REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the assessment of written guarantees provided by the United Kingdom to the Commission pursuing Article 8 of Regulation (EU) 2023/1182 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 in Northern Ireland
Date: 2024-11-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Northern Ireland, United Kingdom, consumer information, drugs classification, labelling, market approval, medicinal product, product quality, public health, withdrawal from the EU

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 29.11.2024  COM(2024) 565 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the assessment of written guarantees provided by the United Kingdom to the Commission pursuing Article 8 of Regulation (EU) 2023/1182 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 in Northern Ireland  
 
 
CONTENTS 
EXECUTIVE SUMMARY ........................................................................................................................ 2 

1. 

INTRODUCTION AND LEGAL FRAMEWORK ............................................................................... 4 

2.  ASSESSMENT OF THE WRITTEN GUARANTEES .......................................................................... 4 

2.1.  Guarantees as regards Article 5 of Regulation (EU) 2023/1182 ........................................ 5 

2.2.  Guarantees as regards Article 3 of Regulation (EU) 2023/1182 ........................................ 7 

2.3.  Guarantees as regards Article 4 of Regulation (EU) 2023/1182 ...................................... 10 

3.  CONCLUSION ............................................................................................................................ 11 

1 

 
 
 
EXECUTIVE SUMMARY 

Regulation (EU) 2023/1182 (1) applies to and in the United Kingdom in respect of Northern 
Ireland under the Windsor Framework (2) pursuant to Withdrawal Agreement Joint Committee 
Decision  2/2023 (3).  Regulation  (EU)  2023/1182 provides  for  specific  rules  for  medicinal 
products  for  human  use  intended  to  be  placed  on  the  market  in  Northern  Ireland.  It 
implements the joint solutions reached in February 2023 between the European Commission 
and the Government of the United Kingdom to ensure the continuous supply of medicines to 
patients in Northern Ireland in the same way and at the same time as in the rest of the United 
Kingdom.   

According  to  these  rules,  novel  medicines  (4)  for  the  Northern  Ireland  market  will  be 
authorised  in  accordance  with  UK  rules  and  UK  authorisation  procedures  only.  In  addition, 
prescription  medicines  placed  on  the  Northern  Ireland  market  should  not  carry  the  safety 
features (5) (unique identifier/barcode) that are obligatory in the Union to prevent circulation 
of falsified medicines within the internal market so that they are easily distinguishable from 
those placed on the Union market. 

Pursuant  to  Regulation  (EU)  2023/1182,  the  United  Kingdom  must  put  in place appropriate 
safeguards to  ensure that UK-authorised medicines do not  end up on the market  of  any EU 
Member State. This includes the requirement that individual packs of all medicines placed on 
the Northern Ireland market bear a label indicating “UK only”. 

In  this  respect,  pursuant  to  Article  8  of  Regulation  (EU)  2023/1182,  the  United  Kingdom 
provided the Commission on 20 November 2024 with written guarantees that the placing on 
the market in Northern Ireland of medicinal products for human use as referred to in Article 
1(1) of Regulation (EU) 2023/1182 does not increase the risk to public health in the internal 

(1)  Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules 
relating to medicinal products for human use intended to be placed on the market in Northern Ireland and 
amending Directive 2001/83/EC (OJ L 157, 20.6.2023, p. 1). 

(2)  The Windsor Framework is the new way in which the Protocol on Ireland/Northern Ireland is referred to in 
accordance with Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee 
established  by  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  of  24 March  2023 
(OJ L 102, 17.4.2023, p. 87). 

(3)  Decision No 2/2023 of the Joint Committee established by 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 of 3 July 2023 adding two newly adopted Union acts to Annex 2 to the Windsor Framework 
(OJ L 184, 21.7.2023, p. 109). 

(4)   “Novel medicines” in this context should be understood as medicines belonging to the categories referred to 
in Article 3(1) and (2) of 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). 

(5)   “Safety features” as referred to in Article 54, point (o) of 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). 

2 

 
 
 
 
market  and  that  such  medicinal  products  will  not  be  moved  to  a  Member  State.  They  also 
include  guarantees  to  that  effect  that  economic  operators  comply  with  the  specific  labelling 
requirements  provided  for  in  Article  5  of  Regulation  (EU)  2023/1182  and  that  effective 
monitoring,  enforcement and controls  of the new specific rules set in Articles 3, 4 and 5 of 
Regulation  (EU)  2023/1182  are  in  place  and  are  carried  out,  by  means  of,  inter  alia, 
inspections and audits. 

Pursuant  to  the  second  subparagraph  of  Article  14  of  Regulation  (EU)  2023/1182,  the 
Regulation  is  to  apply  from  1  January  2025  (6),  provided  that  the  United  Kingdom  has 
provided  the  written  guarantees  referred  to  in  Article  8  of  that  Regulation  and  that  the 
Commission has published prior to that date a notice in the Official Journal of the European 
Union indicating the date from which the Regulation applies.  

The Commission carried out its assessment based on the information included in the written 
guarantees  and  also  considering  the  legal  instruments  and  related  guidance  the  United 
Kingdom  has  adopted  and  published  in  relation  to  the  implementation  of  Regulation  (EU) 
2023/1182.  On  this  basis  it  can  be  concluded  that  the  measures  presented  in  the  written 
guarantees, if fully implemented, provide reasonable assurance as to their conformity with the 
requirements of Article 8 of Regulation (EU) 2023/1182. 

6   To be noted that, pursuant to Article 12 of Regulation (EU) 2023/1182, medicinal  products that have been 
lawfully placed on the market in Northern Ireland before the date of application of that 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 and 5 of that Regulation. 

3 

 
 
 
INTRODUCTION AND LEGAL FRAMEWORK 

1. 
Regulation  (EU)  2023/1182  applies  to  and  in  the  United  Kingdom  in  respect  of  Northern 
Ireland under the Windsor Framework and provides that novel  medicines will be authorised 
and  placed  on  the  market  in  Northern  Ireland  in  accordance  with  UK  rules  and  UK 
authorisation procedures only. In order to easily distinguish the prescription medicines placed 
on the Northern Ireland market from those placed on the Union market, medicines placed on 
the  Northern  Ireland  market  should  not  carry  the  safety  features  (unique  identifier/barcode) 
that are obligatory in the Union to prevent entry of falsified medicines into the supply chains. 

The  new  rules  go  hand  in  hand  with appropriate  safeguards to  ensure  that  UK-authorised 
medicines  do  not  end  up  on  the  market  of  any  EU  Member  State.  Individual  packs  of  all 
medicines  placed  on  the  Northern  Ireland  market  should  thus  bear  a  label  indicating  “UK 
only” and the competent authority in the United Kingdom should continuously monitor their 
placing on the Northern Ireland market. The Commission will monitor the application of the 
rules by the United Kingdom and take appropriate measures in case of non-compliance.  

In accordance with Article 8 of Regulation (EU) 2023/1182, the United Kingdom is to provide 
the Commission with written guarantees that the placing on the market of medicinal products 
does  not  increase  the  risk  to  public  health  in  the  internal  market  and  that  such  medicinal 
products will not be moved to a Member State, including guarantees to the effect that: 

(a) 

(b) 

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

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

In accordance with Article 14(4) of Regulation (EU) 2023/1182, the Commission is to provide 
the European Parliament and the Council with its assessment of these guarantees within one 
month from their submission.  

On  20  November  2024,  the  United  Kingdom  provided  to  the  Commission  the  written 
guarantees  referred  to  in Article  8  of  Regulation  (EU)  2023/1182.  This  report  provides  the 
European Parliament and the Council with the Commission’s assessment of these guarantees. 
The Commission carried out its assessment based on the information included in the written 
guarantees  and  also  considering  the  legal  instruments  and  related  guidance  the  United 
Kingdom has adopted in relation to the implementation of Regulation (EU) 2023/1182. 

ASSESSMENT OF THE WRITTEN GUARANTEES 

2. 
The  written  guarantees  submitted  by  the  United  Kingdom  are  structured  in  three  key  parts 
which are being analysed in turn in the following subsections. 

In  the  introduction  to  the  guarantees,  the  United  Kingdom  outlines  the  division  of 
responsibilities  and  working  arrangements  between  the  relevant  governmental  departments 
responsible for the implementation and the enforcement of the rules applicable to medicinal 
products  for  human  use  as  referred  to  in Article  1(1)  of  Regulation  (EU)  2023/1182. These 

4 

 
 
involve the Department of Health and Social Care (“DHSC”), the Medicines and Healthcare 
Products  Regulatory  Agency  (“MHRA”)  and  the  Medicines  Regulatory  Group  (“MRG”), 
which is part of the Department of Health (“DOH”) in the Northern Ireland Executive. 

In  accordance  with  Article  7  of  Regulation  (EU)  2023/1182,  in  its  written  guarantees,  the 
United Kingdom refers to existing safeguards in the UK Human Medicines Regulation 2012 
(7) which ensure that medicinal products for human use intended to be placed on the market in 
Northern Ireland will not be moved or placed on the market in a Member State. In accordance 
with the UK Human Medicines Regulation 2012, UK operators would also need to further act 
in  compliance  with  Good  Manufacturing  Practice,  Good  Distribution  Practice  and  the 
Marketing Authorisation  (Regulations  37,  43  and  46).  For  companies  with  valid  licences  in 
Northern Ireland, the UK Human Medicines Regulation 2012 would require compliance with 
the EU principles and guidelines on Good Distribution Practice for medicinal products as laid 
down  in  Article  84  of  Directive  2001/83/EC.  The  UK  Human  Medicines  Regulation  2012 
would  also  require  wholesalers  to  take  the  appropriate  measures  to  ensure  that  medicinal 
products  authorised  according  to  UK  law  do  not  enter  the  Union  market.  The  Commission 
considers  that  these  safeguards  are  adequate  and  necessary  to  ensure  that  UK  authorised 
medicines will not be moved to the market of any EU Member State as provided for in Article 
7(1) of Regulation (EU) 2023/1182. 

2.1.  Guarantees as regards Article 5 of Regulation (EU) 2023/1182  
This section addresses specifically the measures presented in the written guarantees to ensure 
application of the specific labelling requirements for medicinal products for human use 
intended to be placed on the market in Northern Ireland laid down in paragraphs (a) and (b) of 
Article 5 of the Regulation. 

Article 5 

Specific rules for the labelling of medicinal products as referred to in Article 1(1) 

Medicinal products as referred to in Article 1(1) shall bear an individual label that complies 
with the following requirements: 

(a) 

it shall be attached to the packaging of the medicinal product in a conspicuous place in such a 
way  that  it  is  easily  visible,  clearly  legible,  and  indelible;  it  shall  not  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 words ‘UK only’. 

The Commission acknowledges that the written guarantees confirm that, according to the UK 
Human Medicines Regulation 2012, the inclusion of a “UK only” statement on the labelling 
on  all  medicines  for  human  use  placed  on  the  market  in  Northern  Ireland  is  a  legal 
requirement  applicable  from  1  January  2025.  It  seems  to  be  proportional  that  the  United 

(7)  The  Human  Medicines  (Amendments  relating 

to 

the  Windsor  Framework)  Regulations  2024 

(https://www.legislation.gov.uk/uksi/2024/832/contents/made). 

5 

 
 
 
Kingdom  would  allow  a  limited  transition  period  of  6  months  until  30  June  2025,  during 
which  the  application  of  the  “UK  only”  label  could  take  the  form  of  an  indelible  sticker 
compliant with the requirements set out in Article 5 of Regulation (EU) 2023/1182. After 30 
June 2025, it would be mandatory for the “UK only” statement to be printed directly onto the 
packaging  and  the  use  of  an  indelible  sticker  would  no  longer  be  allowed.  The  written 
guarantees state that compliance with the requirements set out in Article 5 of Regulation (EU) 
2023/1182  will  be  subject  to  effective  monitoring,  enforcement,  and  controls  by  the  United 
Kingdom. 

The written guarantees outline several measures to support compliance with the specific rules 
for  the  labelling  of  medicinal  products  for  human  use.  They  also  provide  information  on 
regulatory oversight processes and on inspections and controls. 

As part of the measures to support compliance, the written guarantees mention that guidance 
relating  to  labelling  and  packaging  requirements  has  been  published  for  the  purpose  of 
supporting industry compliance. (8) 

Moreover,  the  written  guarantees  also  provide  that,  before  implementing  any  changes  to 
labelling  or  packaging,  companies  must  notify  the  MHRA  before  31  December  2024  of  all 
intended artwork changes, the compliance of which with legal requirements will be checked 
by  the  MHRA.  The  written  guarantees  describe  three  regulatory  options  for  companies  to 
notify the MHRA of updates to the labelling or packaging: 

1. 

2. 

3. 

a submission of the intended artwork changes together with and in the framework of 
another application (such as a variation) and implementation of artworks after formal 
approval;  

a  submission  of  a  separate  self-certification  notification,  allowing  the  marketing 
authorisation holder (MAH) to implement the proposed and submitted changes before 
receiving formal approval from the authority, before 1 January 2025;  

a submission of a self-certification notification without initial update of the Electronic 
Common Technical  Document  (eCTD)  by  31  December  2024,  and  submission  of  an 
updated eCTD sequence until 31 December 2025. 

The progress of submission of these labelling changes would be monitored by the MHRA to 
identify cases of non-compliance after 1 January 2025 for further investigation and corrective 
regulatory action as necessary.  

The  Commission  acknowledges  that  the  MHRA’s  GMP  inspections  and  control  programme 
would  be  updated  from  1  January  2025  to  include  the  new  labelling  requirements  set  in 

(8)  Labelling  and  packaging  of  medicinal  products  for  human  use  following  agreement  of  the  Windsor 
(https://www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-

Framework 
for-human-use-following-agreement-of-the-windsor-framework/labelling-and-packaging-of-medicinal-
products-for-human-use-following-agreement-of-the-windsor-framework). 

6 

 
 
 
 
Regulation  (EU)  2023/1182.  Good  Manufacturing  Practice  /  Good  Distribution  Practice 
(GMDP) inspections of pharmaceutical wholesalers, manufacturers and importers in Northern 
Ireland would be carried out by the MHRA. The MRG would inspect also other entities at the 
end  of  the  medicinal  product  supply  chain  such  as  community  and  hospital  pharmacies, 
private hospitals, and UK National Health Service (NHS) hospitals. Inspections would follow 
a  risk-based  approach  and  focus  on  change  management,  which  includes  the  new  specific 
labelling  rules  set  in  Article  5  of  Regulation  (EU)  2023/1182.  The  MHRA  would  further 
follow-up with and monitor economic operators who have not submitted the artwork changes. 
Should  deviations  be identified, the MHRA would inform  the MRG and follow up with  the 
respective economic operator requiring compliance actions, conduct follow-up inspections or 
suspend  the  authorisation  should  there  be  persisting  non-compliance.  The  DOH  would  also 
provide assurances to the MHRA that appropriate monitoring and enforcement controls are in 
place as required by law, to ensure compliance with Article 5 of Regulation (EU) 2023/1182, 
in  areas  that  are  within  DOH’s  responsibility.  With  regard  to  inspectors,  the  MHRA  would 
provide relevant training to inspectors to assess compliance with Regulation (EU) 2023/1182 
by 1 January 2025. 

In view of the  above guarantees provided by the United Kingdom  with respect to the specific 
labelling rules for medicinal products for human use intended to be placed on the market in 
Northern  Ireland  set  out  in  Article  5  of  Regulation  (EU)  2023/1182,    the  Commission 
considers  that  the  measures  taken  by  the  United  Kingdom  address  appropriately  all  the 
relevant  aspects  of  Article  5  given  that  the  required  legal  measures  have  been  taken  ,  
adequate  guidance  to  all  concerned  stakeholders  has  been  published  and  appropriate 
procedures to ensure the update/introduction of the artworks are in place. In this respect, the 
provided guarantees therefore seem to be adequate to ensure that economic operators comply 
with  those  requirements,  in  line  with  the  objectives  set  out  in Article  8  of  Regulation  (EU) 
2023/1182.  Also,  effective  monitoring,  enforcement  and  controls  of  the  specific  rules  laid 
down  in Article  5  are  in  place  and  are  carried  out,  by  means  of,  inter  alia,  inspections  and 
audits. 

2.2.  Guarantees as regards Article 3 of Regulation (EU) 2023/1182 
This section addresses specifically the measures presented in the written guarantees to comply 
with the requirement that effective monitoring, enforcement and controls of the specific rules 
laid  down  in  Article  3  of  Regulation  (EU)  2023/1182  are  in  place  and  are  carried  out,  by 
means  of,  inter  alia,  inspections  and  audits,  including  to  ensure  that  the  safety  features 
referred  to  in  Article  54,  point  (o),  of  Directive  2001/83/EC  do  not  appear  on  the  outer 
packaging  or,  where  there  is  no  outer  packaging,  on  the  immediate  packaging  of  medicinal 
products  placed on the  market  in  Northern  Ireland, as  referred to  in Article 3 of Regulation 
(EU) 2023/1182. 

7 

 
 
 
 
Article 3 

1. 

2. 

3. 

4. 

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

The competent authorities of the United Kingdom in respect of Northern Ireland may 
allow  medicinal  products  as  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), 
first subparagraph, 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  as  referred  to  in  Article  1(1)  of  this 
Regulation. 

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

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

5. 

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

(a) 

(b) 

6. 

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

keep records as regards the information referred to in Article 80, first paragraph, point 
(e), last indent, of Directive 2001/83/EC. 

For all supplies of medicinal products as 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  that  makes  it  possible  to  ascertain  the  batch  number  of  the  medicinal 
products in accordance with Article 82, first paragraph, last indent, of that Directive. 

According  to  the  written  guarantees,  pursuant  to  the  revised  UK  Human  Medicines 
Regulations  2012,  as  of  1  January  2025,  safety  features  within  the  meaning  of Article  54, 
point (o), of Directive 2001/83/EC will be prohibited on the outer packaging or, where there is 
no outer packaging, on the immediate packaging of medicinal products. Any features included 
for  the  purposes  of  compliance  with  EU  Falsified  Medicines  Directive  (EU  FMD) 
requirements  would  have  to  be  removed  or  covered.  MAHs  would  have  to  update  their 
artwork accordingly at the next regulatory opportunity. 

8 

 
 
The  European  Medicines  Verification  Organisation  (EMVO)  would  disconnect  the  UK(NI) 
National  Medicines Verification System (NMVS) from  the European Medicines Verification 
System  (EMVS)  on  1  January  2025  and  SecurMed  (UK(NI)  Medicines  Verification 
Organisation)  would  decommission  the  UK(NI)  NMVS  on  the  same  date.  As  all  data  for 
historically  uploaded  UK  packs  will  be  deleted  and  no  longer  accessible  in  the  system,  any 
attempt to scan a historic Northern Ireland pack elsewhere in the Union should return an error 
message. 

In  this  respect,  packs  released  after  1  January  2025  should  not  carry  a  barcode  that  is 
recognised by the Union system, and any such code present would need to be fully removed 
or covered, in  line with  the relevant  guidance published by the MHRA. (9) The MHRA has 
also  published  appropriate  guidance  on  the  legal  obligations  for  Qualified  Persons  in  this 
respect. (10) 

Pharmaceutical  wholesalers  and  manufacturers  in  Northern  Ireland  would  be  inspected  by 
GMDP  inspectors  to  ensure  the  labelling  requirements  are  met. Where  deviations  would  be 
identified,  compliance  actions  would  be  required  by  MHRA  inspectors  and  MRG  would  be 
informed. Furthermore, MRG Inspectors would inspect other entities at the end of the supply 
chain such as community and hospital pharmacies, private hospitals and NHS hospitals. Part 
of these visits would assess medicines in stock and ensure that all medicines are appropriately 
labelled. Where deficiencies would be identified, corrective actions would be taken to ensure 
compliance, including seizure of non-compliant products. This information would be shared 
with  the  MHRA  to  ensure  the  integrity  of  the  medicines  supply  chain  and  compliance  with 
applicable Union Regulations. 

The  DOH  would  also  provide  assurances  to  the  MHRA  that  appropriate  monitoring  and 
enforcement controls are in place as required by law, to ensure compliance with Article 3 of 
Regulation (EU) 2023/1182, in areas that are within DOH’s responsibility. 

In view of the above guarantees, the Commission considers the measures taken by the United 
Kingdom in respect of Northern Ireland adequate, as the appropriate legal measures have been 
taken, guidance has been published for stakeholders and appropriate procedures are in place 
to ensure that the Union safety features do not appear on the outer or immediate packaging of 
medicinal  products  or,  where  they  appear,  that  they  are  fully  removed  or  covered.      This 
would  ensure  conformity  with  the  specific  rules  set  out  in  Article  3  of  Regulation  (EU) 
2023/1182,  which  is  necessary  to  effectively  reach  the  public  health  aim  pursued  and  to 
ensure  that  the  medicinal  products  placed  on  the  market  in  Northern  Ireland    are  easily 

(9)   Labelling and packaging of medicinal products for human use following agreement of the Windsor 

Framework (https://www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-
for-human-use-following-agreement-of-the-windsor-framework/labelling-and-packaging-of-medicinal-
products-for-human-use-following-agreement-of-the-windsor-framework). 

(10)  Wholesalers  &  manufacturers  guidance 

following 
(https://www.gov.uk/government/publications/wholesalers-manufacturers-guidance-following-agreement-
of-the-windsor-framework/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-
framework#guidance-for-qps). 

agreement  of 

the  Windsor  Framework 

9 

 
 
 
distinguishable  from  those  placed  on  the  Union  market,    Also,  effective  monitoring, 
enforcement  and  controls  of  the  specific  rules  laid  down  in  Article  3  of  Regulation  (EU) 
2023/1182 have been put in place and are carried out, by means of, inter alia, inspections and 
audits” 

2.3.  Guarantees as regards Article 4 of Regulation (EU) 2023/1182 
This section addresses specifically the measures presented in the written guarantees to comply 
with the requirement that effective monitoring, enforcement and controls of the specific rules 
laid  down  in  Article  4  of  Regulation  (EU)  2023/1182  are  in  place  and  are  carried  out,  by 
means of, inter alia, inspections and audits. 

Article 4 

Specific rules for medicinal products as 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) 

(b) 

(c) 

A medicinal product as 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. 

Notwithstanding  paragraph  1  of  this  Article,  a  medicinal  product  as  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 provided that all of the following conditions are fulfilled: 

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

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

written  guarantees  are  provided  by  the  United  Kingdom  to  the  Commission  in 
accordance with Article 8 of this Regulation. 

The Commission notes that with the revision of the UK Human Medicines Regulation of 2012 
the United Kingdom has taken the necessary measures to ensure that medicines falling within 
the scope of Regulation 726/2004 would be placed on the market in Northern Ireland only if 
they are authorised by the authorities of the United Kingdom.  

The  Commission  acknowledges  that,  according  to  the  written  guarantees,  the  routine 
inspection programme would be updated to include compliance and enforcement actions that 
would  be  undertaken  to  ensure  compliance  with  Good  Manufacturing  and  Distribution 
Practices. In accordance with Article 4(1) of Regulation (EU) 2023/1182, medicinal products 
authorised under Union law would no longer be authorised for supply in Northern Ireland and 

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would  have  to  comply  with  UK  law  as  of  1  January  2025,  which  would  be  verified  during 
routine GMDP inspections. Furthermore, the UK’s inspections programme would be updated 
to include the requirements of Regulation (EU) 2023/1182 and inspectors would be trained to 
assess  the  implementation  of  these  new  requirements  accordingly.  The  United  Kingdom 
would include in their risk-rating of inspections a focus on MAH who have not changed their 
artwork with the “UK only” label and related requirements accordingly. 

The written guarantees include several enforcement options should a breach of the applicable 
rules  be  identified  during  enforcement  or  inspections  actions,  which  would  be  carried 
according to a risk-based approach. The Commission considers the proposed actions adequate 
and necessary. The United Kingdom reported that enforcement actions would be carried out in 
proportion to the potential harm or severity of the breach. These enforcement options would 
include written warnings, advice or guidance to the economic operator and implementation of 
an inspection programme at first instance. Should the economic operator fail to comply with 
the UK legislative requirements for medicinal products for human use and not take corrective 
actions, formal actions would be taken by involving Professional Regulatory bodies to decide 
on a potential prosecution. 

In  view  of  the  above  guarantees,  the  Commission  considers  that  the  measures  taken  by  the 
United Kingdom in respect of Northern Ireland appear to provide for the effective monitoring, 
enforcement  and  controls  of  the  specific  rules  laid  down  in  Article  4  of  Regulation  (EU) 
2023/1182  as  the  appropriate  legal  measures  have  been  taken,  related  guidance  has  been 
published and appropriate procedures are in place. 

CONCLUSION 

3. 
The written guarantees submitted by the United Kingdom pursuant to Article 8 of Regulation 
(EU)  2023/1182  provide  reasonable  assurance  that,  subject  to  effective  enforcement  by  the  
authorities  of  the  United  Kingdom,  the  placing  on  the  market  of  medicinal  products  as 
referred to in Article 1(1) will not increase the risk to public health in the internal market and 
that such medicinal products will not be moved to a Member State. 

The written guarantees also provide reasonable assurance that: 

i. 

ii. 

iii. 

economic operators will comply with the labelling requirements laid down in Article 5 
of Regulation (EU) 2023/1182; 

the safety features referred to in Article 54, point (o), of Directive 2001/83/EC will not 
appear on the outer packaging or, where there is no outer packaging, on the immediate 
packaging  of  medicinal  products  as  referred  to  in  Article  1(1)  of  Regulation  (EU) 
2023/1182. 

effective  monitoring,  enforcement  and  controls  of  the  specific  rules  laid  down  in 
Articles 3, 4 and 5 of Regulation (EU) 2023/1182 will be in place and carried out, by 
means of, inter alia, inspections and audits. 

As  provided  for  in  Article  9(1)  of  Regulation  (EU)  2023/1182,  the  Commission  will 
continuously monitor the application by the United Kingdom of the specific rules relating to 

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medicinal products for human use intended to be placed on the market in Northern Ireland, in 
particular those laid down in Articles 3, 4 and 5 of the Regulation. In this respect the United 
Kingdom  has  committed  in  the  written  guarantees  to  supply,  upon  request,  relevant 
information related to the activities undertaken in support of the written guarantees. 

Article  9  of  Regulation  (EU)  2023/1882  also  provides  for  a  specific  mechanism  to  address 
any serious or repeated infringements of those specific rules and empowers the Commission 
to take appropriate measures if those infringements are not remedied. 

In light of the above conclusions and in accordance with the fifth subparagraph of Article 14 
of Regulation (EU) 2023/1182, the Commission will publish a notice in the Official Journal of 
the European Union indicating that the Regulation will apply as from 1 January 2025. 

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