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Directive 2001/83/EC of the European Parliament and of the… Article 80

Article 80

Holders of the distribution authorization must fulfil the following minimum requirements: (a) they must make the premises, installations and equipment referred to in Article 79(a) accessible at all times to the persons responsible for inspecting them; (b) they must obtain their supplies of medicinal products only from persons who are themselves in possession of the distribution authorization or who are exempt from obtaining such authorization under the terms of Article 77(3); (c) they must supply medicinal products only to persons who are themselves in possession of the distribution authorization or who are authorized or entitled to supply medicinal products to the public in the Member State concerned; (d) they must have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or marketing authorization holder for the medicinal product concerned; (e) they must keep records either in the form of purchase/sales invoices, or on computer, or in any other form, giving for any transaction in medicinal products received or dispatched at least the following information: - date, - name of the medicinal product, - quantity received or supplied, - name and address of the supplier or consignee, as appropriate; (f) they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years; (g) they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84.

Read the full instrument → · Read this in context: TITLE VII — WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS →

Other provisions in TITLE VII — WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 80 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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