In order to obtain the distribution authorization, applicants must fulfil the following minimum requirements:
they must have suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products;
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;
they must undertake to fulfil the obligations incumbent on them under the terms of Article 80.
Textual Amendments
F1 Substituted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).