Explore European Union Legislation by Asking a Legal Question
assisted-checkbox
filter-instruction-1
positive-filters
negative-filters
act-filter tabs-all
parameters-title
query
assisted-checkbox: ✅
result-title
total 3
Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC (Text with EEA relevance) article 3 CELEX: 32023R1182 Specific rules for medicinal products as referred to in Article 1(1)
1. The competent authorities of the United Kingdom in respect of Northern Ireland may allow medicinal products as referred to in Article 1(1) of this Regulation to be imported into Northern Ireland from other parts of the United Kingdom by holders of a wholesale distribution authorisation that are not in possession of a relevant manufacturing authorisation, provided that the conditions laid down in Article 40(1a), first subparagraph, points (a) to (d), of Directive 2001/83/EC are fulfilled. 2. The safety features referred to in Article 54, point (o), 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 as referred to in Article 1(1) of this Regulation. 3. Where a medicinal product as referred to in Article 1(1) of this Regulation bears the safety features referred to in Article 54, point (o), of Directive 2001/83/EC, those features shall be fully removed or covered. |
Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC (Text with EEA relevance) article 3 CELEX: 32023R1182 4. The qualified person referred to in Article 48 of Directive 2001/83/EC shall, in the case of a medicinal product as referred to in Article 1(1) of this Regulation, ensure that the safety features referred to in Article 54, point (o), of that Directive have not been affixed on the packaging of the medicinal product. 5. Holders of a wholesale distribution authorisation shall not be required to: (a) verify medicinal products as referred to in Article 1(1) of this Regulation in accordance with Article 80, first paragraph, point (ca), of Directive 2001/83/EC; (b) keep records as regards the information referred to in Article 80, first paragraph, point (e), last indent, of Directive 2001/83/EC. |
Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC (Text with EEA relevance) article 3 CELEX: 32023R1182 6. For all supplies of medicinal products as referred to in Article 1(1) of this Regulation to a person authorised or entitled to supply medicinal products to the public, as referred to in Article 82 of Directive 2001/83/EC, as regards the United Kingdom in respect of Northern Ireland, the authorised wholesaler shall not be required to enclose a document that makes it possible to ascertain the batch number of the medicinal products in accordance with Article 82, first paragraph, last indent, of that Directive. |