Changes from plenary report to adopted text

Added(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.

Added4. 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 Chapter III, Sections 3 and 4, 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.

Added5. With regard to quality control testing referred to in Article 8 carried out in parts of the United Kingdom other than Northern Ireland regarding medicinal products included in the list referred to in Article 211(9) other than those authorised by the Commission, the competent authorities of the United Kingdom in respect of Northern Ireland may consider that there is a justifiable case within the meaning of Article 8, point (b), without carrying out a case-by-case assessment provided that:

Added(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 153;

Added(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;

Added(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.

Added6. By way of derogation from Article 142(1), the competent authorities of the United Kingdom in respect of Northern Ireland shall allow medicinal products to be imported from parts of the United Kingdom other than Northern Ireland by a wholesale distribution authorisation holders as referred to in Article 163(1) that are not in possession of a relevant manufacturing authorisation provided that all of the following conditions are fulfilled:

Added(a) the medicinal products have undergone quality control testing either in the Union, as provided for in Article 153(3), or in parts of the United Kingdom other than Northern Ireland in compliance with Article 8, point (b);

Added(b) the medicinal products have been subject to batch release by a qualified person in the Union in accordance with Article 153(1) or, for medicinal products authorised by 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 153(1);

Added(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;

Added(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;

Added(e) the medicinal products bear the safety features referred to in Article 67.

Added7. For batches of medicinal products that are exported to parts of the United Kingdom other than Northern Ireland from a Member State and subsequently imported into Northern Ireland, the controls upon importation referred to in Article 153(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 153(1), third subparagraph.

Added8. 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 Article 151(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.

Added9. By way of derogation from the Article 99(5), where the marketing authorisation is granted by the competent authority of United Kingdom in respect of Northern Ireland, the qualified person referred to in Article 99(4), point (a), may reside and operate in parts of the United Kingdom other than Northern Ireland. This paragraph 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.

Added10. The competent authorities of the United Kingdom in respect of Northern Ireland shall 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 Article and shall ensure that the list is updated and managed in an independent manner, at least on a six-monthly basis.

AddedArticle 210 Regulatory functions carried out in the United Kingdom

Added1. 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 99(4), Article 151(3), Article 211, paragraphs 1, 2, 5 and 6, Article 209, paragraphs 6 and 7, that are carried out in parts of the United Kingdom other than Northern Ireland taking into account, in particular, the following elements:

Added(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;

Added(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).

Added2. 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.

AddedFor 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.

Added3. 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 amending or supplementing the provisions among those referred to in paragraph 1 whose application shall be suspended.

Added4. 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.

Added5. 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.

AddedArticle 211 Provisions relevant to Cyprus, Ireland and Malta and applicable until 31 December 2024

Added1. By way of derogation from Article 56(4), marketing authorisations may be granted in accordance with the mutual recognition or the decentralised procedure laid down in Chapter III, Sections 3 and 4, to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

AddedUntil 31 December 2024, the competent authorities of Cyprus, Ireland and Malta marketing authorisations already granted prior to 20 April 2022 may be extended to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

AddedThe marketing authorisations granted or extended by the competent authorities of Cyprus, Ireland or Malta in accordance with the first and second subparagraphs shall cease to be valid at the latest on 31 December 2026.

Added2. With regard to quality control testing referred to in Article 8 carried out in parts of the United Kingdom other than Northern Ireland regarding medicinal products included in the list referred to in paragraph 9, other than those authorised by the Commission, 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 Article 8, point (b), without carrying out a case-by-case assessment provided that:

Added(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 153(1);

Added(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;

Added(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.

Added3. By way of derogation from Article 142(1), 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 wholesale distribution authorisation holders as referred to in Article 163(1) that are not in possession of a relevant manufacturing authorisation provided that all of the following conditions are fulfilled:

Added(a) the medicinal products have undergone quality control testing either in the Union, as provided for in Article 153(3), or in parts of the United Kingdom other than Northern Ireland in compliance with Article 8, point (b);

Added(b) the medicinal products have been subject to batch release by a qualified person in the Union in accordance with Article 153(1) or, for medicinal products authorised by the competent authorities 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 153(1);

Added(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;

Added(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;

Added(e) the medicinal products bear the safety features referred to in Article 67.

AddedArticle 166(1), point (b), shall not apply to imports that fulfil the conditions laid down in the first subparagraph.

Added4. For batches of medicinal products that are exported to parts of the United Kingdom other than Northern Ireland from a Member State and subsequently imported until 31 December 2024 into Cyprus, Ireland or Malta, the controls upon importation referred to Article 153(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 153(1), third subparagraph.

Added5. By way of derogation from Article 205(1) 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.

AddedThe 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 205(1) before 20 April 2022 and that authorise the placing on their national market of a medicinal product authorised in parts of the United Kingdom other than Northern Ireland.

AddedAuthorisations that are granted, extended or maintained in force pursuant to the first or second subparagraphs shall not be valid after 31 December 2026.

Added6. By way of derogation from Article 56(4), the competent authorities of Malta and Cyprus may grant marketing authorisations as referred to in paragraph 5 to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland.

Added7. Where the competent authorities of Cyprus or Malta grant or extend a marketing authorisation as referred to in paragraph 5, they shall ensure compliance with the requirements of this Directive.

Added8. Before granting a marketing authorisation pursuant to paragraph 5, the competent authorities of Cyprus or Malta:

Added(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 paragraphs 5 to 8 in respect of the medicinal product concerned;

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

Added9. The competent authorities of Cyprus, Ireland, Malta shall 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 Article and shall ensure that the list is updated and managed in an independent manner, at least on a six-monthly basis.

AddedArticle 212 Derogations for medicinal products placed on the markets of Cyprus, Ireland, Malta or Northern Ireland

AddedThe derogations set out in Article 211, paragraphs 1 and 6, Article 8, Article 209, paragraphs 6 and 7, Article 153 (3), Article 99(4) and Article 211(5) 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.

AddedChapter XVIII Final provisions

AddedArticle 213 Amendment to the Annexes

AddedThe Commission is empowered to adopt delegated acts in accordance with Article 215 amending Annexes I to VI in order to adapt them to scientific and technical progress and amend Article 22 with regard to the ERA requirements set out in paragraphs 2, 3, 4 and 6 of that Article.

AddedArticle 214 Standing Committee on Medicinal Products for Human Use

Added1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Added2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Added3. Where the opinion of the Committee is to be obtained by written procedure and reference is made to this paragraph, that procedure shall be terminated without result only when, within the time limit for delivery of the opinion, the chair of the Committee so decides.

Added4. The rules of procedure, lists of participating entities of its meetings, agendas for its meetings and records of its meetings, accompanied by decisions taken, and, where applicable, details of votes and explanations of votes, including minority opinions, of the Standing Committee on Medicinal Products shall be made publicly available. [Am. 324]