Article 3Specific 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.
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:
(b)keep records as regards the information referred to in Article 80, first paragraph, point (e), last indent, of Directive 2001/83/EC.
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.