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Commission Delegated Regulation (EU) 2016/161Show full title
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)
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Article 31Establishment of the repositories system
1.The repositories system where the information on the safety features shall be contained, pursuant to Article 54a(2)(e) of Directive 2001/83/EC, shall be set up and managed by a non-profit legal entity or non-profit legal entities established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features.
2.In setting up the repositories system, the legal entity or entities referred to in paragraph 1 shall consult at least wholesalers, persons authorised or entitled to supply medicinal products to the public and relevant national competent authorities.
3.Wholesalers and persons authorised or entitled to supply medicinal products to the public are entitled to participate in the legal entity or entities referred to in paragraph 1, on a voluntary basis, at no cost.
4.The legal entity or entities referred to on paragraph 1 shall not require manufacturers, marketing authorisation holders, wholesalers or persons authorised or entitled to supply medicinal products to the public to be members of a specific organisation or organisations in order to use the repository system.
5.The costs of the repositories system shall be borne by the manufacturers of medicinal products bearing the safety features, in accordance with Article 54a(2)(e) of Directive 2001/83/EC.
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