehouses belonging to the same wholesaler or the same  legal entity, but no sale 
takes place. In those cases, the wholesaler s should be exempted from performing a 
verification of the unique identifier as th e risk of falsification is negligible. 
(22) As a general principle, in an end-to-end verification system, the decommissioning of 
the unique identifier in the re pository system should be pe rformed at the end of the 
supply chain when the medicinal product is supplied to the public. Certain packs of 
medicinal products, however, may not eventua lly be supplied to th e public and it is 
therefore necessary to ensure their decommi ssioning at a different point of the supply 
chain. This is the case of pr oducts which, inter alia, are to  be distributed  outside the 
Union, intended for destruction, requested as  samples by competent authorities, or are 
returned products which cannot be  returned to saleable stock.  
(23) Although Directive 2011/62/EU introduced pr ovisions to regulate the sale of 
medicinal products at a distance to th e public and mandated the Commission to 
establish the modalities of verification of the safety features by persons authorised or 
entitled to supply medicinal pr oducts to the public, the supp ly of medicinal products to 
the public is still mostly re gulated at national level. Th e end of the supply chain may 
be organised differently in the different Me mber States and involve  specific healthcare 
professionals. It should be possible for the Member States to exempt specific 
institutions or persons authorised or enti tled to supply medicinal products to the public 
from the obligation of verification of the sa fety features in order to accommodate the 
particular characteristics of  the supply chain in their te rritory and ensure that the 
impact of the verification measures  on those parties is proportionate. 
(24) The verification of the authenticity of a uni que identifier is not only paramount to the 
authentication of a medicina l product but also informs the person performing the 
operation of whether that product is expi red, recalled, withdraw n or indicated as 
stolen. Persons authorised or entitled to s upply medicinal products to the public should 
verify the authenticity and decommission a unique identifier at the time the medicinal 
product is supplied to the public so to access the most up-to-date information 
concerning the product and avoid that produc ts which are expired, recalled, withdrawn 
or indicated as stolen are supplied to the public. 
(25) In order to avoid an excessive impact on th e daily operations of h ealthcare institutions, 
it should be possible for the Member States to  allow persons authorised or entitled to 
supply medicinal products to the public op erating within healthcare institutions to 
perform the verification of the authentic ity and the decommissioning of a unique  
EN 10   EN identifier earlier than the time the medici nal products is supplied to the public, or 
exempt them from this obligati on, subject to cert ain conditions. 
(26) In certain Member States, the persons auth orised or entitled to supply medicinal 
products to the public are allowed to open a pack of a medicinal product in order to 
supply part of that pack to the public. It  is therefore necessa ry to regulate the 
verification of the safety features and th e decommissioning of th e unique identifier in 
this specific situation. 
(27) The effectiveness of an end-to-end veri fication system in preventing falsified 
medicinal products from reaching the public  depends upon the systematic verification 
of the authenticity of the safety features  and the consequent decommissioning of the 
unique identifier of every supplied pack, so that that unique iden tifier cannot be re-
used by traffickers. It is th erefore important to ensure that such ope rations, should they 
not be performed at the time the medicinal product is supplied to the public due to a 
technical problem, are performed as soon as possible thereafter. 
(28) An end-to-end verification system requires the setting up of a repositories system 
which stores, inter alia, the information on the legitimate unique identifiers of a medicinal product and can be queried for the purposes of verifying the authenticity of and decommissioning a unique identifier. This repositories system should be 
established and managed by the marketing authorisation holders, since they are 
responsible for placing th e product on the market, a nd by the manufacturers of 
medicinal products bearing the safety feat ures, since they bear  the costs of the 
repositories system in accordance with Ar ticle 54a(2)(e) of Directive 2001/83/EC. 
However, wholesalers and persons authorised  or entitled to supply medicinal products 
to the public should be entitled to participat e to the establishment and management of 
the repositories system, should they wish t o, as their daily work  will depend upon the 
correct functioning of the repositories system. In addition, national competent 
authorities should be consulted in the sett ing up of the repositories system as their 
early involvement will benefit their subsequent supervision activities.  
(29) Limiting the use of the repository system shoul d not be used for th e purpose of gaining 
market advantage. For this reason, membersh ip of specific organisations should not be 
a pre-requisite for using the repository system. 
(30) The structure of the repositories system s hould be such as to ensure that medicinal 
product verification is possible throughout the Union. This may require the transfer of 
data and information on a unique identifier between repositories within the repositories systems. In order to minimi se the number of necessary connections 
between repositories and ensure their inte roperability, each nati onal and supranational 
repository part of the repositories system s hould connect to and exchange data through 
a central repository acting as information and data router. 
(31) The repositories system should comprise the necessary interfaces providing access, 
either directly or by means of software, to wholesalers, persons au thorised or entitled 
to supply medicinal products to the public and national competent authorities so that 
they can comply with  their obligations unde r this Regulation.  
(32) Given the sensitive nature of the informa tion on the legitimate unique identifiers and 
the potential negative impact on public hea lth should such information fall in the 
hands of traffickers, the responsibility for ensuring the upload of such information in 
the repositories system should be placed on the marketing authorisation holder or the 
person responsible for placing the product b earing the unique iden tifier on the market.  
EN 11   EN The information should be retained for a pe riod of time sufficiently long to allow the 
appropriate investigation of incidents of falsification. 
(33) In order to harmonise the data format and data exchange across th e repositories system 
and guarantee the interoperabili ty of the repositories as well as the readability and the 
accuracy of the transferred data, each national and supranational repository should 
exchange information and data using the data  format and data exchange specificities 
defined by the central repository. 
(34) To ensure medicinal product verificati on without hindering the movement of 
medicinal products within the single market , it should be possible for wholesalers and 
persons authorised or entitled to supply medicinal products to the public to verify the authenticity of and decommissi on a unique identifier in an y Member State, regardless 
of where in the Union the medicinal produ ct bearing that uni que identifier was 
originally intended to be placed on the ma rket. To this end, the status of a unique 
identifier should be sync hronised between repositor ies and, where necessary, 
verification queries should be redirected by the central repository to the repositories 
serving the Member States where the produc t was intended to be placed on the market. 
(35) In order to ensure that th e functioning of the repositories  system supports an end-to-
end verification of the authenticity of medi cinal products, it is necessary to set out the 
characteristics and operations of the repositories system.  
(36) The investigation of suspected or confirme d incidents of falsif ication would benefit 
from knowing as much information as possible on the produc t subject to the 
investigation. For this reason, records of all operations co ncerning a uni que identifier, 
including the users performing those opera tions and the nature of the operations 
should be stored in the repositories system, be ac cessible for the purpose of 
investigating events flagged as potential inci dents of falsification in the repositories 
system, and be made immediately availabl e to competent aut horities upon request. 
(37) In accordance with Article 54a(3) of Direc tive 2001/83/EC, it is necessary to ensure 
the protection of personal data as provided for in Union law, the legitimate interests to protect information of a commercially c onfidential nature a nd the ownership and 
confidentiality of the data ge nerated by the use of the safe ty features. For this reason, 
manufacturers, marketing authorisation holde rs, wholesalers and pe rsons authorised or 
entitled to supply medicinal products to the public should only ha ve ownership of and 
access to the data they generate when they  interact with the repositories system. 
Although the present delegated Regulation doe s not require any personal data to be 
stored in the repositories system, the protect ion of personal data should be ensured in 
case users of the repositories use the repositories system for purposes which are outside the scope of this Regulation. 
(38) The information referred to in Article 33(2)  of this Regulation and the information on 
the status of a unique identifie r should stay accessible to al l parties required to verify 
the authenticity of medicinal products, as such information is necessary for the proper 
performing of those verifications.  
(39) In order to avoid potential ambiguities and authentication errors, no unique identifiers 
having the same product code and serial num ber should be present in the repositories 
system at the same time. 
(40) In accordance with Article 54a(1) of Direct ive 2001/83/EC, medicinal products subject 
to prescription are to bear th e safety features while medi cinal products not subject to 
prescription are not allowed to. However, whether a medicinal product is subject to  
EN 12   EN prescription is most often decided nationally  and may vary across Member States. In 
addition, Member States may extend the scope of application of the safety features in 
accordance with Article 54a(5) of Direc tive 2001/83/EC. As a result, the same 
medicinal product may be required  to bear the safety featur es in one Member State but 
not in another. In order to ensure the co rrect application of th is Regulation, national 
competent authorities should, when requeste d, make available the information on the 
medicinal products placed on the market on thei r territory which shall bear the safety 
features, including those for which the scope of application of the unique identifier or 
of the anti-tampering device has been exte nded in accordance with Article 54a(5) of 
Directive 2001/83/EC, to the marketing authorisation holde rs, manufacturers, 
wholesalers and persons authorised or en titled to supply medicinal products to the 
public. 
(41) Since a repository may use servers physically  located in different Member States, or 
may be physically located in a Member Stat e which is not the Member State it serves, 
national competent authorities should be allowed to perform or observe inspections in other Member States, subject  to certain conditions.  
(42) The lists containing the medicinal products or product categories which, in the case of 
prescription medicinal products  shall not bear the safety features, and in the case of 
non-prescription medicinal products shall bear the safety features, should be 
established considering the risk of and th e risk arising from falsification of the 
medicinal products or product categories, in accordance with Article 54a(2)(b) of 
Directive 2001/83/EC, as amended. Those risk s should be assessed on  the basis of the 
criteria referred to in the said Article. 
(43) In order to avoid disruptions in the supply of medicinal produ cts, transitional measures 
for medicinal products which have been rele ased for sale or di stribution without the 
safety features before the date of applicati on of this Regulation in  the Member State or 
Member States where the product is placed on the market are necessary. 
(44) At the time of entry into force of Direct ive 2011/62/EU of the European Parliament 
and of the Council, Belgium, Greece and Ital y already had systems in place for the 
verification of the authentic ity of medicinal products and for the identification of 
individual packs. Directive 2011/62/EU granted such Member States an additional transitional period for adapting to the harm onised Union system for safety features 
introduced by that Directive for the same purposes, by allowing them to defer their 
application of the Directive as regards that  system. In order to ensure consistency 
between the national transposition measures adopted pursuant to the Directive, on the 
one hand, and  the rules of this Regulation, on the other hand, those Member States 
should be allowed the same additional tran sitional period for the application of the 
rules of this Regulation regarding that system. 
(45) In the interest of legal certainty and legal cl arity with regard to th e applicable rules in 
those Member States which benefit from  an additional transitional period in 
accordance with this Regulation, each of t hose Member States should be required to 
notify the Commission of the date from whic h  the provisions of  this Regulation 
subject to the additional tran sitional period apply in it s territory in order for the 
Commission to publish the date of a pplication in that Member State  in the Official 
Journal of the European Union  sufficiently in advance.  
EN 13   EN HAS ADOPTED THIS REGULATION: 
Chapter I 
Subject matter and definitions 
Article 1 
Subject matter 
This Regulation lays down: 
(a) the characteristics and techni cal specifications of the unique identifier that enables 
the authenticity of medicinal products to be verified and individual packs to be 
identified; 
(b) the modalities for the verification of the safety features;  
(c) the provisions on the establishment, manage ment and accessibility of the repositories 
system where the information on the sa fety features shall be contained; 
(d) the list of medicinal products and product categories subject to prescription which 
shall not bear the safety features; 
(e) the list of medicinal products and product categories not subjec t to prescription 
which shall bear the safety features; 
(f) the procedures for the notification to  the Commission by national competent 
authorities of non-prescription medicinal produc ts judged at risk of falsification and 
prescription medicinal products not deemed at risk of falsificati on in accordance with 
the criteria set out in Article 54a(2)(b) of Directive 2001/83/EC; 
(g) the procedures for a rapid evaluation of and decision on the notifications referred to 
in point (f) of this Article. 
Article 2 
Scope 
1. This Regulation applies to: 
(a) medicinal products subject to prescription which shall bear safety features on 
their packaging pursuant to Article 54a(1) of Di rective 2001/83/EC, unless 
included in the list set out in Annex I to this Regulation; 
(b) medicinal products not subject to prescr iption included in the list set out in 
Annex II to this Regulation. 
2. For the purposes of this Regulation, where re ference is made to the packaging in a 
provision of this Regulation, the provision sh all apply to outer pa ckaging or to the 
immediate packaging if the medici nal product has no outer packaging. 
Article 3 
Definitions 
1. For the purposes of this Regulation, the definitions in Article 1 of Directive 
2001/83/EC shall apply.  
EN 14   EN 2. The following definitions shall apply:  
(1) ‘unique identifier’ means the safety feature enabling the verification of the 
authenticity and the identif ication of an individual p ack of a medicinal product;  
(2) ‘anti-tampering device’ means the safety  feature allowing the verification of 
whether the packaging of a medicina l product has been tampered with; 
(3) ‘decommissioning of a unique identifier’  means the operation changing the 
active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful 
verification of the authenticity of that unique identifier; 
(4) ‘active unique identifier’ means a uni que identifier which has not been 
decommissioned or which is no longer decommissioned; 
(5) ‘active status’ means the status of an active unique identifier stored in the 
repositories system referred to in Article 31; 
(6) ‘healthcare institution’ m eans a hospital, in- or out-p atient clinic or health 
centre. 
Chapter II 
Technical specifications of the unique identifier  
Article 4 
 Composition of the unique identifier 
1. The manufacturer shall place on the packag ing of a medicinal product a unique 
identifier which complies with the following technical specifications: 
(a) The unique identifier shall be a se quence of numeric or alphanumeric 
characters that is unique to a gi ven pack of a medicinal product. 
(b) The unique identifier shall consist of the following data elements: 
(i) a code allowing the identification of at least the name, the common 
name, the pharmaceutical form, the strength, the package size and the package type of the medicinal product bearing the unique identifier (‘product code’); 
(ii) a numeric or alphanumeric se quence of maximum 20 characters, 
generated by a deterministic or a non-deterministic randomisation algorithm (‘serial number’);  
(iii) a national reimbursement number or other national number identifying 
the medicinal product, if required by the Member State where the product is intended to be placed on the market;  
(iv) the batch number; (v) the expiry date.  
(c) The probability that the serial number can be guessed shall be negligible and in 
any case lower than one in ten thousand. 
(d) The character sequence resulting from th e combination of the product code and 
the serial number shall be unique to a given pack of a medicinal product until  
EN 15   EN at least one year after the expiry date of the pack or five years after the pack 
has been released for sale or distribu tion in accordance with  Article 51(3) of 
Directive 2001/83/EC, whiche ver is the longer period. 
(e) Where the national reimbursement number or other national number 
identifying the medicinal product is cont ained in the product code, it is not 
required to be repeated within the unique identifier. 
Article 5 
Carrier of the unique identifier 
1. Manufacturers shall encode the unique iden tifier in a two-dimensional barcode. 
2. The barcode shall be a machine-readable Data Matrix and have error detection and 
correction equivalent to or higher than those of the Da ta Matrix ECC200.  Barcodes 
conforming to the International Organization for Standardization/International Electrotechnical Commission standard (‘ISO/IEC’) 16022:2006 shall be presumed to fulfil the requirements se t out in this paragraph. 
3. Manufacturers shall print th e barcode on the packaging on a smooth, uniform, low-
reflecting surface.  
4. When encoded in a Data Matrix, the struct ure of the unique identifier shall follow an 
internationally-recognised, sta ndardised data syntax and semantics (‘coding scheme’) 
which allows the identification and accurate  decoding of each data element of which 
the unique identifier is composed, using common scanning equipment. The coding 
scheme shall include data identifiers or application identifiers or other character 
sequences identifying the begi nning and the end of  the sequence of each individual 
data element of the unique identifier and defining the information contained in those 
data elements. Unique identifiers havi ng a coding scheme conforming to ISO/IEC 
15418:2009 shall be presumed to fulfil the re quirements set out in this paragraph. 
5. When encoded in a Data Matrix as data element of a unique identifier, the product 
code shall follow a coding scheme and begi n with characters specific to the coding 
scheme used. It shall also contain charac ters or character sequences identifying the 
product as a medicinal product. The resulti ng code shall be less than 50 characters 
and be globally unique. Product codes which conform to the ISO/IEC 15459-3:2014 
and ISO/IEC 15459-4:2014 shall be presumed to  fulfil the requirements set out in 
this paragraph. 
6. Where necessary, different coding schemes may be used within the same unique 
identifier provided that the decoding of th e unique identifier is not hindered. In that 
case, the unique identifier shall contain standardised characters permitting the identification of the beginning and the end of  the unique identifier as well as the 
beginning and the end of each coding sche me. Where containing multiple coding 
schemes, unique identifiers which conform to ISO/IEC 15434:2006 shall be 
presumed to fulfil the requireme nts set out in this paragraph. 
Article 6 
Quality of the printing of the two-dimensional barcode 
1. Manufacturers shall evaluate the quality of the printing of the Data Matrix by 
assessing at least the following Data Matrix parameters:  
EN 16   EN (a) the contrast between the light and dark parts; 
(b) the uniformity of the reflectance of the light and dark parts; 
(c) the axial non-uniformity; 
(d) the grid non-uniformity; 
(e) the unused error correction; 
(f) the fixed pattern damage; 
(g) the capacity of the reference decode al gorithm to decode the Data Matrix.  
2. Manufacturers shall identify the minimum qua lity of the printing which ensures the 
accurate readability of the Data Matrix th roughout the supply chain until at least one 
year after the expiry date of the pack or five years after the pack has been released 
for sale or distribution in accordance with  Article 51(3) of Directive 2001/83/EC, 
whichever is the longer period.  
3. When printing the Data Matrix, manufacturer s shall not use a quality of the printing 
lower than the minimum quality  referred to in paragraph 2. 
4. A quality of printing rated at least 1. 5 in accordance with ISO/IEC 15415:2011 shall 
be presumed to fulfil the require ments set out in this Article. 
Article 7 
Human-readable format 
1. Manufacturers shall print the following data elements of the unique identifier on the 
packaging in human-readable format:   
(a) the product code; 
(b) the serial number; 
(c) the national reimbursement number or other national numb er identifying the 
medicinal product, if required by the Member State where the product is 
intended to be placed on the market and not printed elsewhere on the packaging. 
2. Paragraph 1 shall not apply where the sum of the two lo ngest dimensions of the 
packaging equals or is infe rior to 10 centimetres.  
3. Where the dimensions of the packaging allow it, the human-readable data elements 
shall be adjacent to the two-dimensiona l barcode carrying th e unique identifier. 
Article 8 
Additional information in the two-dimensional barcode 
Manufacturers may include information othe r than the unique identifier in the two-
dimensional barcode carrying the unique identifier, where permitted by the competent authority in accordance with Ti tle V of Directive 2001/83/EU.    
Article 9 
Barcodes on the packaging   
EN 17   EN Medicinal products having to bear the safety fe atures pursuant to Arti cle 54a of Directive 
2001/83/EC shall not bear, on their packaging, any other visible two-dimensional barcode 
than the two-dimensional barcode carrying th e unique identifier for the purpose of their 
identification and verifica tion of their authenticity. 
Chapter III 
General provisions on the verifi cation of the safety features 
Article 10 
Verification of the safety features  
When verifying the safety features, manufactur ers, wholesalers and persons authorised or 
entitled to supply medicinal products to  the public shall verify the following:  
(a) the authenticity of the unique identifier;  
(b) the integrity of the anti-tampering device. 
Article 11 
Verification of the authenticity of the unique identifier  
When verifying the authenticity of a unique identifier, manufactur ers, wholesalers and 
persons authorised or entitled to supply medicinal products to  the public sh all check the 
unique identifier against the unique identifiers stored in the repositories system referred to in Article 31. A unique identifier shall be consider ed authentic when th e repositories system 
contains an active unique identifier with the pro duct code and serial numb er that are identical 
to those of the unique id entifier being verified. 
Article 12 
Unique identifiers which have been decommissioned  
A medicinal product bearing a unique identifie r which has been decommissioned shall not be 
further distributed or supplied to the public  except in any of the following situations: 
(a) the unique identifier was d ecommissioned in accordance  with Article 22(a) and 
the medicinal product is distributed for the purpose of exporting it outside the 
Union; 
(b) the unique identifier was decommissioned earlier than the time of supplying 
the medicinal product to the public, pursuant to Articles 23, 26, 28 or 41; 
(c) the unique identifier was d ecommissioned in accordance  with Article 22(b) or 
(c) or Article 40, and the medicinal product is provided  to the person 
responsible for its disposal; 
(d) the unique identifier was decommissioned in accordance with Article 22(d) and 
the medicinal product is provided to the national competent authorities. 
Article 13 
Reversing the status of a d ecommissioned unique identifier   
EN 18   EN 1. Manufacturers, wholesalers and persons aut horised or entitled to supply medicinal 
products to the public may only revert the status of a decommissioned unique 
identifier to an active status if the following conditions are fulfilled: 
(a) the person performing the reverti ng operation is covered by the same 
authorisation or entitlement and operates  in the same premises as the person 
that decommissioned the unique identifier; 
(b) the reverting of the status takes place not more than ten days after the unique 
identifier was decommissioned;  
(c) the pack of medicinal product has not expired; 
(d)  the pack of medicinal product has not been registered in the repositories 
system as recalled, withdrawn, intended for destruction or stolen and the 
person performing the reverting operat ion does not have knowledge that the 
pack is stolen;  
(e) the medicinal product has not been supplied to the public. 
2. Medicinal products bearing a unique identifie r which cannot be reverted to an active 
status because the conditions set out in paragraph 1 are not fulfilled shall not be returned to saleable stock. 
Chapter IV 
Modalities of verification of  the safety features and 
decommissioning of the unique identifier by manufacturers 
Article 14 
Verification of the tw o-dimensional barcode 
The manufacturer placing the safety features sh all verify that the two-dimensional barcode 
carrying the unique identifier complies with Articles 5 and 6, is readable and contains the correct information. 
Article 15 
Record keeping  
The manufacturer placing the sa fety features shall keep r ecords of every operation he 
performs with or on the unique identifier on a pa ck of medicinal product for at least one year 
after the expiry date of the pack or five year s after the pack has been released for sale or 
distribution in accordance with Article 51(3 ) of Directive 2001/83/EC, whichever is the 
longer period, and shall provi de those records to compet ent authorities on request. 
Article 16 
Verifications to be perfor med before removing or repl acing the safety features  
1. Before removing or covering, either fully or partially, the safety features in 
accordance with Article 47a of  Directive 2001/83/EC, the manufacturer shall verify 
the following: 
(a) the integrity of the anti-tampering device;  
EN 19   EN (b) the authenticity of the unique identifier and decommission it if replaced. 
2. Manufacturers holding both a manufacturing au thorisation accordi ng to Article 40 of 
Directive 2001/83/EC and an authorisation to manufacture or import investigational 
medicinal products to the Union as referred to in Article 61 of Regulation (EU) No 
536/2014 of the European Parl iament and of the Council7 shall verify the safety 
features and decommission the unique id entifier on a pack of  medicinal product 
before repacking or relabelling it for the purpose of using it as authorised 
investigational medicinal product or authorised aux iliary medicinal product. 
Article 17 
Equivalent unique identifier  
When placing an equivalent unique identifier for the purposes of complying with Article 
47a(1)(b) of Directive 2001/83/EC, the manufactur er shall verify that the structure and 
composition of the unique identifier placed on th e packaging complies, with regard to the 
product code and the national reimbursement numb er or other national number identifying the 
medicinal product, with the requirements of th e Member State where th e medicinal product is 
intended to be placed on the market, so that that unique identifier can be verified for 
authenticity and decommissioned. 
Article 18 
Actions to be taken by manufacturers in ca se of tampering or suspected falsification  
Where a manufacturer has reason to believe that  the packaging of the medicinal product has 
been tampered with, or the verification of the safety features shows th at the product may not 
be authentic, the manufacturer shall not release the product for sale or  distribution and shall 
immediately inform the relevant competent authorities. 
Article 19 
Provisions applicable to a manufacturer distributing hi s products by wholesale  
Where a manufacturer distributes his products by wholesale, Article 20(a), and Articles 22, 23 
and 24 shall apply to him in addition to Articles 14 to 18. 
Chapter V 
Modalities of verification of  the safety features and 
decommissioning of the unique identifier by wholesalers 
Article 20 
Verification of the authenticity of the unique identifier by wholesalers  
A wholesaler shall verify the authenticity of the unique identifier of at least the following 
medicinal products in his physical possession: 
                                                 
7 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on 
clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 
27.5.2014, p. 1).   
EN 20   EN (a) medicinal products returned to him by pe rsons authorised or entitled to supply 
medicinal products to the public  or by another wholesaler; 
(b) medicinal products he receives from  a wholesaler who is neither the 
manufacturer nor the wholesaler hold ing the marketing authorisation nor a 
wholesaler who is designated by the ma rketing authorisation holder, by means 
of a written contract, to store and distribute the products covered by his 
marketing authorisation on his behalf. 
Article 21 
Derogations from Article 20(b)  
Verification of the authenticity of the unique id entifier of a medicinal product is not required 
under Article 20(b) in any of  the following situations: 
(a) that medicinal product changes owne rship but remains in the physical 
possession of the same wholesaler; 
(b) that medicinal product is distributed w ithin the territory of a Member State 
between two warehouses belonging to the same wholesaler or the same legal 
entity, and no sale takes place. 
Article 22 
Decommissioning of unique identifiers by wholesalers  
Wholesalers shall verify the authenticity of and decommission the unique identifier of the 
following medicinal products: 
(a) products which he intends to dist ribute outside of the Union; 
(b) products which have been returned to hi m by persons authorised or entitled to 
supply medicinal products to the public or  another wholesaler and cannot be 
returned to saleable stock; 
(c) products which are intended for destruction; 
(d) products which, while in his physical posse ssion, are requeste d as a sample by 
competent authorities;  
(e) products which he intends to distribute to  the persons or institutions referred to 
in Article 23, where required by nationa l legislation in accordance with the 
same Article. 
Article 23 
Provisions to accommodate specific characte ristics of Member States’ supply chain  
Member States may require, where necessary to  accommodate the particular characteristics of 
the supply chain on their terri tory, that a wholesaler verifi es the safety features and 
decommissions the unique identifier of a medici nal product before he su pplies that medicinal 
product to any of the following persons or institutions: 
(a) persons authorised or entitled to suppl y medicinal products to the public who 
do not operate within a healthcare institution or within a pharmacy;  
(b) veterinarians and retailers of veterinary medicinal products;  
EN 21   EN (c) dental practitioners; 
(d) optometrists and opticians; 
(e) paramedics and emergency medical practitioners; 
(f) armed forces, police and other governmental institutions maintaining stocks of 
medicinal products for the purposes of ci vil protection and disaster control; 
(g) universities and other higher educati on establishments using medicinal 
products for the purposes of  research and education,  with the exceptions of 
healthcare institutions; 
(h) prisons; 
(i) schools; 
(j) hospices; 
(k) nursing homes. 
Article 24 
Actions to be taken by wholesalers in ca se of tampering or suspected falsification  
A wholesaler shall not supply or export a medi cinal product where he has reason to believe 
that its packaging has been tampered with, or wh ere the verification of the safety features of 
the medicinal product indicates that the product  may not be authentic. He shall immediately 
inform the relevant competent authorities. 
Chapter VI 
Modalities of verification of  the safety features and 
decommissioning of the unique identi fier by persons authorised or 
entitled to supply medicina l products to the public 
Article 25 
Obligations of persons authorised or entitle d to supply medicinal products to the public  
1. Persons authorised or entitled to supply me dicinal products to the public shall verify 
the safety features and decommission the unique identifier of any medicinal product 
bearing the safety features th ey supply to the public at the time of supplying it to the 
public. 
2. Notwithstanding paragraph 1, persons author ised or entitled to supply medicinal 
products to the public operating within a healthcare institution may carry out that 
verification and decommissioning at any time the medicinal product is in the 
physical possession of the healthcare institution, provided that no sale of the medicinal product takes place between the de livery of the product to the healthcare 
institution and the suppl ying of it to the public. 
3. In order to verify the auth enticity of the unique  identifier of a medicinal product and 
decommission that unique identifier, pers ons authorised or entitled to supply 
medicinal products to the public  shall connect to the repos itories system referred to 
in Article 31 through the national or supran ational repository serv ing the territory of 
the Member State in which they are authorised or entitled.  
EN 22   EN 4. They shall also verify the safety features and decommission the un ique identifier of 
the following medicinal products bearing the safety features: 
(a) medicinal products in their physical possession that cannot be returned to 
wholesalers or manufacturers; 
(b) medicinal products that, while in their physical possession, are requested as 
samples by competent authorities, in accordance with national legislation; 
(c) medicinal products which they supply for subsequent use as authorised 
investigational medicinal products or authorised a uxiliary medicinal products 
as defined in Articles 2(2)(9) and (10) of Regulation (EU) No 536/2014. 
Article 26 
Derogations from Article 25 
1. Persons authorised or entitled to suppl y medicinal products to the public are 
exempted from the obligation to verify the safety features and decommission the 
unique identifier of medicinal products pr ovided to them as free samples in 
accordance with Article 96 of Directive 2001/83/EC. 
2. Persons authorised or entitled to supply medicinal products to the public who do not 
operate within a healthcare institution or within a pharmacy are exempted from the 
obligation to verify the safety features an d decommission the un ique identifier of 
medicinal products where that obligation has been placed on wholesalers by national legislation in accordance with Article 23. 
3. Notwithstanding Article 25, Member Stat es may decide, where necessary to 
accommodate the particular characteristics of the supply chain on their territory, to 
exempt a person authorised or entitled to  supply medicinal products to the public 
operating within a healthcare institution fr om the obligations of verification and 
decommissioning of the unique identifier, pr ovided that the following conditions are 
met:  
(a) the person authorised or entitled to supply medicina l products to the public 
obtains the medicinal product bear ing the unique identifier through a 
wholesaler belonging to the same legal entity as the heal thcare institution;  
(b) the verification and decommissioning of the unique identifier is performed by 
the wholesaler that supplies the prod uct to the healthcare institution;  
(c) no sale of the medicinal product takes place between the wholesaler supplying 
the product and that h ealthcare institution; 
(d) the medicinal product is supplied to the public within that healthcare 
institution. 
Article 27 
Obligations when applying the derogations 
Where the verification of the authenticity a nd decommissioning of th e unique identifier is 
carried out earlier than referred to in Article 25(1), pursuant to Articles 23 or 26, the integrity 
of the anti-tampering devi ce shall be verified at the time the medicinal product is supplied to 
the public.  
EN 23   EN Article 28 
Obligations when supplying only part of a pack 
Notwithstanding Article 25(1), wh ere persons authorised or entitled to supply medicinal 
products to the public supply only part of a p ack of a medicinal produc t the unique identifier 
of which is not decommissioned, they shall veri fy the safety features and decommission that 
unique identifier when the pack is opened for the first time. 
Article 29 
Obligations in case of inability to verify  the authenticity and decommission the unique 
identifier 
Notwithstanding Article 25(1), where technical  problems prevent persons authorised or 
entitled to supply medicinal produ cts to the public from veri fying the authen ticity of and 
decommissioning a unique identifier at the time the medicinal product bearing that unique 
identifier is supplied to the public, persons author ised or entitled to supply medicinal products 
to the public shall record the unique identifier  and, as soon as the technical problems are 
solved, verify the authenticity of a nd decommission the unique identifier.    
Article 30 
Actions to be taken by persons authorised or entitled to supply me dicinal products to the 
public in case of suspected falsification  
Where persons authorised or entitled to suppl y medicinal products to the public have reason 
to believe that the packaging of the medici nal product has been tampered with, or the 
verification of the safety feat ures of the medicinal product i ndicates that the product may not 
be authentic, persons authorised  or entitled to supply medicina l products to the public shall 
not supply the product and shall immediately in form the relevant competent authorities. 
Chapter VII 
Establishment, management and accessibility of the repositories 
system 
Article 31 
Establishment of the repositories system  
1. The repositories system where the inform ation on the safety features shall be 
contained, pursuant to Article 54a(2)(e) of  Directive 2001/83/EC, shall be set up and 
managed by a non-profit legal entity or non -profit legal entities established in the 
Union by manufacturers and ma rketing authorisation holde rs of medicinal products 
bearing the safety features. 
2. In setting up the repositories system, the legal entity or entities referred to in 
paragraph 1 shall consult at least wholesal ers, persons authorised or entitled to 
supply medicinal products to the public and relevant national competent authorities.   
3. Wholesalers and persons author ised or entitled to supply medicinal products to the 
public are entitled to participate in the legal entity or entities refe rred to in paragraph 
1, on a voluntary basis, at no cost.  
EN 24   EN 4. The legal entity or entities referred to on paragraph 1 shall not require manufacturers, 
marketing authorisation holders, wholesaler s or persons authorised or entitled to 
supply medicinal products to th e public to be members of a specific organisation or 
organisations in order to use the repository system. 
5. The costs of the repositories system shall be borne by the manufacturers of medicinal 
products bearing the safety features, in  accordance with Article 54a(2)(e) of 
Directive 2001/83/EC. 
Article 32 
Structure of the repositories system  
1. The repositories system shall be composed  of the following electronic repositories: 
(a) a central information and data router (‘hub’);  
(b) repositories which serve the territory  of one Member State ("national 
repositories") or the territory of multiple Member States ("supranational repositories"). Those repositories  shall be connect ed to the hub. 
2. The number of national and supr anational repositories shall be sufficient to ensure 
that the territory of every Member State is served by one national or supranational 
repository. 
3. The repositories system shall comprise  the necessary information technology 
infrastructure, hardware and software to en able the execution of the following tasks: 
(a) upload, collate, process, m odify and store the informa tion on the safety features 
that enables the verificati on of the authenticity and identification of medicinal 
products; 
(b) identify an individual pack of a medici nal product bearing the safety features 
and verify the authenticity of the uni que identifier on that pack and 
decommission it at any point of the legal supply chain. 
4. The repositories system shall include the application programming interfaces 
allowing wholesalers or persons authorised or entitled to supply medicinal products 
to the public to query the repositories syst em by means of software, for the purposes 
of verifying the authenticity of the uni que identifiers and of decommissioning them 
in the repositories system. The application programming interfaces shall also allow national competent authorities to access the repositories system by means of 
software, in accordance with Article 39. 
The repositories system shall also include graphic user interfaces providing direct 
access to the repositories system in accordance with Article 35(1)(i).  
The repositories system shall not include the physical scanning equipment used for 
reading the unique identifier.  
Article 33 
Uploading of information in  the repositories system  
1. The marketing authorisation holder or, in case of parallel im ported or parallel 
distributed medicinal products bearing an  equivalent unique identifier for the 
purposes of complying with Article 47a  of Directive 2001/83/EC, the person 
responsible for placing th ese products on the market, shall ensure that the  
EN 25   EN information referred to in paragraph 2 is uploaded to the repositories system before 
the medicinal product is released for sale or distribution by th e manufacturer, and 
that it is kept up to date thereafter. 
The information shall be stored in all na tional or supranational repositories serving 
the territory of the Member State or Me mber States where the medicinal product 
bearing the unique identifier is intended to be placed on the market. The information 
referred to in paragraphs 2(a) to (d) of th is Article, with the exception of the serial 
number, shall also be stored in the hub. 
2. For a medicinal product bearing a unique  identifier, at least the following 
information shall be uploaded to the repositories system: 
(a) the data elements of the unique iden tifier in accordance with Article 4(b); 
(b) the coding scheme of the product code; 
(c) the name and the common name of the medicinal product, the pharmaceutical 
form, the strength, the package type a nd the package size of the medicinal 
product, in accordance with the terminol ogy referred to in Article 25(1)(b) and 
(e) to (g) of the Commission Impl ementing Regulation (EU) No 520/20128; 
(d) the Member State or Member States where the medicinal product is intended to 
be placed on the market; 
(e) where applicable, the code identifying the entry corresponding to the medicinal 
product bearing the unique identifier in the database referred to in Article 
57(1)(l) of Regulation (EU)  No 726/2004 of the European Parliament and the 
Council9; 
(f) the name and address of the manufac turer placing the safety features; 
(g) the name and address of the ma rketing authorisation holder; 
(h) a list of wholesalers who are designated by the marketing authorisation holder, 
by means of a written contract, to stor e and distribute the products covered by 
his marketing authorisation on his behalf. 
3. The information referred to in paragraph 2 shall be uploaded to the repositories 
system either through the hub or through a national or supranational repository.  
Where the upload is performed through th e hub, the hub shall store a copy of the 
information referred to in paragraph 2(a) to  (d), with the exception of the serial 
number, and transfer the complete inform ation to all national or supranational 
repositories serving the territory of the Me mber State or Member States where the 
medicinal product bearing the unique identi fier is intended to be placed on the 
market. 
Where the upload is performed through a na tional or supranational repository, that 
repository shall immediately transfer to th e hub a copy of the information referred to 
                                                 
8 Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of 
pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament 
and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L 159, 
20.6.2012, p. 5). 
9 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down Community procedures for the authorisation and supervision of medicinal products for human 
and veterinary use and establishing a European Medicines Agency  (OJ L 136, 30.4.2004, p. 1).  
EN 26   EN in paragraph 2(a) to (d), with the excep tion of the serial number, using the data 
format and data exchange specifications defined by the hub. 
4. The information referred to in paragraph 2 sh all be stored in the repositories where it 
was originally uploaded for at least one year  after the expiry date of the medicinal 
product or five years after th e product has been released for sale or distribution in 
accordance with Article 51(3)  of Directive 2001/83/EC, whichever is the longer 
period. 
Article 34 
Functioning of the hub 
1. Each national or supranational repository composing the repositories system shall 
exchange data with the hub using the da ta format and data exchange modalities 
defined by the hub. 
2. When the authenticity of the unique identi fier cannot be verified because a national 
or supranational repository does not contain a unique identifier with the product code 
and serial number that are id entical to those of the uni que identifier be ing verified, 
the national or supranational repository shall transfer the query to the hub in order to 
verify whether that unique iden tifier is stored elsewhere in the repositories system.  
When the hub receives the query, the hub  shall identify, on the basis of the 
information contained therein,  all national or supranati onal repositories serving the 
territory of the Member State or Member States where the medicinal product bearing 
the unique identifier was intended to be pl aced on the market, and shall transfer the 
query to those repositories. 
The hub shall subsequently transfer the repl y of those repositories to the repository 
which initiated the query. 
3. Where notified by a national or supranational repository of the change of status of a 
unique identifier, the hub shall ensure the synchronisation of that status between 
those national or supranational repositories serving the territory of the Member State 
or Member States where the medicinal product bearing the unique identifier was 
intended to be placed on the market. 
4. When it receives the information referred to in Article 35(4 ), the hub shall ensure the 
electronic linking of the batch numbers before  and after the repacking or relabelling 
operations with the set of unique identifi ers decommissioned and with the set of 
equivalent unique identifiers placed. 
Article 35 
Characteristics of the repositories system  
1. Each repository in the repositories system shall satisfy all of the following 
conditions:  
(a) it shall be physically located in the Union; 
(b) it shall be set up and managed by a non-profit legal entity established in the 
Union by manufacturers and marketing authorisation hold ers of medicinal 
products bearing the safety features and, wh ere they have chosen to participate, 
wholesalers and persons authorised or entitled to supply medicinal products to 
the public;  
EN 27   EN (c) it shall be fully interoperable with the other repositories composing the 
repositories system; for the purposes of th is Chapter, interoperability means the 
full functional integration of, and electronic data exchange between 
repositories regardless of the service provider used; 
(d) it shall allow the reliable electronic  identification and authentication of 
individual packs of medi cinal products by manufact urers, wholesalers and 
persons authorised or entit led to supply medicinal pr oducts to the public, in 
accordance with the requiremen ts of this Regulation; 
(e) it shall have application pr ogramming interfaces able to  transfer and exchange 
data with the software used by wholesaler s, persons authorised  or entitled to 
supply medicinal products to the pub lic and, where applicable, national 
competent authorities; 
(f) when wholesalers and persons authoris ed or entitled to supply medicinal 
products to the public query the reposito ry for the purposes of verification of 
authenticity and decommissioning of a uni que identifier, the response time of 
the repository, not consider ing the speed of the inte rnet connection, shall be 
lower than 300 milliseconds in at leas t 95% of queries. The repository 
performance shall allow wholesalers a nd persons authorised or entitled to 
supply medicinal products to the public to  operate without significant delay;  
(g) it shall maintain a complete record (‘a udit trail’) of all ope rations concerning a 
unique identifier, of the us ers performing those operations  and the nature of the 
operations; the audit trail shall be created when the unique identifier is 
uploaded to the repository and be mainta ined until at least one year after the 
expiry date of the medicinal product bear ing the unique identifi er or five years 
after the product has been released for sale or distribution in accordance with 
Article 51(3) of Directive 2001/83/EC, whichever is the longer period;  
(h) in accordance with Article 38, its structur e shall be such as to guarantee the 
protection of personal data and inform ation of a commercially confidential 
nature and the ownership and confidentiality of the data generated when manufacturers, marketing authorisa tion holders, wholesalers and persons 
authorised or entitled to supply medicina l products to the pub lic interact with 
it; 
(i) it shall include graphic user interfaces providing direct access to it to the 
following users verified in accordance with Article 37(b): 
(i) wholesalers and persons authorised  or entitled to supply medicinal 
products to the public, for the purposes of verifying the authenticity of 
the unique identifier and decommissioning it in cas e of failure of their 
own software; 
(ii) national competent authorities, for the purposes referred to in Article 39; 
2. Where the status of a unique identifier on a medicinal product intended to be placed 
on the market in more than one Member St ate changes in a national or supranational 
repository, that repository shall immediately notify the change of status to the hub, 
except in case of decommissioning by marke ting authorisation holders in accordance 
with Articles 40 or 41.  
EN 28   EN 3. National or supranational re positories shall not allow th e upload or storage of a 
unique identifier containing the same product code and serial number as another 
unique identifier alr eady stored therein. 
4. For each batch of repacked or relabelle d packs of a medicinal product on which 
equivalent unique identifiers were placed for the purposes of complying with Article 
47a of Directive 2001/83/EC, the person re sponsible for placing the medicinal 
product on the market shall inform the hub of  the batch number or numbers of the 
packs which are to be repacked or relabe lled and of the unique identifiers on those 
packs. He shall additionally inform th e hub of the batch number of the batch 
resulting from the repacking or relabellin g operations and the equivalent unique 
identifiers in that batch. 
Article 36 
Operations of the repositories system  
The repositories system shall provide for at least the following operations: 
(a) the repeated verification of the authenticity of an active unique identifier in 
accordance with Article 11; 
(b) the triggering of an alert in the sy stem and in the terminal where the 
verification of the authenticity of a unique identifier is taking place when such 
verification fails to confirm that the uni que identifier is authentic in accordance 
with Article 11. Such an event shall be  flagged in the system as a potential 
incident of falsification except where the product is i ndicated in the system as 
recalled, withdrawn or in tended for destruction; 
(c) the decommissioning of a unique iden tifier in accordance with the 
requirements of this Regulation; 
(d) the combined operations of identifica tion of a pack of a medicinal product 
bearing a unique identifier and veri fication of the authenticity and 
decommissioning of that unique identifier; 
(e) the identification of a pack of a medi cinal product beari ng a unique identifier 
and the verification of the authenticity and the decommissioning of that unique 
identifier in a Member State which is not the Member State where the medicinal product bearing that unique identifier was placed on the market; 
(f) the reading of the information contai ned in the two-dimensional barcode 
encoding the unique identifier, the id entification of the medicinal product 
carrying the barcode and the verification of the status of the unique identifier , 
without triggering the alert referred to in point (b) of this Article; 
(g) without prejudice to Article 35(1)(h), th e access by verified wholesalers to the 
list of wholesalers referred to in Article 33(2)(h) for the purposes of 
determining whether they have to verify the unique identifier of a given medicinal product. 
(h) the verification of the authentic ity of a unique identifier and its 
decommissioning by manually querying the sy stem with the data elements of 
the unique identifier;   
EN 29   EN (i) the immediate provision of information c oncerning a given unique identifier to 
the national competent authorities a nd the European Medicines Agency, upon 
request; 
(j) the creation of reports that  allow competent authorities to verify compliance of 
individual marketing authorisation hol ders, manufacturers, wholesalers and 
persons authorised or entit led to supply medicinal pr oducts to the public with 
the requirements of this Regulation or to investigate potential incidents of falsification;  
(k) the reverting of the status of a uni que identifier from decommissioned to 
active, subject to the conditions referred to in Article 13; 
(l) the indication that a unique iden tifier has been decommissioned; 
(m) the indication that a medicinal product has been recalled, withdrawn, stolen, 
exported, requested as a sample by nationa l competent authorities, indicated as 
a free sample by the marketing authoris ation holder, or is intended for 
destruction; 
(n) the linking, by batches of medicinal products, of the information on unique 
identifiers removed or covered to the information on the equivalent unique 
identifiers placed on those medicinal products for the purposes of complying with Article 47a of Directive 2001/83/EC. 
(o) the synchronisation of the status of a unique identifier between the national or 
supranational repositories se rving the territory of the Member States where that 
medicinal product is intended to be placed on the market. 
Article 37 
Obligations of legal entities establishing and managing a repository  which is part of the 
repositories system  
Any legal entity establishing and managing a repository which is part of the repositories 
system shall perform the following actions: 
(a) inform the relevant national competent authorities of its intention to physically 
locate the repository or part of it in their territory and notify them once the repository becomes operational; 
(b) put in place security pro cedures ensuring that only us ers whose identity, role 
and legitimacy has been verified can access the repository or upload the information referred to in Article 33(2); 
(c) continuously monitor the repos itory for events alerting to  potential incidents of 
falsification in accordance to Article 36(b);  
(d) provide for the immediate investigation of  all potential incidents of falsification 
flagged in the system in accordance with Article 36(b) and for the alerting of national competent authorities, the European Medicines Agency and the 
Commission should the falsif ication be confirmed; 
(e) carry out regular audits of the repos itory to verify compliance with the 
requirements of this Regulation. Audits sh all take place at le ast annually for the 
first five years after this Regulation b ecomes applicable in the Member State 
where the repository is phys ically located, and at least every three years  
EN 30   EN thereafter. The outcome of those aud its shall be provided to competent 
authorities upon request; 
(f) make the audit trail referred to in Article 35(1)(g) immediately available to 
competent authorities upon their request; 
(g) make the reports referred to in Article 36(j) available to competent authorities 
upon their request.  
Article 38 
Data protection and data ownership  
1. Manufacturers, marketing authorisation holde rs, wholesalers and persons authorised 
or entitled to supply medicina l products to the public sh all be responsible for any 
data generated when they interact with the repositories system and stored in the audit 
trail. They shall only have  ownership of and access to those data, with the exception 
of the information referred to in Article 33 (2) and the information on the status of a 
unique identifier. 
2. The legal entity managing the repository wh ere the audit trail is stored shall not 
access the audit trail and the da ta contained therein withou t the written agreement of 
the legitimate data owners except for the purpose of investigating potential incidents 
of falsification flagged in the syst em in accordance with Article 36(b). 
Article 39 
Access by national competent authorities  
A legal entity establishing and managing a repos itory used to verify the authenticity of or 
decommission the unique identifiers of medicina l products placed on the market in a Member 
State shall grant access to that repository an d to the information contained therein, to 
competent authorities of that Memb er State for the following purposes: 
(a) supervising the functioning of the repos itories and investigating potential 
incidents of falsification; 
(b) reimbursement;  
(c) pharmacovigilance or pharmacoepidemiology. 
Chapter VIII 
Obligations of marketing au thorisation holders, parallel 
importers and parallel distributors 
Article 40 
Products recalled, withdrawn or stolen  
The marketing authorisation holder or, in case of parallel imported or parallel distributed 
medicinal products bearing an eq uivalent unique identifier for th e purposes of complying with 
Article 47a of Directive 2001/83/ EC, the person responsible for placing the medicinal product 
on the market shall promptly take all the following measures:  
EN 31   EN (a) ensure the decommissioning of the uni que identifier of a medicinal product 
which is to be recalled or withdraw n, in every national or supranational 
repository serving the territory of the Member State or Member States in which the recall or the withdrawal is to take place;  
(b) ensure the decommissioning of the uni que identifier, wh ere known, of a 
medicinal product which has been stolen, in every national or supranational 
repository in which informati on on that product is stored;  
(c) indicate in the repositories referred to in  points (a) and (b) that that product has 
been recalled or withdrawn or stolen, where applicable. 
Article 41 
Products to be supplied as free samples  
The marketing authorisation holder  intending to supply any of hi s medicinal products as a free 
sample in accordance with Article 96 of Direc tive 2001/83/EC shall, where that product bears 
the safety features, indicate it as a free sample  in the repositories system and ensure the 
decommissioning of its unique identifier before  providing it to the persons qualified to 
prescribe it. 
Article 42 
Removal of unique identifiers from the repositories system  
The marketing authorisation holde r of a medicinal product or, in case of parallel imported or 
parallel distributed medicinal products bearing an equivalent  unique identifier for the 
purposes of complying with Article 47a of Di rective 2001/83/EC, the person responsible for 
placing the medicinal product on  the market shall not uploa d unique identifiers in the 
repositories system before having remove d from therein, where present, older unique 
identifiers containing the same product code an d serial number as the unique identifiers being 
uploaded.  
Chapter IX 
Obligations of the national competent authorities 
Article 43 
Information to be provided by  national competent authorities  
National competent authorities shall make th e following information available to the 
marketing authorisation holders , manufacturers, w holesalers and persons authorised or 
entitled to supply medicinal products  to the public, upon their request:   
(a) the medicinal products placed on the mark et on their territory  which shall bear 
the safety features in accordance with  Article 54(o) of Directive 2001/83/EC 
and this Regulation; 
(b) the medicinal products subject to prescr iption or subject to reimbursement for 
which the scope of the uni que identifier is extende d for the purposes of 
reimbursement or pharmacovigilance, in  accordance with Article 54a(5) of 
Directive 2001/83/EC;  
EN 32   EN (c) the medicinal products for which the scope of the anti-tampering device is 
extended for the purpose of patient safety, in accordance with Article 54a(5) of 
Directive 2001/83/EC.  
Article 44 
Supervision of the repositories system  
1. National competent authorities shall supervise the functioning of any repository 
physically located in their territory, in or der to verify, if n ecessary by means of 
inspections, that the repository and the lega l entity responsible for the establishment 
and management of the repository comply with the requirements of this Regulation. 
2. A national competent authority may delegate any of its obligations under this Article 
to the competent authority of another Member  State or to a third party, by means of a 
written agreement. 
3. Where a repository not physica lly located in the territory of a Memb er State is used 
for the purpose of verifying the authentic ity of medicinal products placed on the 
market in that Member State, the compet ent authority of that Member State may 
observe an inspection of the repository or perform an i ndependent inspection, subject 
to the agreement of the Member State in which the repository is physically located. 
4. A national competent authority shall communi cate reports of supervision activities to 
the European Medicines Agency, which sh all make them available to the other 
national competent author ities and the Commission. 
5. National competent authorities may contribu te to the management of any repository 
used to identify medicinal pr oducts and verify the authen ticity of or decommission 
the unique identifiers of medicinal products  placed on the market in the territory of 
their Member State.  
National competent authorities may participat e to the management board of the legal 
entities managing those repositor ies to the extent of up to one third of the members 
of the board. 
Chapter X 
Lists of derogations and noti fications to the Commission 
Article 45 
Lists of derogations from bearing or not bearing the safety features  
1. The list of medicinal products or product categories subject to  prescription which 
shall not bear the safety features are set out in A nnex I to this Regulation. 
2. The list of medicinal products or product ca tegories not subject to prescription which 
shall bear the safety f eatures are set out in A nnex II to this Regulation. 
Article 46 
Notifications to the Commission  
1. National competent authorit ies shall notify the Commi ssion of non-prescription 
medicinal products which they judge to be at  risk of falsifica tion as soon as they  
EN 33   EN become aware of such risk.  For that pur pose, they shall use the form set out in 
Annex III to this Regulation.  
2. National competent authorities may inform  the Commission of medicinal products 
which they deem not to be at risk of falsif ication. For that purpose, they shall use the 
form set out in Annex IV to this Regulation. 
3. For the purposes of the notif ications referred to in paragraphs 1 and 2, national 
competent authorities shall c onduct an assessment of the risks of and arising from 
falsification of such products taking in to account the criteri a listed in Article 
54a(2)(b) of Directive 2001/83/EC. 
4. When submitting to the Commission the no tification referred to in paragraph 1, 
national competent authorities shall provi de the Commission with evidence and 
documentation supporting the presence of incidents of falsification. 
Article 47 
Evaluation of the notifications  
Where, following a notification as referred to in Article 46, the Commission or a Member 
State considers, on the basis of casualties or hospitalisations of citizens of the Union due to 
exposure to falsified medicinal pr oducts, that rapid ac tion is required to pr otect public health, 
the Commission shall asses the notification with out delay and at the latest within 45 days.    
Chapter XI 
Transitional measures and entry into force  
Article 48 
Transitional measures 
Medicinal products that have been  released for sale or distribu tion without the safety features 
in a Member State before the date in which this Regulation becomes applicable in that Member State, and are not repacked or relabe lled thereafter, may be  placed on the market, 
distributed and supplied to the public in th at Member State until their expiry date. 
Article 49 
Application in Member States wi th existing systems for the verification of the authenticity of 
medicinal products and for the id entification of individual pack s 
1. Each of the Member States referred to in Article 2, paragraph 2, second 
subparagraph, point (b), second sentence, of Directive 2011/62/ EU shall notify the 
Commission of the date from which Articles 1 to 48 of this Regulation apply in its 
territory in accordance with the third s ubparagraph of Article 50. The notification 
shall take place at the latest 6 m onths before that application. 
2. The Commission shall publish a notice of each of the dates notified to it in 
accordance with paragraph 1 in the Offi cial Journal of the European Union. 
  
EN 34   EN Article 50 
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 . 
It shall apply from [3 years after publication]. 
However, the Member States referred to in Article 2, paragraph 2, s econd subparagraph, point 
(b), second sentence, of Direct ive 2011/62/EU shall apply Articl es 1 to 48 of this Regulation 
at the latest from [9 years after publication]. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  […]