Activities of Pascal CANFIN related to 2023/0064(COD)
Reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland
Amendments (5)
Amendment 1 #
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(c) thereof,
Amendment 3 #
Proposal for a regulation
Recital 9
Recital 9
(9) In respect of new and innovative products, the competent authorities of the United Kingdom should be able to authorise the placing of these products on the market in Northern Ireland once certain conditions are fulfilled, including that the authorisation is granted in accordance with the law of the United Kingdom and that the products are placed on the market in Northern Ireland under the terms of the authorisation granted by the competent authorities of the United Kingdom, that these products comply with certain labelling requirements, and lastly that the written guarantees have been provided by the United Kingdom to the European Commission.
Amendment 7 #
Proposal for a regulation
Article 3 – paragraph 5 – point b
Article 3 – paragraph 5 – point b
(b) keep records in accordance with the last indent of Article 80, point (e), of Directive 2001/83/EC.
Amendment 8 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
It shall apply from 1 January 2025, provided that the United Kingdom has provided the written guarantees referred to in Article 8 and that the Commission has published prior to that date the Notice referred to in the fifth subparagraph.
Amendment 9 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
Within one month after reception of those written guarantees, the Commission shall provide a report to the European Parliament and the Council of its assessment thereof.