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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

article  79

CELEX:  02001L0083-20250101

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.