Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland
Date: 2023-02-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Northern Ireland, United Kingdom, consumer information, drug surveillance, labelling, market approval, medicinal product, product quality, public health, withdrawal from the EU

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   EUROPEAN COMMISSION  Brussels, 27.2.2023  COM(2023) 122 final 2023/0064 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland (Text with EEA relevance)  
 
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL  

Reasons for and objectives of the proposal  

In  accordance  with  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)1, and in  particular Article 
5(4) of the Protocol on Ireland/Northern Ireland (“the Protocol”) in conjunction with 
Annex 2 to that Protocol, Regulation (EC) No 726/20042 and Directive 2001/83/EC3 
as well as the Commission acts based on them, apply to and in the United Kingdom 
(UK) in respect of Northern Ireland.  

Medicines placed on the market in Northern Ireland must therefore be covered by a 
valid marketing authorisation issued by the Commission (EU-wide authorisation) or 
by  the  UK  in  respect  of  Northern  Ireland  in  accordance  with  the  abovementioned 
acts.  

Despite  the  transition  period  provided  for  in  the  Withdrawal  Agreement,  it  proved  
difficult for certain economic operators based in parts of the UK other than Northern 
Ireland  to  adapt  and  move  relevant  regulatory  compliance  functions  (namely,  the 
marketing authorisation holder, quality control (batch) testing, the qualified persons 
responsible  for  batch  testing  and  release  and  for  pharmacovigilance)  to  Northern 
Ireland or the Union in respect of nationally authorised medicines, as required by the 
Protocol.  

To  ensure  the  uninterrupted  supply  of  medicines  covered  by  UK  national 
authorisations from Great Britain to Northern Ireland, as well as to other markets that 
have been historically dependent on supplies from the UK market, the Union adopted 
Directive  (EU)  2022/6424,  which  introduced  derogations  from  certain  obligations 
concerning  certain  medicinal  products  for  human  use  made  available  in  the  UK  in 
respect  of  Northern  Ireland  (and  in  Cyprus,  Ireland  and  Malta).  These  derogations 
allowed economic operators to maintain batch testing and release and manufacturing 
/ regulatory functions in parts of the UK other than Northern Ireland.  

Directive (EU) 2022/642 also introduced a bridging solution on novel medicines that 
under  Union  law  are  authorised  through  the  centralised  procedure  provided  by 
Regulation (EC) No 726/2004. That solution allows the competent authorities of the 
UK  to  authorise  the  supply  to  patients  in  Northern  Ireland  of  a  novel  medicine  for 
which  a  marketing  authorisation  has  been  issued  by  the  competent  authority  of  the 
UK, while there is no marketing authorisation granted yet for the same medicine in 

1  OJ L 29, 31.1.2020, p. 7. 

2  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 (Text with EEA relevance) OJ L 136, 30.4.2004. 

3  Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 

Community code relating to medicinal products for human use OJ L 311, 28.11.2001. 

4  Directive  (EU)  2022/642  of  the  European  Parliament  and  of  the  Council  of  12  April  2022  amending 
Directives  2001/20/EC  and  2001/83/EC  as  regards  derogations  from  certain  obligations  concerning  certain 
medicinal products for human use made available in the United Kingdom in respect of Northern Ireland and 
in Cyprus, Ireland and Malta (Text with EEA relevance) OJ L 118, 20.4.2022. 

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the  Union.  This  possibility  was  granted  on  a  temporary  basis,  until  a  marketing 
authorisation  is  granted  or  refused  in  the  Union,  and  in  any  case  for  a  maximum 
period of six months.  

The practical application of the above provisions on novel medicines has shown that 
any  divergence  between  the  terms  of  the  marketing  authorisations  granted  for  the 
same medicine in the Union and in the UK would require manufacturers to provide 
separate packs and patient leaflets for Great Britain and Northern Ireland. This would 
represent a significant economic burden for the manufacturers concerned relative to 
the small size of the Northern Ireland market and could put at risk the uninterrupted 
supply  of  novel  medicines  to  patients  in  Northern  Ireland.  Both  the  UK  authorities 
and  stakeholders  have  also  raised  concerns  that  the  coexistence  of  potentially 
divergent  marketing  authorisations  for  Great  Britain  and  Northern  Ireland  for  the 
same medicine would create legal uncertainty as to the applicable rules for medicines 
that  need  to  be  made  available  at  all  times  across  the  UK  to  the  same  cohorts  of 
patients.  

Additionally,  medicines  subject  to  prescription  intended  for  the  Northern  Ireland 
market  must  carry  safety  features  in  accordance  with  Union  law.  To  prevent  the 
reintroduction  of  exported  medicines  into  the  EU  single  market,  Article  22(a)  of 
Commission  Delegated  Regulation  (EU)  2016/1615  obliges  wholesalers 
to 
decommission  the  unique  identifier  on  all  medicines  they  export  outside  the  Union 
before they are exported. If the exported medicines are subsequently reimported into 
the Union, the requirements for importation under Directive 2001/83/EC must be met 
and  a  new  unique  identifier  affixed  and  uploaded  to  the  repositories  system.  These 
operations can only be performed by the holder of a manufacturing and importation 
authorisation.  In  December  2021,  the  Commission  Delegated  Regulation  (EU) 
2022/3156 amended Delegated Regulation (EU) 2016/161 with a view to introducing 
a  derogation  from  the  obligation  of  wholesalers  to  decommission  the  unique 
identifier of medicinal products exported to the UK for a period of three years. This 
was  to  prevent  supply  disruptions  in  Northern  Ireland  as  many  medicines  were 
purchased from the UK 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. 

Despite the above-mentioned derogations, the UK and certain stakeholders based in 
the UK have raised concerns that the need for separate marketing authorisations for 
Great Britain and Northern Ireland in respect of novel medicines and the application 
of  the  Union  unique  identifier  requirement  for  medicines  subject  to  prescription 
impose unnecessary administrative burdens for medicines that are to be placed only 
on the Northern Ireland market and will not be made available in any Member State.  

The Commission and the Government of the UK have thus reached a comprehensive set 
of  joint  solutions  to  address  these  concerns,  while  protecting  the  integrity  of  both  the 
Union’s and the UK’s internal markets. 

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

6  Commission  Delegated  Regulation  (EU)  2022/315  of  17  December  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)  OJ  L  55, 
28.2.2022. 

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These joint solutions mark a new way forward to implement the Protocol to ensure legal 
clarity,  predictability  and  prosperity  for  the  people  and  businesses  in  Northern  Ireland 
while at the same time preventing any risks to public health in the internal market.  

This Proposal reflects these joint solutions, to provide that:  

– 

– 

New  and  innovative  medicines  lawfully  placed  on  the  market  in  Northern 
Ireland are to be only covered by a valid marketing authorisation issued by the 
UK  according  to  the  law  of  the  UK.  The  placing  on  the  market  of  these 
medicines will therefore not anymore be  regulated by EU-wide authorisations 
granted by the Commission. 

The  EU  safety  features  that  must  be  displayed  on  packs  of  medicines  subject  to 
prescription in the Union should not appear on packs of medicines made available 
to patients in Northern Ireland.  

These  solutions  are  accompanied  by  safeguards  to  ensure  that  all  medicines  placed  on 
the market in Northern Ireland will not be made available in any Member State. These 
include labelling UK packs with a specific label: “UK only”, continuous monitoring by 
the  UK  competent  authorities  as  well  as  the  possibility  for  the  Commission  to 
unilaterally suspend the application of the new rules in case of UK non-compliance with 
its obligations. 

Consistency with existing policy provisions in the policy area  

A  comprehensive  Union  medicinal  products  legislative  framework  is  established, 
including Regulation (EC) 726/2004 and Directive 2001/83/EC, which are of relevance 
for this initiative that will complement and amend them.  

Consistency with other Union policies  

This  proposal  does  not  affect  other  Union  policies,  except  for  the  health  and  internal 
market rules. Therefore, the assessment of the consistency with other Union policies is 
not considered necessary.  

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY  

Legal basis  

Article  114  of  the  Treaty  on  the  Functioning  of  the  European  Union,  which  is  the 
same legal basis for the existing Union legislation in the area of medicinal products.  

Subsidiarity (for non-exclusive competence)  

This  Proposal  provides for specific rules for the  placing  on the market  in Northern 
Ireland of medicinal products for human use.  

Proportionality  

This  Proposal  lays  down  a  comprehensive  framework  of  conditions,  specific  rules 
and safeguards. It lays down specific rules for the placing on the market in Northern 
Ireland  of  medicines  for  human  use.  It  empowers  the  Commission  to  adopt  the 
necessary delegated acts for the suspension of specific rules if there is evidence that 
the  UK  does  not  take  appropriate  measures  to  tackle  serious  or  repeated 
infringements of the specific rules. The act also provides for a number of safeguard 
mechanisms to ensure that the integrity of the Union’s internal market is protected. 

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2. 

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• 

Choice of the instrument  

As the initiative concerns the adoption of specific rules in an area to which several 
Union  acts  apply,  a  proposal  for  a  Regulation  of  the  European  Parliament  and 
Council is considered to be the appropriate instrument. 

3. 

RESULTS  OF  EX-POST  EVALUATIONS,  STAKEHOLDER  CONSULTATIONS 
AND IMPACT ASSESSMENTS  

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Ex-post evaluations/fitness checks of existing legislation  

Not applicable  

Stakeholder consultations  

This initiative is proposed following bilateral discussions with the  UK and industry 
associations  and  other  relevant  stakeholders.  No  open  public  consultation  will  be 
carried out. 

Collection and use of expertise 

Not applicable 

Impact assessment 

The  proposal  is  exempted  from  the  impact  assessment  due  to  the  urgency  of  the 
situation. 

Regulatory fitness and simplification 

Not applicable 

Fundamental rights 

The  proposed  Regulation  contributes  to  achieving  a  high  level  of  human  health 
protection  as  set  out  in  Article  35  of  the  Charter  of  Fundamental  Rights  of  the 
European Union. 

4. 

BUDGETARY IMPLICATIONS 

There are no implications for the Union budget. 

5. 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

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• 

Not applicable 

Explanatory documents (for directives) 

Not applicable 

Detailed explanation of the specific provisions of the proposal 

Not applicable 

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2023/0064 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on specific rules relating to medicinal products for human use intended to be placed on 
the market of Northern Ireland 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

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

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee1, 
Having regard to the opinion of the Committee of the Regions2,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

1 

2 

3 

4 

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)  was  concluded  on  behalf  of  the  Union  by 
Council  Decision  (EU)  2020/1353  and  entered  into  force  on  1  February  2020.  The 
transition period referred to in Article 126 of the Withdrawal Agreement, during which 
Union  law  continued  to  apply  to  and  in  the  United  Kingdom,  in  accordance  with 
Article 127 of the Withdrawal Agreement, ended on 31 December 2020.  

The Protocol on Ireland/Northern Ireland (the Protocol) forms an integral part of the 
Withdrawal Agreement. 

The  provisions  of  Union  law  listed  in  Annex  2  to  the  Protocol  apply,  under  the 
conditions set out in that Annex, to and in the United Kingdom in respect of Northern 
Ireland.  That  list  includes,  but  it  is  not  limited  to,  Directive  2001/83/EC  of  the 
European  Parliament  and  of  the  Council4  and  Regulation  (EC)  No  726/2004  of  the 

OJ C , , p. . 

OJ C , , p. . 

Council  Decision  (EU)  2020/135  of  30  January  2020  on  the  conclusion  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  (OJ L 29, 31.1.2020, p. 1). 

Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

European Parliament and of the Council5. Therefore, medicinal products placed on the 
market in Northern Ireland are required to comply with those provisions of Union law.  

Directive 2001/83/EC lays down the rules for medicinal products for human use and 
Regulation  (EC)  No  726/2004  lays  down  Union  procedures  for  the  authorisation  of 
medicinal products for human use.  

In order to take account of the specific situation of Northern Ireland, it is appropriate 
to  adopt  specific  rules  relating  to  the  placing  on  the  market  of  Northern  Ireland  of 
medicinal products for human use. 

It is appropriate to clarify that the provisions listed in Annex 2 to the Protocol apply in 
respect  of  medicinal  products  for  human  use  intended  to  be  placed  on  the  market  in 
Northern  Ireland  unless  specific  provisions  are  laid  down  by  this  Regulation.  Where 
the specific provisions of this Regulation apply, and in the event of any inconsistencies 
between those specific provisions and the provisions listed in Annex 2 to the Protocol, 
those specific provisions should take precedence. 

Furthermore, it is important to lay down rules which ensure that the application of the 
specific rules laid down in this Regulation does not lead to an increased risk to public 
health in the internal market.  

The specific rules should include the prohibition to display the safety features referred 
to  in  Directive  2001/83/EC  on  the  outer  packaging  or,  where  there  is  no  outer 
packaging, on the immediate packaging of medicinal products for human use intended 
to  be  placed  on  the  market  in  Northern  Ireland  and  the  prohibition  to  place  on  the 
market  in  Northern  Ireland  new  and  innovative  medicinal  products  that  have  been 
granted a marketing authorisation in  accordance with  Regulation  (EC) No 726/2004. 
Furthermore,  the  specific  rules  should  include  certain  labelling  requirements  for 
medicinal  products  for  human  use  intended  to  be  placed  on  the  market  in  Northern 
Ireland. As a consequence, Commission Delegated Regulation (EU) 2016/1616 should 
not apply to medicinal products for human use intended to be placed on the market in 
Northern Ireland. 

In  respect  of  new  and  innovative  products,  the  competent  authorities  of  the  United 
Kingdom  should  authorise  the  placing  of  these  products  on  the  market  in  Northern 
Ireland  once certain conditions are fulfilled, including that the authorisation is granted 
in accordance with the law of the United Kingdom and that the products are placed on 
the  market  in  Northern  Ireland  under  the  terms  of  the  authorisation  granted  by  the 
competent authorities of the United Kingdom, that these products comply with certain 
labelling  requirements,  and  lastly  that  the  written  guarantees  have  been  provided  by 
the United Kingdom to the European Commission.  

(10)  At the same time, appropriate safeguards for the Union should be put in place in order 
to  ensure  that  the  application  of  the  specific  rules  does  not  increase  risks  to  public 
health  in  the  internal  market.  Such  safeguards  should  include  continuous  monitoring 

5 

6 

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). 

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

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from the competent authority of the United Kingdom on the placing on the market in 
Northern  Ireland  of  medicinal  products  for  human  use  subject  to  specific  rules  laid 
down in this Regulation and a total prohibition on the movement to or placing on the 
market in a Member State of medicinal products subject to the specific rules laid down 
in this Regulation.  

(11)  Furthermore, it is appropriate to empower the Commission to adopt delegated acts to 
suspend  the  application  of  some  or  all  of  the  specific  rules  laid  down  in  this 
Regulation where there is evidence that the United Kingdom does not take appropriate 
measures to tackle serious or repeated infringements of these specific rules. In such an 
event,  it  is  appropriate  to  provide  for  a  formal  information  and  consultation 
mechanism with clear time periods within which the Commission should act. 

(12) 

(13) 

(14) 

In  the  case  of  the  suspension  of  the  specific  rules  for  the  placing  on  the  market  in 
Northern Ireland of the medicinal products, the relevant provisions listed in Annex 2 
to the Protocol should apply again to such medicinal products. 

In  order  to  ensure  an  effective  and  swift  reaction  to  any  increased  risk  for  public 
health, this Regulation should provide for the possibility for the Commission to adopt 
delegated acts in accordance with an urgency procedure.  

It is appropriate to provide for a transitional period for the application of specific rules 
laid down in this Regulation to medicinal products for human use which are already on 
the market in Northern Ireland. 

(15)  As  a  consequence  of  the  entry  into  force  of  this  Regulation,  Directive  2001/83/EC 

should be amended accordingly, 

HAVE ADOPTED THIS REGULATION 

Article 1 
Subject matter and scope 

1. 

2. 

3. 

This  Regulation  lays  down  specific  rules  relating  to  medicinal  products  for  human 
use  intended  to  be  placed  on  the  market  in  Northern  Ireland  in  accordance  with 
Article 6 of Directive 2001/83/EC.  

This Regulation also lays down rules regarding the suspension of the application of 
the specific rules laid down in this Regulation.  

The  provisions  listed  in  Annex  2  to  the  Protocol  on  Ireland/Northern  Ireland  (the 
Protocol) shall apply in  respect of the placing on the market in Northern Ireland of 
the  medicinal  products  referred  to  in  paragraph  1  of  this  Article,  unless  specific 
provisions are laid down in this Regulation. 

Article 2 
Definitions 

For the purposes of this Regulation, the definitions laid down in Article 2 of Regulation No 
726/2004  shall  apply,  including  the  definitions  laid  down  in  Article  1  of  Directive 
2001/83/EC.  

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1. 

2. 

3. 

4. 

Article 3 
Specific rules for medicinal products referred to in Article 1(1)  

The competent authorities of the United Kingdom in respect of Northern Ireland may 
allow medicinal products referred to in Article 1(1) of this Regulation to be imported 
into  Northern  Ireland  from  other  parts  of  the  United  Kingdom  by  holders  of  a 
wholesale  distribution  authorisation  that  are  not  in  possession  of  a  relevant 
manufacturing authorisation provided that the conditions laid down in Article 40(1a) 
points (a) to (d) of Directive 2001/83/EC are fulfilled.  

The safety features referred to in Article 54, point (o), of Directive 2001/83/EC shall 
not  appear  on  the  outer  packaging  or,  where  there  is  no  outer  packaging,  on  the 
immediate  packaging  of  medicinal  products  referred  to  in  Article  1(1)  of  this 
Regulation.  

Where  a  medicinal  product  referred  to  in  Article  1(1)  of  this  Regulation  bears  the 
safety feature referred to in Article 54, point (o), of Directive 2001/83/EC, it shall be 
fully removed or covered.  

The qualified person referred to in Article 48 of Directive 2001/83/EC shall, in the 
case of medicinal products referred to in Article 1(1) of this Regulation, ensure that 
the safety features referred to in Article 54, point (o), of Directive 2001/83/EC have 
not been affixed on the packaging of the medicinal product. 

5. 

Holders of a wholesale distribution authorisation shall not be required to:  

(a) 

verify  the  medicinal  products  referred  to  in  Article  1(1)  of  this  Regulation  in 
accordance with Article 80, point (ca), of Directive 2001/83/EC; 

(b)  keep records in accordance with Article 80, point (e), of Directive 2001/83/EC. 

6. 

For all supplies of medicinal products referred to in Article 1(1) of this Regulation to 
a person authorised or entitled to supply medicinal products to the public, as referred 
to in Article 82 of Directive 2001/83/EC, as regards the United Kingdom in respect 
of  Northern  Ireland,  the  authorised  wholesaler  shall  not  be  required  to  enclose  a 
document in accordance with the last indent of the first paragraph of that Article.  

Article 4 
Specific rules for medicinal products referred to in Article 1(1) of this Regulation belonging 
to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004  

1. 

2. 

A  medicinal  product  referred  to  in  Article  1(1)  of  this  Regulation  belonging  to  the 
categories  referred  to  in  Article  3(1)  and  (2)  of  Regulation  (EC)  No  726/2004  that 
has  been  granted  a  marketing  authorisation  in  accordance  with  Article  10  of  that 
Regulation, shall not be placed on the market in Northern Ireland.  

A  medicinal  product  referred  to  in  Article  1(1)  of  this  Regulation  belonging  to  the 
categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 may be 
placed on the market in Northern Ireland if all the following conditions are met:  

(a) 

the competent  authorities of the United  Kingdom  have authorised the placing 
on the market of the product in accordance with the law of the United Kingdom 
and under the terms of the authorisation granted by the competent authorities of 
the United Kingdom;  

(b) 

the medicinal product concerned is labelled in accordance with Article 5;  

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(c)  written  guarantees  are  provided  by  the  United  Kingdom  to  the  European 

Commission in accordance with Article 8.  

Article 5 
Specific rules for labelling requirements for medicinal products referred to in Article 1(1)   

Medicinal  products  referred  to  in  Article  1(1)  shall  bear  an  individual  label  which  shall 
comply with the following conditions:  

(a) 

it shall be attached to the packaging of the medicinal product in a conspicuous place 
in such a way as to be easily visible, clearly legible, and indelible; it shall not be in 
any way be hidden, obscured, detracted from, or interrupted by any other written or 
pictorial matter or any other intervening material. 

(b) 

it shall state the following words: ‘UK only’ 

Article 6 
Monitoring of medicinal products referred to in Article 1(1)  

The competent authority of the United Kingdom shall continuously monitor the  placing into 
the  market  in  Northern  Ireland  of  medicinal  products  referred  to  in  Article  1(1)  and  the 
effective enforcement of the specific rules laid down in Articles 3, 4 and 5. 

Article 7 
Prohibition on the movement to or placing on the market in a Member State of medicinal 
products referred to in Article 1(1) 

1. 

2. 

Medicinal  products  referred  to  in  Article  1(1)  shall  not  be  moved  from  Northern 
Ireland to a Member State or be placed on the market in a Member State.  

The  Member  States  shall  apply  effective  dissuasive  and  proportionate  sanctions  in 
the case of non-compliance with the rules laid down in this Regulation.  

Article 8 
Written guarantees by the United Kingdom to the European Commission 

The United Kingdom shall provide the European Commission with written guarantees that the 
placing on the market of the medicinal products referred to in Article 1(1) does not increase 
the risk to public health in the internal market and that those medicinal products will not be 
moved to a Member State, including guarantees to the effect that: 

(a) 

(b) 

1. 

2. 

economic operators comply with the labelling requirements laid down in Article 5;  

effective  monitoring,  enforcement  and  controls  of  the  specific  rules  laid  down  in 
Articles  3,  4  and  5  are  in  place  and  are  carried  out,  by  means  of,  inter  alia, 
inspections and audits. 

Article 9 
Suspension of the special rules laid down in Articles 3, 4 and 5  

The Commission shall continuously monitor the application by the United Kingdom 
of the specific rules laid down in in Articles 3, 4 and 5. 

Where there is evidence that the United Kingdom does not take appropriate measures 
to  address  serious  or  repeated  infringements  of  the  specific  rules  laid  down  in 

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Articles 3, 4 and 5, the Commission shall inform the United Kingdom by means of 
written notification. 

For  a  period  of  three  months  from  the  date  of  that  written  notification,  the 
Commission shall enter into consultations with the United Kingdom with a view to 
remedying the situation giving rise to that written notification. In justified cases, the 
Commission may extend that period by three months. 

If the situation giving rise to the written notification referred to in paragraph 2, first 
subparagraph,  is  not  remedied  within  the  time-limit  referred  to  in  paragraph  2, 
second subparagraph, the Commission shall be empowered to adopt a delegated act, 
in accordance with Articles 10 and 11 of this Regulation, specifying the provisions 
among  those  referred  to  in  paragraph  1  whose  application  shall  be  temporary  or 
permanently suspended. 

Where  a  delegated  act  has  been  adopted  in  accordance  with  paragraph  3  of  this 
Article, the provisions referred to in Articles 3, 4 or 5 as specified in the delegated 
act shall cease to apply on the first day of the month following the entry into force of 
the delegated act. 

Where  the  situation  giving  rise  to  the  adoption  of  the  delegated  act  in  accordance 
with  paragraph  3  of  this  Article  has  been  remedied,  the  Commission  shall  adopt  a 
delegated  act  specifying  those  suspended  provisions  of  Articles  3,  4  or  5  that  shall 
apply again.  

In  that  case,  the  provisions  specified  in  the  delegated  act  adopted  pursuant  to  this 
paragraph  shall  apply  again  on  the  first  day  of  the  month  following  the  entry  into 
force of the delegated act referred to in this paragraph. 

Article 10 
Exercise of the delegation 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

The power to adopt delegated acts referred to in Article 9 shall be conferred on the 
Commission  for  a  period  of  five  years  from  the  date  of  application  referred  to  in 
Article 14 of this Regulation. The delegation of power shall be tacitly extended for 
periods  of  an  identical  duration  unless  the  European  Parliament  or  the  Council 
opposes such extension not later than three months before the end of each period.  

The delegation of power referred to in Article 9 may be revoked at any time by the 
European Parliament or by the Council. A decision to revoke shall put an end to the 
delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day 
following  the  publication  of  the  decision  in  the  Official  Journal  of  the  European 
Union  or  at  a  later  date  specified  therein.  It  shall  not  affect  the  validity  of  any 
delegated acts already in force.  

Before adopting a delegated act, the Commission shall consult experts designated by 
the 
in  accordance  with 
each  Member  State 
Interinstitutional Agreement of 13 April 2016 on Better Law-Making.  

the  principles 

laid  down 

in 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

3. 

4. 

5. 

6. 

7. 

1. 

2. 

3. 

4. 

5. 

EN 

10 

  EN 

 
6. 

1. 

2. 

A  delegated  act  adopted  pursuant  to  Article  9  shall  enter  into  force  only  if  no 
objection  has  been  expressed  either  by  the  European  Parliament  or  the  Council 
within a period of two months of notification of that act to the European Parliament 
and  to  the  Council  or  if,  before  the  expiry  of  that  period,  the  European  Parliament 
and the Council have both informed the Commission that they will not object. That 
period shall be extended by two months at the initiative of the European Parliament 
or of the Council. 

Article 11 
Urgency procedure 

Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and 
shall apply as long as no objection is expressed in accordance with paragraph 2. The 
notification  of  a  delegated  act  to  the  European  Parliament  and  to  the  Council  shall 
state the reasons for the use of the urgency procedure.  

Either  the  European  Parliament  or  the  Council  may  object  to  a  delegated  act  in 
accordance  with  the  procedure  referred  to  in  Article  10(6).  In  such  a  case,  the 
Commission  shall  repeal  the  act  immediately  following  the  notification  of  the 
decision to object by the European Parliament or by the Council. 

Article 12 
Transitional provisions for safeguards requirements 

Medicinal products that have been lawfully placed on the market in Northern Ireland before 
the date of application referred to in Article 14 of this Regulation, and that are not repackaged 
or relabelled after that date, may be further made available on the market in Northern Ireland 
until their expiry date without being required to comply with the specific rules  laid down in 
Articles 3, 4 or 5. 

Article 13 
Amendment to Directive 2001/83/EC 

Article  5a  of  Directive  2001/83/EC  is  deleted  from  the  date  of  application  referred  to  in 
Article 14 of this Regulation.  

Article 14 
Entry into force and application 

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  2025,  provided  that  the  United  Kingdom  has  provided  the 
written guarantees referred to in Article 8.  

In the case that those written guarantees are provided earlier than 1 January 2025 or later than 
that  date,  this  Regulation  shall  apply  from  the  first  day  of  the  month  following  the  month 
during which the United Kingdom provides these written guarantees.   

The Commission shall publish a Notice in the Official Journal indicating the date from which 
this Regulation applies.  

EN 

11 

  EN 

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

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

12 

  EN