EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 17.12.2021  
C(2021) 9700 final  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of 17.12.2021  
amending Delegated Regulation (EU) 2016/161 as regards the derogation from the 
obligation of wholesalers to decommission the unique identifier of medicinal products 
exported to the United Kingdom  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
On 1 February 2020, the United Kingdom withdrew  from the European Union and 
became a ‘third country’1. The Withdrawal Agreement2 provided for a transition 
period ending on 31 December 2020. Until that date, EU law in its entirety applie d to 
and in the United Kingdom3. 
The safety features (namely an anti-tampering device and unique identifier) are 
mandatory for prescription  medicinal products placed on the market in the EU, as 
laid down in Articles 54(o) and 54a(1) of Directive 2001/83/EC and in Commission 
Delegated Regulation (EU) 2016/161 . Furthermore, unique identifiers must be 
uploaded to a repository system that allows the authenticity of medicines to be 
verified by manufacturers, wholesalers and persons entitled to supply medicines to 
the public.  
According to the Protocol on Ireland/ Northern Ireland , Directive 2001/83 /EC is 
applicable to an d in the United Kingdom in respect of Northern Ireland . Therefore, 
the safety features laid down in Articles 54(o) and 54a(1) of Directive 2001/83/EC 
apply to medicinal products placed on the market in Northern Ireland.  
Without prejudice to the application  of this legislation to and in the United Kingdom 
in respect of Northern Ireland, the placing on the market of medicinal products in any 
other part of the United Kingdom does not require the placement  of safety features  
on prescription medicines .  
This has mean t that, from 1 January 2021, prescription  medicines destined for parts 
of the United Kingdom other than Northern Ireland  do not have the same 
requirements regarding safety features as medicines destined for Northern Ireland, 
Cyprus, Ireland or  Malt a, even where the supply route goes through Great Britain. 
Medicines intended for the Northern Irish, Cypriot, Irish  and Maltese markets must 
carry safety features uploaded in the EU repository system . This is not the case for 
medicines  with a final destin ation in any other part of the United Kingdom than 
Northern Ireland.  
To prevent the reintroduction of exported medicines into the EU single  market, 
Article 22 (a) of Commission Delegated Regulation (EU) 2016/161 obliges 
wholesalers to decommission the uniq ue identifier on all medicines they  export 
outside the EU before  they are export ed. If exported medicines are subsequently 
reimported into the EU, the requirements for importation under Directive 
2001/83/EC must be met and a new unique identifier affixed a nd uploaded to the 
repositories system . These operations can only be performed by the holder of a 
manufacturing and importation authorisation.  
On 1 January 2021, a derogation from the requirement to decommission the unique 
identifier on medicines exported to the United Kingdom was granted for one year. 
                                                 
1 A third country is a country that is not a member of the EU . 
2 Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the 
European Union and the European Atomic Energy Community, OJ L 29, 31.1.2020, p. 7 (“Withdrawal 
Agreement”).  
3 Subject to certain exceptions provided for in Art icle 127 of the Withdrawal Agreement, none of which 
is relevant in the context of this Regulation . EN 2  EN This was to prevent supply disruptions in Northern Ireland, Cyprus, Ireland  and 
Malta . In these markets, many medicines were purchased from the U nited Kingdom  
by wholesalers not holding a manufacturing and importation authorisation and 
therefore unable to meet the importation requirements laid down in Directive 
2001/83/EC and Delegated Regulation (EU) 2016/ 161.  
According to information received by the European Commission, these markets 
continue to be disproportionately dependent on the U nited Kingdom  market  for 
medicines . At the same time, waiving the requirement to decommission the unique 
identifier on medicines when exported to the U nited Kingdom  without appropriate 
safeguards creates a ri sk of falsification and reintroduction of these medicines into 
the markets of EU Member States  other than Cyprus, Ireland and Malta .  
The presence of a unique identifier on the medicinal products imported into Northern 
Ireland, Cyprus , Ireland and Malta through Great Britain is an essential requirement 
for ensuring a high level of public health protection in those countries, and this 
presence can as yet only be achieved by means of wholesale rs located in the EU not 
decommissioning the unique ide ntifier o n medicinal products.  
For these reasons , the Commission has decided to continue to waive the obligation to 
decommission the unique identifier when medicines  are distributed to the United 
Kingdom for a period of three years , to ensure the supply of  medicines in  small 
markets dependent on the U nited Kingdom . This is coupled with further safeguards 
to ensure that these medicines are not reintroduced into other EU markets  by 
identifying United Kingdom  packs as such in the repository system . The 
Commission will monitor the functioning of th is derogation and the supply of 
medicines to the small markets dependent on the U nited Kingdom  for its duration,  
and consider, where necessary, appropriate measures.   
The amendment also clarifies that the geogra phical scope of the repository system is 
the European Economic Area and that repositories outside the EU should not be 
connected to the system. This is to ensure , given  the limited means of supervision, 
that such entities are not able to upload and access sensitive content in the system.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The European Commission presented the proposed amendment to the European 
Commission Expert Group ‘Delegated act on safety features for medicinal products 
for human use ’ at a meeting on 1 September 2021. It received a generally positive 
opinion during a written consultation of the Expert Group from 16 to 28 September 
2021 .  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The definition of an ‘active unique identifier’ in Article 3 of Delegated Regulation 
(EU) 2016/161  is amended to exclude unique identifiers on medicines intended for 
the U nited Kingdom  market and scanned in a Member State  other than Cyprus, 
Ireland and Malta .  
Article 20 is amended to require wholesale rs to verify the presence of the safety 
features on shipments received from manufacturers, marketing authorisation holders 
and designated wholesalers.  EN 3  EN Article 22(a) is amended to exceptionally extend the derogation from the obligation 
to decommission the unique identifier  when medicinal products are exported to the 
United Kingdom  for a further three  years .  
Article 26 is amended to allow the U nited Kingdom  supervisory authority the 
possibility to waive the requirement to decommission  the unique identifier on  
medicines supp lied to the entities listed in Article 23 for three years.  
Article 32(1), point b, is amended to clarify that repositories outside the European 
Economic Area cannot be connected to the EU repository system.  
Article 36 is amended to require that medicines  intended for the U nited Kingdom  
with respect to  the Northern Ir ish market or multiple markets including  Cyprus, 
Ireland or Malta,  and the United Kingdom  with respect to Northern Ireland , generate 
an alert when scanned in another Member State.  EN 4  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of 17.12.2021  
amending Delegated Regulation (EU) 2016/161 as regards the derogation from the 
obligation of wholesalers to decommission the unique identifier  of medicinal products 
exported to the United Kingdom  
(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 relating to medicinal products for human use1, and 
in particular Article 54a(2) , point (d), thereof,  
Whereas:  
(1) Pursuant to Article 22 (a) of Commission Delegated Regulation (EU) 2016/1612, a 
wholesaler is to decommission the unique identifier of medicinal products which  he 
intends to distribute outside  of the Union . 
(2) On 1 February 2020, the United Kingdom withdrew from the European Union and 
from the European Atomic Energy Community. Pursuant to Articles  126 and 127 of 
the Agreement on the withdrawal of the United Kingdom of Great Britain and 
Northern Ireland from the European Union and the European Atomic Energy 
Community ( the ‘Withdrawal Agreement ’), Union law was applicable to and in the 
United Kingdom during a transition period that ended  on 31 December 2020 (‘the 
‘transition period’).  
(3) In accordance with Article 185 of the Withdrawal Agreement and Article 5(4) of the  
Protocol on Ireland / Northern Ireland , Union legislation on medicinal products  
continued to  apply in Northern Ireland after the end of the transition period . 
(4) The withdrawal of the United Kingdom from the  Union would, in the absence of a 
derogation  from the applicable rules , have  had the effect that  unique identifiers  must  
be decommissioned  for medicinal products intended to be distributed in the United 
Kingdom  except Northern Ireland .  
(5) On 13 January 2021, Delegated Regulation (EU) 2016/161 was amended by 
Commission Delegated Regu lation (EU) 2021/4573 to provide a derogation from the 
requirement to decommission unique identifiers of products exported to the United 
Kingdom until 31 December 202 1. This derogation was intended to ensure the supply 
of medicinal products to small market s historically dependent on the United Kingdom , 
                                                 
1 OJ L 311, 28.11.2001, p.67.  
2 OJ L 32, 9.2.2016, p. 1.  
3 OJ L 91, 17.3.2021, p. 1 . EN 5  EN i.e. Northern Ireland, Cyprus, Ireland and Malta . In those small markets historically 
dependent on the United Kingdom , many medicinal products were and continue to be 
purchased from the United Kingdom by wholesalers not holding manufacturing and 
importation authorisations and therefore unable to meet the importation requirements 
laid down in Directive 2001/83/EC and Delegated Regulation  (EU) 2016/161 . 
(6) In order to en sure that medicinal products continue to be  marketed with  a unique 
identifier in Northern Ireland, Cyprus, Ireland and Malta , it is necessary  to further 
extend the  temporary derogation  from the requirement to decommission unique 
identifiers of products exp orted to the United Kingdom . An additional three -year 
period is needed  to allow industry  sufficient  time to adapt the supply chains of 
medicines destined for Northern Ireland, Cyprus, Ireland and Malta. The derogation 
should, however, be limited to medicinal products solely intended for the United 
Kingdom market or for the United Kingdom market jointly with Cyprus, Ireland or 
Malta . It should not apply to medicinal products  intended for markets other than  the 
United Kingdom  or packaged in EU -wide or global labelling . This derogation should 
not affect the application of Union law to and in the United Kingdom in respect of 
Northern Ireland in accordance with Article 5(4) of the Protocol on Ireland/Northern 
Ireland to the Withdrawal Agreement in conjunction with Annex 2 to that Protocol.   
(7) In order to accommodate the specific characteristics of national supply chains, Article 
23 of  Delegated Regulation (EU) 2016/161 allows Member States to require 
wholesale rs to verify and decommission unique identifiers on behalf of  a list of 
persons or institutions  referred to in that Article . In many cases, this would mean that 
wholesalers  established in parts of the United Kingdom other than Northern Ireland 
should verify and decommission the unique identifiers of medicines supplied to those 
persons or institutions in Northern Ireland. Since those wholesalers are not connected 
to the Union repository system, it is necessary to grant an exceptional derogation f rom 
the requirement to decommissi on the unique identifiers of a medicinal product  in order  
to allow these wholesalers  time to move the verification and decommissioning 
operations to Northern Ireland.   
(8) The purpose of Delegated Regulation (EU) 2016/161 i s to set out the specifications of 
the unique identifier, the safety features and the repositories system with a view to 
establish ing a reliable authentication system  for medicinal products  in the Union . This  
mutual  trust is undermined if repositories outside the Union  can upload  and access  
sensitive content in the system , in particular in light of the  limited means to supervise 
such repositories . 
(9) In order to ensure that medicinal products re -imported into the Union are not placed on 
the market else where than Northern Ireland, Cyprus, Ireland and Malta,  it is necessary 
to ensure that the repositories system provide an alert when the medicinal product  is 
verified elsewhere in the Union . Wholesale rs in Northern Ireland , Cyprus, Ireland and  
Malta should  also perform checks of shipments of medicinal products intended for the 
United Kingdom market received from manufacturers, marketing authorisation holders 
and wholesalers designated by the marketing authorisation holder to ensure the 
products they receive  comply with the rules on safety features.  
(10) Delegated Regulation (EU) 2016/161 should therefore be amended accordingly.  
(11) Having regard to the imminent end of the current derogation , this Regulation should 
enter into force as a matter of urgency . As  the current derogation  ends on 31 
December 2021, this Regulation  should apply from  1 January 202 2, EN 6  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Delegated Regulation (EU) 2016/161 is amended as follows:  
(1) in Article 3(2) , point (d) is replaced by the following:  
‘(d) ‘active unique identifier’ means a unique identifier which has not been 
decommissioned  or which is no longer decommissioned , and which has not 
been identified as a “non -Union pack”  as referred to in Article 36, point (p);’ 
(2) Article 20  is replaced by the following : 
‘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:  
(a) medicinal products returned to him by persons 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 holding t he marketing authorisation nor a 
wholesaler who is designated by the marketing authorisation holder, by means 
of a written contract, to store and distribute the products covered by his 
marketing authorisation on his behalf.  
A wholesaler established in Nort hern Ireland , Cyprus, Ireland or Malta shall perform 
adequate verifications  to ensure that shipments of medicinal products manufactured 
and labelled for the United Kingdom market comply with the requirement to bear 
safety features under Article 54a(1) of D irective 2001/83/EC when received from the 
manufacturer, the marketing authorisation holder  or a wholesaler who is designated 
by the marketing authorisation holder, by means of a written contract, to store and 
distribute the products covered by his marketing authorisation on his behalf. ’ 
(3) in Article 22 , the final paragraph is replaced by the following : 
‘By way of derogation from point (a), until 31 December 2024 , the obligation to 
decommission the unique identifier of  medicinal products which the wholesaler 
intends to distribute outside of the Union shall not apply to medicinal products 
manufactured and labelled for the  United Kingdom  market  or for the United 
Kingdom market and the markets of Cyprus, Ireland or Malta , which he intends to 
distribute in the  United Kingdom . ’ 
(4) in Article 2 6, the following  paragraph 4 is added:  
‘4. Until 31 December 2024 , the authorities of the United Kingdom in respect of 
Northern Ireland may waive the obligation to verify the safety features and 
decommission the unique identifier of a medicinal product supplied to the 
persons or institutions listed  in Article 23 for products for the market of the 
United Kingdom in respect of Northern Ireland supplied from wholesalers 
located in other parts of the United Kingdom. ’ 
(5) in Article 32 (1), point (b), a final sentence  is added : EN 7  EN ‘Repositories which serve territories outside  of the Union shall not be connected to 
the hub. ’ 
(6) in Article 36, the following point (p) is added:  
‘(p) the triggering of an alert identified  as a “non -Union pack” in the repositories 
system and in the terminal where the verification  of the authenticity of a unique 
identifie r in accordance with Article 11  takes place when both of the following 
conditions are met:  
(i) the verification finds that the medicinal product bearing the unique 
identifier is manufactured and labelled for the Un ited Kingdom market or 
for the United Kingdom market and the markets of Cyprus, Ireland or 
Malta;  
(ii) the verification does not take place in Northern Ire land, Cyprus,  Ireland 
or Malta. ’ 
Article 2  
This Regulation shall enter into force on the day following  that of  its publication in the 
Official Journal of the European Union . 
It shall apply from 1 January 202 2. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 17.12.2021  
 For the Commis sion 
 The President  
 Ursula VON DER LEYEN