Directive 2001/83/EC of the European Parliament and of the… Article 79
Article 79
In order to obtain the distribution authorization, applicants must fulfil the following minimum requirements:
(a) they must have suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products;
(b) they must have staff, and in particular, a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned;
(c) they must undertake to fulfil the obligations incumbent on them under the terms of Article 80.
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 79 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)
