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

1. 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.

1. 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.

1. 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.

1. 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:

1. 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:

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

Done at Brussels, 12 April 2022.

For the European Parliament

The President

R. Metsola

For the Council

The President

C. Beaune