Article 24 — Amendments to Regulation (EC) No 816/2006

Regulation (EC) No 816/2006 is amended as follows: (1) the following article is inserted: Article 18a Union compulsory licence 1. By way of derogation from Article 1, second subparagraph, from Article 2, point (4), and from Article 3, the Commission may grant a compulsory licence applicable to the whole of the Union where the activities of manufacture and sale for export are spread across different Member States and would therefore require compulsory licences for the same product in more than one Member State. 2. Any person may submit an application for a Union compulsory licence referred to in paragraph 1 of this Article. By way of derogation from Article 6(1) and (2), that application shall be submitted to the Commission. The application shall fulfil the requirements laid down in Article 6(3), points (a) to (f), and shall specify the Member States in which the activities of manufacture and sale for export of the product to be covered by the Union compulsory licence are to be carried out. Articles 7, 8, 9 and 12 shall apply mutatis mutandis. 3. The Union compulsory licence referred to in paragraph 1 of this Article shall be subject to the conditions set out in Article 10 and shall specify that it is applicable to the whole of the Union. 4. The Commission shall, by means of an implementing act: (a) grant a Union compulsory licence referred to in paragraph 1; (b) reject an application for a Union compulsory licence submitted pursuant to paragraph 2; (c) modify or terminate the Union compulsory licence granted pursuant to point (a). In cases referred to in the first subparagraph, point (b), of this paragraph, Article 11 shall apply mutatis mutandis. In cases referred to in the first subparagraph, point (c), of this paragraph, Article 5, point (c), and Article 16 shall apply mutatis mutandis. The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 18b(2). On duly justified imperative grounds of urgency relating to the impact of the public health problems to be addressed, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18b(3). ; (2) the following article is inserted: Article 18b Committee procedure 1. The Commission shall be assisted by a committee (the Compulsory Licensing Committee). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. 4. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply. ; (3) the following article is inserted: Article 18c Applicability to and in the United Kingdom in respect of Northern Ireland The procedure for granting a Union compulsory licence under Article 18a, and a Union compulsory licence granted under that Article, shall not apply to and in the United Kingdom in respect of Northern Ireland. The United Kingdom in respect of Northern Ireland shall ensure that the products manufactured under such a licence are not imported into the Union or Northern Ireland in accordance with Article 13, and shall take the necessary actions to that end in accordance with Article 14..