Legal provisions of COM(2021)997 - Amendment of Directives as regards derogations from obligations concerning medicinal products made available in the UK (in respect of Northern Ireland), Cyprus, Ireland, Malta

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dossier COM(2021)997 - Amendment of Directives as regards derogations from obligations concerning medicinal products made available in the UK (in ...
document COM(2021)997 EN
date April 12, 2022


Article 1

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

‘By way of derogation from the first subparagraph, 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 investigational medicinal products to be imported from parts of the United Kingdom other than Northern Ireland without such an authorisation provided that all of the following conditions are fulfilled:

(a)the investigational 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);

(b)the investigational medicinal products are only made available to subjects in the Member State into which those investigational medicinal products are imported, or, if imported into Northern Ireland, are only made available to subjects in Northern Ireland.’.

Article 2

Directive 2001/83/EC is amended as follows:

(1)the following Article is inserted:

‘Article 5a

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 all of 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 six months. Notwithstanding the specified validity, the temporary authorisation shall cease to be valid if the medicinal product concerned has been granted a marketing authorisation in accordance with Article 10 of Regulation (EC) No 726/2004, or if such marketing authorisation has been refused in accordance with that Article.’;

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

‘2a.   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 to applicants 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 4 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 20 April 2022 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 cease to be valid at the latest on 31 December 2026.’;

(3)the following Article 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 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 period of validity of that marketing authorisation;

(b)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.

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 Northern Ireland in accordance with Articles 28 to 39 before 20 April 2022 shall be allowed to withdraw the marketing authorisation for the United Kingdom in respect of Northern Ireland from the mutual recognition or the 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 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 that are 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 by a qualified person who resides and operates 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 who resides and operates in the Union on 20 April 2022.’;

(5)Article 40 is amended as follows:

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

(a)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, first paragraph, 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 quality standards that are equivalent to those laid down in Article 51(1);

(c)the marketing authorisation for the medicinal product concerned has been granted 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 imports that fulfil the conditions laid down in the first subparagraph of this paragraph.’;

(b)the following paragraph 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, provided that 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 that they are accompanied by the control reports referred to in Article 51(1), third subparagraph.’;

(6)in Article 48, the following paragraph is added:

‘3.   Where the manufacturing 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 and operate in 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 who resides and operates in the Union on 20 April 2022.’;

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

‘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 and operate in 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 who resides and operates in the Union on 20 April 2022.’;

(8)the following Article 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 Article 8(2a) and (2b), Article 20, second paragraph, Article 40(1a) and (3a), Article 48(3), Article 104(3) and Article 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 persons and their obligations, quality control testing, batch release and pharmacovigilance as laid down in United Kingdom law;

(b)whether the competent authorities of the United Kingdom ensure the effective enforcement within their territory of the rules referred to in point (a), by means of, inter alia, 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 rules is no longer essentially equivalent to that guaranteed within the Union, or where sufficient information is not available to the Commission to enable it 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 six months following the written notification made pursuant to the first subparagraph, the Commission shall enter into consultations with the United Kingdom with a view to remedying the situation giving rise to that written notification. In justified cases, the Commission may extend that period by three months.

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 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 introductory 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 those suspended provisions 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.’;

(9)Article 121a is amended as follows:

(a)in paragraph 2, the following subparagraph is added:

‘The power to adopt delegated acts referred to in Article 111c(3) and (5) shall be conferred on the Commission for an indeterminate period of time from 20 April 2022.’;

(b)paragraph 3 is replaced by the following:

‘3.   The delegation of power referred to in Article 14(1), Articles 22b, 23b, 46a, 47, 52b, 54a, Article 111c(3) and (5), and Article 120 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.’;

(c)paragraph 6 is replaced by the following:

‘6.   A delegated act adopted pursuant to Article 14(1), Articles 22b, 23b, 46a, 47, 52b, 54a, Article 111c(3) or (5), or Article 120 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

(10)the following Article 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 authorise for justified public health reasons 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 that were granted pursuant to Article 126a before 20 April 2022 which authorise the placing on their national market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland.

Authorisations that are granted, extended or maintained in force pursuant to the first or 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 paragraph 1 of this Article 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 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;

(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 are inserted:

‘Article 127c

The derogations set out in Article 8(2a) and(2b), Article 18a, Article 20, second paragraph, Article 40(1a) and (3a), Article 48(3), Article 104(3a) and Article 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 this Directive.

Article 127d

1. By 20 May 2022, 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 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 six-monthly basis.’.

Article 3

1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive within a period of four months as from the date of its entry into force. They shall immediately inform the Commission thereof.

They shall apply those measures from 1 January 2022.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

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.

Article 4

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

Article 5

This Directive is addressed to the Member States.