EN   EN 
 
 
 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)   EN 1  EN 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 Irela nd  
must be covered by  a valid marketing authorisation issued by the Commission  (EU-
wide authorisations)  or the U nited 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 ab ility 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 
generic s and over-the-counter medicines). There are two possible nati onal 
authorisation routes:  purely UK national authorisations (“N orthern Ireland -only 
authorisations”) , which concern medicines that are made available in N orthern 
Ireland  only, and  UK national authorisations issued under Union law procedures 
involving at least another Member State ( Mutual Recognition or Decentralised 
Procedure s2). 
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 
undisrupte d supply of medicines to N orthern Ireland , Cyprus , Ireland  and Malta .4  
Despite the transition period, i t still proves very difficult for certain  operators 
currently based in parts of th e United Kingdom other than Northern Ireland  to adapt 
and move relevant regulatory compliance functions (namely, the marketing 
authorisation h older,  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, N orthern 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) w holesale distributors in Northern Ireland, Cyprus, Ireland and Malta to 
place medicin al products impor ted 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 N orthern 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.  EN 2  EN too high adjustment costs relative to the small size of the N orthern Irish market and 
the complex logistics involved, for which no viable alternative logistical hubs in 
Northern Irel and have been identified.   
By the same token, m ost industry players currently based in parts of the United 
Kingdom other than Northern Ireland  are n ot 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 fro m or through 
parts of the United Kingdom other than Northern Ireland . Medi cines 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 M alta. 
This proposal allows exceptionally that:  
– 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 patien ts 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 Uni on. 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 r efused 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 applicatio n 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 medic inal product which is already being examined 
or has already been authorised in a Member State, the proposal  provides that the EN 3  EN 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 mutu al 
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 
market s 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 th e 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 n ot 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 act s 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 . 
                                                 
5 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).  
6 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 o n 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).  EN 4  EN 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 circu mstances.  
This proposal aims to provide derogations for medicinal products distributed to 
Northern Ireland , Cyprus, Ireland and Malta.  
• Proportionality  
The proposal covers the exemptions for regulator y functions that ha d not been 
transferred by industry to the EU or Northern Ireland before  the end of the transition 
period provided for in the Withdrawal Agreement. Th is proposal is not going beyond 
what is absolutely necessary to ensure continu ed supply  of medicinal products (for 
human  use). 
The proposal is restricted to medicin al products  made  exclusively  available in 
Northern Ireland and the small ma rkets of the Union that are dependent o n 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. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
• 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  suppl ies. 
• Impact  assessment  
The p roposal is exempted from the impact assessment due to the urgency of the 
situation , to ensure p ublic health through  the continued supply of  medicin al products 
in Northern Ireland and the small markets of the U nion that are depend ent on the U K 
for their supplies . 
• Regulatory  fitness  and simplification  
By waiving certain regulatory requirements  for the importation of me dicinal 
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.  EN 5  EN 5. 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 fo r this proposal.  EN 6  EN 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 U NION,  
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,  
Havi ng 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 e ntered into force on 1 February 2020. The 
transition period referred to in Article 126 of the Withdrawal Agreement, during which 
Union law continue d to apply to and in the United Kingdom in accordance with 
Article 127 of the Withdrawal Agreement (the ‘transition period’), end ed on 31 
December 2020.  On 25 January 2021 , the Commission issued a Notice3 on the 
application of the Union’s pharmaceutical acq uis 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/North ern 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 OJ L 29, 31.1.2020, p. 7.  
2 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 ). 
3 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).  EN 7  EN (3) Directive s 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 . 
(4) Cyprus, Ireland, Malta and Northern Ireland have historically relied on supply of 
medicinal products fr om 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 pub lic 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. 
(5) 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 mark ets 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. 
(6) Regulation (EC) No 726/2004  of the Europea n Parliament and of the Council6 lays 
down Union procedures for the authorisation of medicinal products . Upon 
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 authorisatio n, 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 i n 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 
                                                 
4 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 con duct of clinical trials on medicinal products for 
human use (OJ L 121, 1.5.2001, p. 34).  
5 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, 2 8.11.2001, p. 67).  
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 Eur opean Medicines Agency  (OJ L 136, 30.4.2004, p. 1 ). EN 8  EN Commission takes a decision to grant or refuse the authorisation to market that 
medicinal product.  
(7) In accord ance 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 holder s 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, Ma lta and Northern Ireland, it is necessary to 
allow the national competent authorities of Cyprus, Ireland, Mal ta and Northern 
Ireland  to grant market ing authorisations in the context of the mutual recognition and 
decentralise d procedures  to marketing authorisation holders established  in parts of the 
United Kingdom other than Northern Ireland.  
(8) 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 Kin gdom 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, th e requirement  to comply with this  obligation may hamper the continu ous 
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 recogni tion or decentralised procedure s 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, in cluding  the 
requirements on the quality, safety and efficacy of medicin al products . 
(9) In accord ance 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 t hrough 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 ou t 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 medi cines 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 Unio n 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 harmonis ing the implementation of  that provision with regard EN 9  EN to medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland from 
parts of the United Kingdom other than Northern Ireland.  
(10) It follows f rom Article 40(3) of Directive 2001/83/EC,  read in conjunction with the 
Protocol , that import ers 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 th at requirement under 
certai n 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  
require d 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 auth orisation holder  to have 
at its disposal a qualified person is established in and operat ing 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 quali fied per son 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 t o 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  establish ed in parts of the United 
Kingdom oth er 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 author isation s 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 Malt a shall ensure 
that such authorisations comply with Union law. In order to ensure that the functioning 
of the Union m arket is not undermined i t is necessary to establish the conditions  for 
enhanced supervision  and enforcement  of the rules relevant for the a pplication  of the 
derogations introduced by this Directive . The Commission , should monitor 
developments in parts of the United Kingdom other than Northern Ireland that could EN 10  EN 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 r ules governing the production, distribution and use 
of medicinal products as well as the effective enforcement of those rules is no long er 
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, t he 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, t hat list should 
contain the same information as included in the package leaflet or summary of product 
characteristics of the medicinal products concerned.  
(16) Directive s 2001/ 20/EC and Directive 2001/ 83/EC should therefore be amended 
accordingly . 
(17) In order  to ensure legal continuity for operators active in th e pharmaceutical  sector  and 
to guarantee  the continu ous 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, Cypru s 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) 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 compl iance with  the requirements set out in paragraph 3 , point  (b);  
(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 North ern Ireland, are only made available to clinical trial participants 
in Northern Ireland .” 
Article 2  
Directive 2001/83 /EC is amended as follows : 
(1) the following Article 5a is inserted:  
“Article 5a  EN 11  EN 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 Artic le 3(1) and (2) of Regulation  (EC) No  726/2004 provided that the 
following conditions are fulfilled : 
(a) 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;  
(b) 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 Regu lation (EC)  No 726/2004, or when such 
marketing authorisation has been refused in accordance with that Article .”; 
(2) in Article 8(2 ), the following paragraph s 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 authorisation s 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 l aid 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 m arketing authorisations granted or extended  by the competent authorities 
of Cyprus , Ireland  or Malta  in accordance with the first  and second  
subparagraph  shall e xpire 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 author ised in a Member State, 
the application regarding the United Kingdom in respect of Northern Ireland EN 12  EN shall not have to be submitted in accordance with Articles 28 to 39 , provided 
that all of  the following conditions are fulfilled:  
(a) 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 ; 
(b) the medicinal product s 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 . 
2. The marketing authorisation holder of a medicinal product for which a 
marketing authorisation has already been granted for the United Kingdom in 
respect of North ern 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.” 
(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) each batch of the medicinal pro ducts 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 ;  
(b) 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 b y 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 Ir eland  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 EN 13  EN 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) the medicinal products have undergone quality control testing either in 
the Union, as provided f or in Artic le 51(3) , or in parts of the United 
Kingdom other than Northern Ireland  in compliance with Artic le 20 , 
point (b);  
(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);  
(c) 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 impor ted, or, 
if imported into Northern Ireland, are only made available to patients or 
end-consumers in Northern Ireland ; 
(e) the medicinal product s 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 N orthern 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 control s  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 King dom 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 whe re 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:  EN 14  EN “By way of derogation from  the second subparagraph, w here the marketing 
authorisation is granted by the competent authority of United Kin gdom 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 whe re the marketing 
authorisa tion 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 p arts 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 
manu facturing 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 t he United Kingdo m 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 funct ions referred to in 
point (a).  
2. Where the Commission finds that the level of protection of public health  
ensured by the Unite d Kingdom  through r ules 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 deta iled 
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 notificat ion made pursuant to 
the first sub paragraph . 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 EN 15  EN 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 bee n 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 a doption 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 Malt a may for 
justified public health reasons  authorise the placing on the ir 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 Am ending 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 t o 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 author isation 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 authorisati on 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 marke ting authorisation under this 
Article in respect of the medicinal product concerned ; EN 16  EN (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 Article s 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 t he marketing 
authorisation holder to ensur e 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. By [ 30 days after the entry into fo rce of this Directive ], the competent 
authorit ies 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.  
2. 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, 
regulati ons 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, th ey 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 tex t of the main provisions 
of national law which they adopt in the field covered by this Directive.  
Article 4 
This Directiv e shall enter into force on the  third day following that of its publication in the 
Official Journal of the European Union . 
Article 5 
This Directive is addressed to the Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President  