Directive 2001/83/EC of the European Parliament and of the CouncilDangos y teitl llawn

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 79U.K.

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.