Activities of Beatrice COVASSI related to 2023/0064(COD)
Shadow 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 (4)
Amendment 2 #
Proposal for a regulation
Recital 8
Recital 8
The specific rules should include the prohibition to display the safety features referred to in Directive 2001/83/EC on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products for human use intended to be placed on the market in Northern Ireland, with the exception of the anti- tampering device measures set out in Directive 2011/62/EU which should remain in place. The specific rules should also include and the prohibition to place on the market in Northern Ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with Regulation (EC) No 726/2004. Furthermore, the specific rules should include certain labelling requirements for medicinal products for human use intended to be placed on the market in Northern Ireland. As a consequence, Commission Delegated Regulation (EU) 2016/1616 should not apply to medicinal products for human use intended to be placed on the market in Northern Ireland.
Amendment 4 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
The safety features referred to in Article 54, point (o) with the exception of the anti-tampering device measures, of Directive 2001/83/EC shall not appear on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products referred to in Article 1(1) of this Regulation
Amendment 5 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
Where a medicinal product referred to in Article 1(1) of this Regulation bears the safety feature referred to in Article 54, point (o) with the exception of the anti- tampering device measures, of Directive 2001/83/EC, it shall be fully removed or covered.
Amendment 6 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
The qualified person referred to in Article 48 of Directive 2001/83/EC shall, in the case of medicinal products referred to in Article 1(1) of this Regulation, ensure that the safety features referred to in Article 54, point (o) with the exception of the anti- tampering device measures, of Directive 2001/83/EC have not been affixed on the packaging of the medicinal product.