Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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, as well as in Cyprus, Ireland and Malta
Date: 2021-12-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Cyprus, Ireland, Malta, Northern Ireland, United Kingdom, clinical trial, import, import licence, market approval, medicinal product, security of supply

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   EUROPEAN COMMISSION  Brussels, 17.12.2021  COM(2021) 997 final 2021/0431 (COD)  Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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, as well as in Cyprus, Ireland and Malta (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Pursuant  to  the  Protocol  on  Ireland  /  Northern  Ireland  (“the  Protocol”)  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  Community1 
(“the Withdrawal Agreement”), medicines placed on the market in Northern Ireland  
must be covered by a valid marketing authorisation issued by the Commission (EU-
wide  authorisations)  or  the  United  Kingdom  (UK)  in  respect  of  Northern  Ireland. 
These national authorisations shall be in compliance with the obligations of  the EU 
acquis for medicinal products. 

During these last years, the UK as well as the small markets of the European Union 
(i.e. Malta, Ireland and Cyprus) that are dependent on supply of medicinal products 
from the United Kingdom have raised issues with respect to the ability of economic 
operators to comply with all provisions of the acquis for medicines after the end of 
the transition period provided for in the Withdrawal Agreement (de facto mostly for 
generics  and  over-the-counter  medicines).  There  are 
two  possible  national 
authorisation  routes:    purely  UK  national  authorisations  (“Northern  Ireland-only 
authorisations”),  which  concern  medicines  that  are  made  available  in  Northern 
Ireland  only,  and  UK  national  authorisations  issued  under  Union  law  procedures 
involving  at  least  another  Member  State  (Mutual  Recognition  or  Decentralised 
Procedures2). 
The Commission Notice of 25 January 20213 provides for a grace period of one year 
(until  end-December  2021)  for  maintaining  batch  testing  and  manufacturing  / 
logistics  in  parts  of  the  United  Kingdom  other  than  Northern  Ireland  to  ensure 
undisrupted supply of medicines to Northern Ireland, Cyprus, Ireland and Malta.4  

Despite  the  transition  period,  it  still  proves  very  difficult  for  certain  operators 
currently based in parts of the United Kingdom 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  pharmacovigilance)  to  Northern  Ireland  or  the  EU  in  respect  of 
nationally authorised products, as required by the Protocol.  The main reasons are the 

1  OJ L 29, 31.1.2020, p. 7. 

2  Under these procedures, a Member State takes the lead in the assessment  (“Reference  Member State”) and 
issues  the  first  authorisation,  on  the  basis  of  which  identical  national  authorisations  are  then  issued  by  the 
other  Concerned  Member  States.  Pursuant  to  the  Protocol,  Northern  Ireland  participates  in  these  two 
procedures but the UK cannot have the leading role. 

3  Commission Notice of 25 January 2021 on the application of the Union’s pharmaceutical acquis in markets 
historically  dependent  on  medicines  supply  from  or  through  Great  Britain  after  the  end  of  the  transition 
period, OJ C 27, 25.1.2021, p. 11.  

4  The  current  flexibilities  allow:  (i)  wholesale  distributors  in  Northern  Ireland,  Cyprus,  Ireland  and  Malta  to 
place medicinal products imported from other parts of the United Kingdom than Northern Ireland without the 
manufacturing authorisation required for imports from third countries; (ii) batch testing normally required to 
be carried out in the Union (or Northern Ireland pursuant to the Protocol) before placing medicinal products 
on the market to take place in other parts of United Kingdom than Northern Ireland; (iii) derogations relating 
to the placement of the unique identifier for medicines for human use. 

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too high adjustment costs relative to the small size of the Northern Irish market and 
the  complex  logistics  involved,  for  which  no  viable  alternative  logistical  hubs  in 
Northern Ireland have been identified.  

By  the  same  token,  most  industry  players  currently  based  in  parts  of  the  United 
Kingdom  other  than  Northern  Ireland  are  not  prepared  to  make  the  necessary 
regulatory  changes  to  continue  to  serve  the  EU  Member  States  (Cyprus,  Ireland, 
Malta) that have been traditionally dependent on medicines supply from  or through 
parts  of  the  United  Kingdom  other  than  Northern  Ireland.  Medicines  for  these 
markets are still mainly distributed by wholesalers with logistical hubs in parts of the 
United Kingdom other than Northern Ireland. The common English leaflet in United 
Kingdom in respect of Northern Ireland, Cyprus, Ireland and Malta is also one of the 
element that industry wants to preserve.  

The  objectives  of  this  proposal  are  to  address  the  issues  related  to  the  human 
medicinal products,  to  prevent  shortages of medicines and ensure adequate level  of 
public health protection in Northern Ireland, Cyprus, Ireland and Malta. 

This proposal allows exceptionally that: 

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A  marketing  authorisation  holder  may  be  established  in  parts  of  the  United 
Kingdom other than Northern Ireland; 

The manufacturing authorisation holder  may be located in parts of the United 
Kingdom other than Northern Ireland; 

The batch testing may be carried out in parts of the United Kingdom other than 
Northern Ireland; 

The qualified person  for  batch testing and pharmacovigilance  may be located 
in parts of the United Kingdom other than Northern Ireland; 

An EU wholesaler located in Northern Ireland, Cyprus, Ireland, or Malta may 
purchase  and  obtain  medicines  from  a  third  country  (parts  of  the  United 
Kingdom other than Northern Ireland) without holding a manufacturing import 
authorisation and without re-testing the products. 

The Union has an agile system to authorise new and innovative medicinal products 
through the centralised procedure provided by Regulation (EC) No 726/2004. Those 
medicinal  products  will be  available  to  patients  in  Northern  Ireland.  However,  it  is 
possible  that  for  some  of  these  products  the  competent  authorities  of  the  United 
Kingdom in respect of other parts of the United Kingdom than Northern Ireland issue 
a marketing authorisation, while there is no marketing authorisation granted yet  for 
the same medicinal product in the Union. In such an exceptional case, the competent 
authorities  of  the  United  Kingdom  in  respect  of  Northern  Ireland  would  be  able  to 
supply those medicinal products to patients in Northern Ireland temporarily and until 
a  marketing  authorisation  is  granted  or  refused  in  the  Union.  Those  temporary 
authorisations  should  be  time  limited  and  cease  in  any  case  once  a  decision  on  the 
medicinal product is taken by the Commission to grant or refuse the authorisation to 
market that product.  

In addition, if an application for marketing authorisation is submitted in one or more 
Member  States  and  in  the  United  Kingdom  in  respect  of  Northern  Ireland,  or  if  an 
application  for  marketing  authorisation  is  submitted  in  the  United  Kingdom  in 
respect of Northern Ireland for a medicinal product which is already being examined 
or  has  already  been  authorised  in  a  Member  State,  the  proposal  provides  that  the 

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applicant  may  choose  between  the  mutual  recognition/decentralised  procedure  and 
the national authorisation procedure in respect of Northern Ireland. 

Likewise,  the  proposal  provides  that  the  marketing  authorisation  holder  of  a 
medicinal product for which a marketing authorisation has already been granted for 
the  United  Kingdom  in  respect  of  Northern  Ireland  in  accordance  with  the  mutual 
recognition or decentralised procedure may withdraw the marketing authorisation for 
the United Kingdom in respect of Northern Ireland from the mutual recognition and 
decentralised  procedure  and  to  submit  an  application  for  a  marketing  authorisation 
for that medicinal product to the competent authorities of the United Kingdom with 
respect to Northern Ireland in accordance with the national authorisation procedure. 

For Cyprus, Ireland and Malta, derogations are temporary as it is expected that these 
markets will gradually be supplied through Member States. A transition period of 3 
years therefore seems sufficient.  

• 

Consistency with existing policy provisions in the policy area 

A comprehensive Union medicinal products legislative framework is established, in 
particular Directive 2001/83/EC 5 and Directive 2001/20/EC6, which are of relevance 
for this initiative that will complement and amend them. 

This  proposal  is  consistent  with  the  objective  to  protect  public  health  in  the  small 
markets of the Union and in Northern Ireland. 

• 

Consistency with other Union policies 

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

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

As the initiative amends Directive 2001/83/EC and Directive 2001/20/EC, the same 
legal  basis    Article  114  TFEU    is  considered  the  appropriate  legal  basis  for  this 
proposal as well. 

• 

Subsidiarity (for non-exclusive competence)  

This  proposal  provides  exemptions  to  the  provisions  of  the  EU  pharmaceutical 
legislation and can only be achieved by an amendment of the  relevant basic acts at 
EU level.  

The European Commission has explored the possibility given by the implementation 
of  Article  5  of  Directive  2001/83/EC  to  use  non-compliant  medicines  under  the 
compassionate use procedure for the purposes of medicines supply to Cyprus, Ireland 
and Malta. 

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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). 
Directive  2001/20/EC  of  the  European  Parliament  and  of  the  Council  of  4  April  2001  on  the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the implementation of good clinical practice in the conduct of clinical trials on medicinal products for 
human use (OJ L 121, 1.5.2001, p. 34). 

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Nevertheless, the competent authorities of the Member States concerned do not want 
to transfer the liability arising from these derogations to the healthcare professionals. 
Moreover,  the  compassionate  use  should  be  restricted  to  a  limited  number  of 
medicinal products on a case-by-case basis under certain circumstances.  

This  proposal  aims  to  provide  derogations  for  medicinal  products  distributed  to 
Northern Ireland, Cyprus, Ireland and Malta.  

• 

Proportionality 

The  proposal  covers  the  exemptions  for  regulatory  functions  that  had  not  been 
transferred by industry to the EU or Northern Ireland before the end of the transition 
period provided for in the Withdrawal Agreement. This proposal is not going beyond 
what  is  absolutely  necessary  to  ensure  continued  supply  of  medicinal  products  (for 
human use). 

The  proposal  is  restricted  to  medicinal  products  made  exclusively  available  in 
Northern Ireland and the small markets of the Union that are dependent  on the UK 
market for their medicine supplies. 

• 

Choice of the instrument 

As the initiative amends Directive 2001/83/EC and Directive 2001/20/EC, a proposal 
for a Directive of the European Parliament and Council is considered the appropriate 
instrument. 

3. 

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RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

Not applicable 

Stakeholder consultations 

This initiative is proposed following bilateral discussion with the concerned national 
authorities and industry, wholesale distributors and pharmacists, who have expressed 
strong concern due to the risk of shortages of medicines supplies. 

Impact assessment 

The  proposal  is  exempted  from  the  impact  assessment  due  to  the  urgency  of  the 
situation, to ensure public health through the continued supply of medicinal products 
in Northern Ireland and the small markets of the Union that are dependent on the UK 
for their supplies. 

Regulatory fitness and simplification 

By  waiving  certain  regulatory  requirements  for  the  importation  of  medicinal 
products, provided certain conditions  are fulfilled, the proposal reduces  compliance 
costs in particular as regards the SMEs.  

Fundamental rights 

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

4. 

BUDGETARY IMPLICATIONS 

No budgetary implications are foreseen.  

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5. 

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OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The  initiative  applies  to  UK  in  respect  of  Northern  Ireland  that  must  implement  it 
and must notify to the Commission the implementation planning associated with this 
initiative. The Member States concerned as well must take the necessary measures to 
implement  the  initiative.  The  Commission  will  further  monitor  its  implementation 
via  the  supervision  and  control  mechanism  set  therein,  with  the  support  of  the 
competent authorities of the Member States.  

Explanatory documents (for directives) 

The Member States concerned shall transpose this proposal within the set timeframe 
and take the necessary measures to comply with this Directive. 

Detailed explanation of the specific provisions of the proposal 

Not applicable for this proposal. 

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2021/0431 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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, as well as in Cyprus, Ireland and Malta 

(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 Committee, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

The  Agreement  on  the  withdrawal  of  the  United  Kingdom  of  Great  Britain  and 
Northern  Ireland  from  the  European  Union  and  the  European  Atomic  Energy 
Community1 (the ‘Withdrawal Agreement’) was concluded on behalf of the Union by 
Council  Decision  (EU)  2020/135 2 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  (the  ‘transition  period’),  ended  on  31 
December  2020.  On  25  January  2021,  the  Commission  issued  a  Notice3  on  the 
application of the Union’s pharmaceutical acquis in markets historically dependent on 
medicines  supply  from  or  through  Great  Britain,  namely  Cyprus,  Ireland,  Malta  and 
Northern Ireland, from the end of the transition period until 31 December 2021.  

(2) 

In accordance with the Protocol on Ireland/Northern Ireland, which forms an integral 
part  of  the  Withdrawal  Agreement,  medicinal  products  placed  on  the  market  in 
Northern Ireland are to comply with Union law. 

1 
2 

3 

OJ L 29, 31.1.2020, p. 7. 
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). 

Commission  Notice  -  Application  of  the  Union’s  pharmaceutical  acquis  in  markets  historically 
dependent  on  medicines  supply  from  or  through  Great  Britain  after  the  end  of  the  transition  period 
2021/C 27/08 (OJ C 27, 25.1.2021, p. 11). 

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(3) 

(4) 

(5) 

(6) 

Directives  2001/20/EC4  and  2001/83/EC5  of  the  European  Parliament  and  of  the 
Council lay down the rules for medicinal products for human use and investigational 
medicinal products intended to be placed on the market in the Member States. 

Cyprus,  Ireland,  Malta  and  Northern  Ireland  have  historically  relied  on  supply  of 
medicinal products from or through parts of the United Kingdom other than Northern 
Ireland,  and  the  supply  chains  for  these  markets  have  not  yet  been  fully  adapted  to 
comply with Union law. In order to prevent shortages of medicines and ultimately to 
ensure a high level of public health protection, Directives 2001/20/EC and 2001/83/EC 
need to be amended to provide for derogations for the medicinal products supplied to 
Cyprus, Ireland, Malta and Northern Ireland from parts of the United Kingdom other 
than  Northern  Ireland.  In  order  to  ensure  uniform  application  of  Union  law  in  the 
Member States, the derogations applicable in Cyprus, Ireland and Malta should be of a 
temporary nature only. 

In accordance with Article 13(1) of Directive 2001/20/EC read in conjunction with the 
Protocol, the import of investigational medicinal products from third countries into the 
Union or Northern Ireland is subject to the possession of a manufacturing and import 
authorisation.  In  order  to  ensure  continued  access  to  new,  innovative  or  improved 
treatments  for  clinical  trial  participants  in  Northern  Ireland,  as  well  as  in  Cyprus, 
Ireland  and  Malta  after  31  December  2021,  the  manufacturing  and  import 
authorisation  should  not  be  required  for  investigational  medicinal  products  imported 
into  those  markets  from  parts  of  the  United  Kingdom  other  than  Northern  Ireland, 
provided that certain conditions are fulfilled. In order to ensure uniform application of 
Union  law  in  the  Member  States,  the  derogations  applicable  in  Cyprus,  Ireland  and 
Malta should be of a temporary nature only. 
Regulation  (EC)  No  726/2004  of  the  European  Parliament  and  of  the  Council6  lays 
the  authorisation  of  medicinal  products.  Upon 
down  Union  procedures  for 
authorisation  in  the  Union,  medicinal  products  are  available  to  patients  in  Northern 
Ireland. However, it is possible that for some of the medicinal products the competent 
authorities  of  the  United  Kingdom  in  respect  of  parts  of  the  United  Kingdom  other 
than  Northern  Ireland  issue  a  marketing  authorisation,  while  there  is  no  marketing 
authorisation  granted  yet  for  the  same  medicinal  product  in  the  Union.  In  such 
exceptional cases, and in order to ensure that patients in Northern Ireland have access 
to  those medicinal products  at  the same time  as  patients  in other parts of the United 
Kingdom,  the  competent  authorities  of  the  United  Kingdom  in  respect  of  Northern 
Ireland  should  be  able  to  supply  those  medicinal  products  to  patients  in  Northern 
Ireland  temporarily  and  until  a  marketing  authorisation  is  granted  or  refused  in  the 
Union.  In  order  to  ensure  the  full  effectiveness  of  the  centralised  procedure  for 
granting  marketing  authorisations  as  set  out  in  Regulation  (EC)  No  726/2004,  those 
temporary  authorisations  should  be  limited  in  time  and  should  cease  when  the 

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Directive  2001/20/EC  of  the  European  Parliament  and  of  the  Council  of  4  April  2001  on  the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the implementation of good clinical practice in the conduct of clinical trials on medicinal products for 
human use (OJ L 121, 1.5.2001, p. 34). 
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). 
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). 

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(7) 

(8) 

(9) 

Commission  takes  a  decision  to  grant  or  refuse  the  authorisation  to  market  that 
medicinal product.  

In accordance with Article 8(2) of Directive 2001/83/EC, read in conjunction with the 
Protocol, a marketing authorisation may only be granted to an applicant established in 
the  Union  or  in  Northern  Ireland.  A  number  of  operators  have  not  yet  been  able  to 
comply with this requirement and it is not likely that they will be able to do so by 31 
December 2021. To ensure access to certain medicines in Northern Ireland, it is crucial 
that  the  holders  of  marketing  authorisations  issued  by  the  national  authorities  of  the 
United Kingdom in respect of Northern Ireland are allowed to be established in parts 
of  the  United  Kingdom  other  than  Northern  Ireland.  Similarly,  to  ensure  access  to 
certain  medicines  in  Cyprus,  Ireland,  Malta  and  Northern  Ireland,  it  is  necessary  to 
allow  the  national  competent  authorities  of  Cyprus,  Ireland,  Malta  and  Northern 
Ireland to grant marketing authorisations in the context of the mutual recognition and 
decentralised procedures to marketing authorisation holders established in parts of the 
United Kingdom other than Northern Ireland. 

It follows from Articles 17 and 18 of Directive 2001/83/EC, read in conjunction with 
the Protocol, that applicants for marketing authorisation wishing to obtain a marketing 
authorisation for the United Kingdom in respect of Northern Ireland as well as for one 
or  more  Member  States  need  to  include  the  United  Kingdom  in  respect  of  Northern 
Ireland in the scope of their marketing authorisation application in accordance with the 
decentralised  procedure  or  the  mutual  recognition  procedure.  Where  medicinal 
products  are  also  authorised  in  parts  of  the  United  Kingdom  other  than  Northern 
Ireland,  the  requirement  to  comply  with  this  obligation  may  hamper  the  continuous 
access to medicines for patients in Northern Ireland. To avoid this,  it is necessary to 
allow  applicants  in  such  situations  the  possibility  to  apply  for  a  marketing 
authorisation  for  the  United  Kingdom  in  respect  of  Northern  Ireland  either  in 
accordance with the mutual recognition or decentralised procedures or in accordance 
with  the  national  marketing  authorisation  procedure  applicable  in  relation  to  the 
United  Kingdom  in  respect  of  Northern  Ireland.  In  the  latter  case,  the  marketing 
authorisation  should  be  granted  in  compliance  with  Union  law,  including  the 
requirements on the quality, safety and efficacy of medicinal products. 

In  accordance  with  Article  51(1),  point  (b),  of  Directive  2001/83/EC,  medicinal 
products imported into the Union have to undergo quality control testing in the Union. 
Article 20, point (b), of that Directive allows the importers placing medicinal products 
supplied from or through parts of the United Kingdom other than Northern Ireland on 
the  market  in  Cyprus,  Ireland,  Malta  or  Northern  Ireland  or  wholesale  distributors 
placing such medicinal products on those markets to have, in justifiable cases, certain 
controls  carried  out  in  parts  of  the  United  Kingdom  other  than  Northern  Ireland. 
Taking into account the historical dependence of Cyprus, Ireland, Malta and Northern 
Ireland on medicines supply from other parts of the United Kingdom and the related 
risks  of  shortages  of  medicines  in  those  jurisdictions,  a  ‘justifiable  case’  within  the 
meaning  of  Article  20,  point  (b),  of  Directive  2001/83/EC  should  be  considered  to 
occur when each batch of the medicinal product concerned is released by a qualified 
person on a site in the Union or by a qualified person on a site in parts of the United 
Kingdom  other  than  Northern  Ireland  applying  equivalent  quality  standards  to  those 
laid  down  in  Union  law,  thus  ensuring  an  equivalent  level  of  protection  of  human 
health.  Given  that  Article  20,  point  (b),  of  Directive  2001/83/EC  only  provides  for 
batch testing to be carried out in a third country on a case-by-case basis, it is necessary 
to lay down conditions harmonising the implementation of that provision with regard 

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(10) 

to  medicinal  products  supplied  to  Cyprus,  Ireland,  Malta  and  Northern  Ireland  from 
parts of the United Kingdom other than Northern Ireland. 

It  follows  from  Article  40(3)  of  Directive  2001/83/EC,  read  in  conjunction  with  the 
Protocol,  that  importers  of  medicinal  products  from  third  countries  into  a  Member 
State needs to hold a manufacturing authorisation issued by the Member State where 
the importer is established or, in the case of importers established in Northern Ireland, 
by  the  United  Kingdom  in  respect  of  Northern  Ireland.  To  avoid  that  operators 
withdraw from or significantly reduce medicines supply to Cyprus, Ireland, Malta and 
Northern Ireland, it is necessary to exceptionally derogate from that requirement under 
certain conditions and to allow imports of medicinal products from parts of the United 
Kingdom other than Northern Ireland into Cyprus, Ireland, Malta and Northern Ireland 
by  wholesale  distributors  that  do  not  hold  a  manufacturing  authorisation  otherwise 
required for import, while ensuring an equivalent level of protection of human health.  

(11) 

In  addition,  in  the  situation  where  a  medicinal  product  is  exported  from  a  Member 
State  to  parts  of  the  United  Kingdom  other  than  Northern  Ireland,  and  subsequently 
imported  into  Cyprus,  Ireland,  Malta  or  Northern  Ireland,  it  should  be  possible  to 
waive specific controls  (quality control testing) to guarantee the quality of medicinal 
products  imported  from  third  countries  provided  that  appropriate  arrangements  have 
been  made  by  the  Union  to  ensure  that  the  necessary  controls  are  carried  out  in  the 
exporting country.  

(12)  Article 48 of Directive 2001/83/EC,  read in  conjunction with  its  Article 49 and with 
the Protocol, is understood as requiring that the marketing authorisation holder to have 
at  its  disposal  a  qualified  person  is  established  in  and  operating  from  the  Union  or 
Northern  Ireland.  To  ensure  a  continuous  access  to  certain  medicines  to  patients  in 
Northern  Ireland, it is  appropriate to  allow the  qualified person  responsible  to  reside 
and operate in parts of the United Kingdom other than Northern Ireland. 

(13) 

It follows from Article 104(3) of Directive 2001/83/EC, read in conjunction with the 
Protocol,  that  the  qualified  person  responsible  for  pharmacovigilance  needs  to  be 
established in and operate from the Union or Northern Ireland. A number of operators 
have not yet been able to comply with this requirement, it is not likely that they will be 
able  to  do  so  by  31  December  2021.  To  ensure  that  access  to  certain  medicines  for 
patients  in  Northern  Ireland  is  not  hampered,  it  is  appropriate  to  allow  the  qualified 
person  responsible  for  pharmacovigilance  to  be  established  in  parts  of  the  United 
Kingdom other than Northern Ireland. 

(14)  To  avoid  shortages  of  medicines  in  Cyprus  and  Malta,  the  competent  authorities  of 
Cyprus  and  Malta  should  be  allowed,  for  public  health  reasons  and  for  a  certain 
period, to grant, maintain in force and extend marketing authorisations on the basis of  
Article  126a  of  Directive  2001/83/EC  which  are  relying  on  marketing  authorisations 
granted  by  the  competent  authorities  of  parts  of  the  United  Kingdom  other  than 
Northern Ireland, even if the marketing authorisation holder is no longer established in 
the  Union,  provided  that  certain  conditions  are  fulfilled.  Given  that  Union  law  no 
longer  applies  in  parts  of  the  United  Kingdom  other  than  Northern  Ireland,  it  is 
necessary to provide that the competent authorities of Cyprus and Malta shall ensure 
that such authorisations comply with Union law.In order to ensure that the functioning 
of the Union market  is  not  undermined it  is  necessary to  establish the  conditions for 
enhanced supervision and enforcement of the rules relevant for the application of the 
this  Directive.  The  Commission,  should  monitor 
derogations 
developments in parts of the United Kingdom  other than Northern Ireland that could 

introduced  by 

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affect  the  level  of  protection  regarding  the  regulatory  functions  covered  by  this 
Directive. If the Commission finds that the level of protection of public health ensured 
by the United Kingdom  through rules  governing the production, distribution and use 
of medicinal products as well as the effective enforcement of those rules is no longer 
essentially  equivalent  to  that  guaranteed  within  the  Union,  or  if  the  Commission  is 
lacking  information  to  assess  whether  an  essentially  equivalent  level  of  protection  is 
guaranteed, the Commission  should enter in  consultations with the United Kingdom, 
to find a mutually agreed remedy to that situation. If such remedy is not found within a 
prescribed  period,  the  Commission  should,  as  a  last  resort,  be  empowered  to  adopt 
delegated acts suspending the application of one or more provisions of this Directive.  

(15) 

In  order  to  ensure  transparency,  the  competent  authorities  of  Cyprus,  Ireland,  Malta 
and  the  United  Kingdom  in  respect  of  Northern  Ireland  should  publish  a  list  of 
products  to  which  they  intend  to  apply  or  have  applied  the  derogations  as  set  out  in 
this  Directive.  In  order  to  make  the  information  easily  searchable,  that  list  should 
contain the same information as included in the package leaflet or summary of product 
characteristics of the medicinal products concerned. 

(16)  Directives  2001/20/EC  and  Directive  2001/83/EC  should  therefore  be  amended 

accordingly. 

(17) 

In order to ensure legal continuity for operators active in the pharmaceutical sector and 
to guarantee the continuous access of patients in Cyprus, Malta, Ireland and Northern 
Ireland  to  medicinal  products,  this  Directive  should  enter  into  force  as  a  matter  of 
urgency  and  the  measures  adopted  by  the  Member  States  to  comply  with  it  should 
apply retroactively from 1 January 2022, 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

In Article 13(1) of Directive 2001/20/EC, the following subparagraph is added:  

“By  way  of  derogation  from  the  first  paragraph  the  competent  authorities  of  the  United 
Kingdom  in  respect  of  Northern  Ireland  and,  until  31  December  2024,  the  competent 
authorities of Malta, Cyprus and Ireland shall allow investigational medicinal products to be 
imported  from  parts  of  the  United  Kingdom  other  than  Northern  Ireland  without  a 
manufacturing and import authorisation, provided that the following conditions are fulfilled:  

(a) 

(b) 

the medicinal products imported into Cyprus, Ireland, Malta or Northern Ireland have 
undergone  certification  of  batch  release  either  in  the  Union,  as  provided  for  in 
paragraph 3, point (a), or in parts of the United Kingdom other than Northern Ireland 
in compliance with the requirements set out in paragraph 3, point (b);  

the  investigational  medicinal  products  are  only  made  available  to  clinical  trial 
participants in the Member State into which the medicinal products are imported, or, 
if imported into Northern Ireland, are only made available to clinical trial participants 
in Northern Ireland.” 

Directive 2001/83/EC is amended as follows: 

(1) 

the following Article 5a is inserted: 

Article 2 

EN 

“Article 5a 

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By  way  of  derogation  from  Article  6,  the  competent  authorities  of  the  United 
Kingdom  in  respect  of  Northern  Ireland  may  temporarily  authorise  the  supply  to 
patients  in  Northern  Ireland  of  a  medicinal  product  belonging  to  the  categories 
referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 provided that the 
following conditions are fulfilled: 

(a) 

(b) 

the medicinal product concerned has been granted a marketing authorisation by 
the  competent  authority  of  the  United  Kingdom  for  parts  of  the  United 
Kingdom other than Northern Ireland; 

the  medicinal  product  concerned  is  only  made  available  to  patients  or  end-
consumers in the territory of Northern Ireland and is not made available in any 
Member State. 

The  maximum  validity  of  the  temporary  authorisation  shall  be  6  months. 
Notwithstanding the specified validity, the temporary authorisation shall cease when 
the  medicinal  product  concerned  has  been  granted  a  marketing  authorisation  in 
accordance  with  Article  10  of  Regulation  (EC)  No  726/2004,  or  when  such 
marketing authorisation has been refused in accordance with that Article.”; 

(2) 

in Article 8(2), the following paragraphs 2a and 2b are inserted: 

“2a.  By  way  of  derogation  from  paragraph  2,  a  marketing  authorisation  may  be 
granted  by  the  competent  authorities  of  the  United  Kingdom  in  respect  of 
Northern  Ireland  to  an  applicant  established  in  parts  of  the  United  Kingdom 
other than Northern Ireland. 

2b.  By  way  of  derogation  from  paragraph  2,  marketing  authorisations  may  be 
granted  by  the  competent  authorities  of  the  United  Kingdom  in  respect  of 
Northern Ireland and, until 31 December 2024, by the competent authorities of 
Cyprus,  Ireland  and  Malta,  in  accordance  with  the  mutual  recognition  or  the 
decentralised  procedure  laid  down  in  Chapter  IV  of  this  Title,  to  marketing 
authorisation  holders  established  in  parts  of  the  United  Kingdom  other  than 
Northern Ireland. 

The  competent  authorities  of  the  United  Kingdom  in  respect  of  Northern 
Ireland  and,  until  31  December  2024,  the  competent  authorities  of  Cyprus, 
Ireland and Malta, may  extend marketing authorisations already  granted  prior 
to  … [OP:    please  insert  the  date  -  date  of  entry  into  force  of  this  amending 
Directive] to marketing authorisation holders established in parts of the United 
Kingdom other than Northern Ireland. 

The marketing authorisations granted or extended by the competent authorities 
of  Cyprus,  Ireland  or  Malta  in  accordance  with  the  first  and  second 
subparagraph shall expire at the latest on 31 December 2026.”; 

(3) 

the following Article 18a is inserted: 

“Article 18a 

1. 

By  way of derogation from  Article 17(1), second subparagraph, Article 17(2) 
and Article 18, if an application for marketing authorisation is submitted in one 
or  more  Member  States  and  in  the  United  Kingdom  in  respect  of  Northern 
Ireland,  or  if  an  application  for  marketing  authorisation  is  submitted  in  the 
United Kingdom in respect of Northern Ireland for a medicinal product which 
is  already being examined or has already been authorised in  a Member State, 
the  application  regarding  the  United  Kingdom  in  respect  of  Northern  Ireland 

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shall not have to be submitted in accordance with Articles 28 to 39, provided 
that all of  the following conditions are fulfilled: 

(a) 

(b) 

the  marketing  authorisation  for  the  United  Kingdom  in  respect  of 
Northern  Ireland  is  granted  by  the  competent  authority  for  the  United 
Kingdom  in  respect  of  Northern  Ireland  in  compliance with  Union law, 
and  such  compliance  with  Union  law  is  ensured  during  the  validity 
period of that marketing authorisation; 

the  medicinal  products  authorised  by  the  competent  authority  for  the 
United  Kingdom  in  respect  of  Northern  Ireland  are  made  available  to 
patients  or  end-consumers only in  the territory  of Northern  Ireland, and 
they are not made available in any Member State. 

The  marketing  authorisation  holder  of  a  medicinal  product  for  which  a 
marketing  authorisation  has  already  been  granted  for  the  United  Kingdom  in 
respect  of  Northern  Ireland  in  accordance  with  Articles  28  to  39  [before  … 
OP:    please  insert  the  date  -  date  of  entry  into  force  of  this  amending 
Directive]shall  be  allowed  to  withdraw  the  marketing  authorisation  for  the 
United  Kingdom  in  respect  of  Northern  Ireland  from  the  mutual  recognition 
and  decentralised  procedure  and  to  submit  an  application  for  a  marketing 
authorisation  for  that  medicinal  product  to  the  competent  authorities  of  the 
United Kingdom with respect to Northern Ireland in accordance with paragraph 
1.” 

2. 

(4) 

In Article 20, the following paragraph is added: 

“With  regard  to  quality  control  testing  carried  out  in  parts  of  the  United  Kingdom 
other than Northern Ireland regarding medicinal products included in the list referred 
to  in  Article  127d  other  than  those  authorised  by  the  Commission,  the  competent 
authorities  of  the  United  Kingdom  in  respect  of  Northern  Ireland,  and,  until  31 
December  2024,  the  competent  authorities  of  Cyprus,  Ireland  and  Malta  may 
consider that there is a ‘justifiable case’ within the meaning of point (b) of the first 
paragraph, without carrying out a case-by-case assessment provided that: 

(a) 

(b) 

each  batch  of  the  medicinal  products  concerned  is  released  by  a  qualified 
person on a site in the Union or in Northern Ireland or by a qualified person on 
a  site  in  parts  of  the  United  Kingdom  other  than  Northern  Ireland  applying 
quality standards equivalent to those laid down in Article 51;  

the establishment designated by the third party  conducting the quality control 
testing  is  supervised  by  the  competent  authority  of  the  United  Kingdom 
including by performing on-the-spot checks;  

(c)  where the batch release is carried out by a qualified person established in parts 
of  the  United  Kingdom  other  than  Northern  Ireland,  the  manufacturing 
authorisation  holder  declares  that  it  does  not  have  at  its  disposal  a  qualified 
person which is established in the Union on … [OP: Please insert the date of 
the entry into force of this amending Directive].”; 

(5) 

in Article 40, the following paragraph 1a is inserted: 

“1a.  By  way  of  derogation  from  paragraph  1  of  this  Article,  the  competent 
authorities of the United Kingdom in respect of Northern Ireland and, until 31 
December 2024, the competent  authorities of Cyprus,  Ireland and Malta shall 
allow  medicinal  products  to  be  imported  from  parts  of  the  United  Kingdom 

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other than Northern Ireland by holders of a wholesale distribution authorisation 
as  referred  to  in  Article  77(1)  who  are  not  in  possession  of  a  relevant 
manufacturing  authorisation,  provided  that  the  following  conditions  are 
fulfilled:  

(a) 

(b) 

(c) 

the  medicinal  products  have  undergone  quality  control  testing  either  in 
the  Union,  as  provided  for  in  Article  51(3),  or  in  parts  of  the  United 
Kingdom  other  than  Northern  Ireland  in  compliance  with  Article  20, 
point (b);  

the medicinal products have been subject to batch release by a qualified 
person  in  the  Union  in  accordance  with  Article  51(1)  or,  for  medicinal 
products  authorised  by  the  competent  authorities  of  Cyprus,  Ireland, 
Malta and the United Kingdom in respect of Northern Ireland, in parts of 
the  United  Kingdom  other  than  Northern  Ireland  applying  equivalent 
quality standards as those laid down in Article 51(1);  

the marketing authorisation for the medicinal product concerned has been 
issued  in  accordance  with  Union  law,  by  the  competent  authority  of  a 
Member  State  or  by  the  Commission  or,  as  regards  medicinal  products 
placed on the market in Northern Ireland, by the competent authority of 
the United Kingdom in respect of Northern Ireland; 

(d)  medicinal products are only made available to patients or end-consumers 
in the Member State into which the medicinal products are imported, or, 
if imported into Northern Ireland, are only made available to patients or 
end-consumers in Northern Ireland; 

(e) 

the medicinal products bear the safety features  referred to in Article 54, 
point (o). 

Article 80, first subparagraph, point (b), shall not apply to the imports that meet 
the conditions laid down in the first subparagraph.”; 

(6) 

in Article 40, the following paragraph 3a is inserted: 

“3a.  For  batches  of  medicinal  products  which  are  exported  to  parts  of  the  United 
Kingdom  other than Northern  Ireland from a Member State and subsequently 
imported  into  Northern  Ireland  or,  until  31  December  2024,  into  Cyprus, 
Ireland or Malta, the controls  upon importation referred to  Article 51(1), first 
and  second  subparagraphs,  shall  not  be  required,  if  those  batches  have 
undergone such controls  in a Member State prior to being exported to parts of 
the United Kingdom other than Northern Ireland  and if they are accompanied 
by the control reports  referred to in Article 51(1), third subparagraph.” 

(7) 

in Article 48, the following paragraph 3 is added: 

“3.  When the marketing authorisation is granted by the competent authority of the 
United Kingdom in respect of Northern Ireland, the qualified person referred to 
in  paragraph  1  may  reside  in  and  operate  from  parts  of  the  United  Kingdom 
other  than  Northern  Ireland.  This  paragraph  shall  not  apply  where  the 
manufacturing  authorisation  holder  already  has  at  its  disposal  a  qualified 
person which is established in the Union on … [OP: Please insert the date of 
the entry into force of this amending Directive].” 

(8) 

in Article 104(3), the following subparagraph is added: 

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“By  way  of  derogation  from  the  second  subparagraph,  where  the  marketing 
authorisation is granted by the competent authority of United Kingdom in respect of 
Northern  Ireland,  the  qualified  person  referred  to  in  point  (a)  of  the  first 
subparagraph may reside in and operate from parts of the United Kingdom other than 
Northern  Ireland.  This  subparagraph  shall  not  apply  where 
the  marketing 
authorisation holder already has at its disposal a qualified person is established in the 
Union  on  …  [OP:  Please  insert  the  date  of  the  entry  into  force  of  this  amending 
Directive].” 

(9) 

the following Article 111c is inserted: 

“Article 111c 

1. 

The  Commission  shall  continuously  monitor  developments  in  the  United 
Kingdom  that  could  affect  the  level  of  protection  regarding  the  regulatory 
functions  referred  to  in  Articles  8(2a),  8(2b),  20  second  paragraph,  40(1a), 
40(3a),  48(3),  104(3)  and  126c  that  are  carried  out  in  parts  of  the  United 
Kingdom  other  than  Northern  Ireland  taking  into  account,  in  particular,  the 
following elements: 

(a) 

the  rules  governing  the  granting  of  marketing  authorisations,  the 
obligations  of  the  marketing  authorisation  holder,  the  granting  of 
manufacturing  authorisations,  the  obligations  of  the  manufacturing 
authorisation  holder,  the  qualified  person  and  their  obligations,  quality 
control  testing,  batch  release  and  pharmacovigilance  as  laid  down  in 
United Kingdom law;  

(b)  whether  the  United  Kingdom  competent  authorities  ensure  the  effective 
enforcement  within  their  territory  of  the  rules  referred  to  in  point  (a), 
among  others,  by  means  of  inspections  and  audits  of  marketing 
authorisation holders, manufacturing authorisation holders and wholesale 
distributors  located  in  their  territories,  and  on-the-spot  checks  at  their 
premises regarding the exercise of the regulatory functions referred to in 
point (a).  

2.  Where  the  Commission  finds  that  the  level  of  protection  of  public  health 
ensured  by  the  United  Kingdom  through  rules  governing  the  production, 
distribution and use of medicinal products as well as the effective enforcement 
of those rulesis no longer  essentially equivalent to that guaranteed within the 
Union,  or  where  sufficient  information  is  not  available  to  the  Commission  to 
establish whether an essentially equivalent level of protection of public health 
is  ensured  by  the  United  Kingdom,  the  Commission  shall  inform  the  United 
Kingdom  through  a  written  notification  of  that  finding  and  of  the  detailed 
reasons therefor. 

For  a period of 6 months following that  written  notification, the Commission 
shall  enter  into  consultations  with  the  United  Kingdom  with  a  view  to 
remedying the situation giving rise to the written notification made pursuant to 
the first subparagraph. In duly justified cases, the Commission may extend that 
period by 3 months. 

3. 

If  the  situation  giving  rise  to  the  written  notification  made  pursuant  to 
paragraph 2, first subparagraph, is not remedied within the time-limit referred 
to in paragraph 2, second subparagraph, the Commission shall be empowered 

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to  adopt  a  delegated  act  specifying  the  provisions  among  those  referred  to  in 
paragraph 1 whose application shall be suspended.  

4.  Where a delegated act pursuant to paragraph 3 has been adopted, the provisions 
referred to in the first sentence of paragraph 1 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. 

5.  Where the situation giving rise to the adoption of the delegated act pursuant to 
paragraph  3  has  been  remedied,  the  Commission  shall  adopt  a  delegated  act 
specifying the provisions in relation to which the delegated act pursuant to in 
paragraph 3 has been adopted 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. 

6.  Article 121a (3) – (6) shall apply to the power to adopt delegated acts referred 

to in paragraphs 3 and 5.  

(10) 

the following Article 126c is inserted:  

Article 126c 

“1.  By  way  of  derogation  from  Article  126a,  until  31  December  2024,  in  the 
absence  of  a  marketing  authorisation  or  of  a  pending  application  for  a 
marketing authorisation the competent authorities of Cyprus and Malta may for 
justified public health reasons authorise the placing on their national market of 
a  medicinal  product  authorised  in  parts  of  the  United  Kingdom  other  than 
Northern Ireland.  

The competent authorities of Cyprus and Malta may also maintain in force or, 
until 31 December 2024, extend marketing authorisations granted before [date 
of entry into force of this Amending Directive] pursuant to Article 126a which 
authorise the placing on their national market of a medicinal product authorised 
in parts of the United Kingdom other than Northern Ireland. 

Authorisations  granted,  extended  or  maintained  in  force  pursuant  to  the  first 
and second subparagraph shall not be valid after 31 December 2026. 

2. 

By way of derogation from Article 8(2), the competent authorities of Malta and 
Cyprus may grant marketing authorisations as referred to in the paragraph 1 to 
marketing  authorisation  holders  established  in  parts  of  the  United  Kingdom 
other than Northern Ireland. 

3.  Where  the  competent  authorities  of  Cyprus  or  Malta  grant  or  extend  a 
marketing  authorisation  as  referred  to  in  paragraph  1,  they  shall  ensure 
compliance with the requirements of Directive 2001/83/EC and this Directive.  

4. 

Before  granting  a  marketing  authorisation  pursuant  to  paragraph  1,  the 
competent authorities of Cyprus or Malta: 

(a) 

shall  notify  the  marketing  authorisation  holder  in  parts  of  the  United 
Kingdom  other  than  Northern  Ireland  of  the  proposal  to  grant  a 
marketing authorisation or to extend a marketing authorisation under this 
Article in respect of the medicinal product concerned; 

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(b)  may  request  the  competent  authority  in  the  United  Kingdom  to  submit 
the  relevant  information  regarding  the  marketing  authorisation  of  the 
medicinal product concerned.”;  

(11) 

the following Articles 127c and 127d are inserted: 

“Article 127c 

The  derogations  set  out  in  Articles  8(2a),  8(2b),  18a,  20  second  paragraph,  40(1a), 
40(3a),  48(3),  104(3a)  and  126c  shall  not  affect  the  obligations  of  the  marketing 
authorisation  holder  to  ensure  the  quality,  safety  and  efficacy  of  the  medicinal 
product  placed  on  the  markets  of  Cyprus,  Ireland,  Malta  or  Northern  Ireland  laid 
down in Directive 2001/83/EC. 

Article 127d 

1. 

2. 

By  [30  days  after  the  entry  into  force  of  this  Directive],  the  competent 
authorities  of  Cyprus,  Ireland,  Malta  and  the  United  Kingdom  in  respect  of 
Northern Ireland shall establish, notify to the Commission and publish on their 
website  a  list  of  medicinal  products  to  which  they  have  applied  or  intend  to 
apply or the derogations as set out in this Directive.  

The competent authorities of Cyprus, Ireland, Malta, and the United Kingdom 
in respect of Northern Ireland shall ensure that the list referred to in paragraph 
1 is  updated and managed in  an independent  manner, at  least  on a 6-monthly 
basis.” 

Article 3 

1. 

Member  States  shall  adopt  and  publish,  by  [30  June  2022]  at  the  latest,  the  laws, 
regulations  and  administrative  provisions  necessary  to  comply  with  this  Directive. 
They shall forthwith communicate to the Commission the text of those provisions. 

They shall apply those provisions from 1 January 2022. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This  Directive shall enter into  force on the  third  day  following that of its publication in  the 
Official Journal of the European Union. 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, 

Article 5 

For the European Parliament 
The President 

For the Council 
The President 

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