1. Member States shall take all appropriate measures to ensure that the manufacture of the medicinal products within their territory is subject to the holding of an authorization. This manufacturing authorization shall be required nothwithstanding that the medicinal products manufactured are intended for export.
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.
2. The authorization referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.
However, such authorization shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in the Member States to carry out such processes.
3. Authorization referred to in paragraph 1 shall also be required for imports coming from third countries into a Member State; this Title and
Article 118 shall have corresponding application to such imports as they have to manufacture.
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.
4. Member States shall enter the information relating to the authorisation referred to in paragraph 1 of this Article in the Union database referred to in
Article 111(6).