TITLE VIIWHOLESALE DISTRIBUTION AND BROKERING OF MEDICINAL PRODUCTS

Article 79

In order to obtain the distribution authorization, applicants must fulfil the following minimum requirements:

  1. (a)

    they must have suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products;

  2. (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;

  3. (c)

    they must undertake to fulfil the obligations incumbent on them under the terms of Article 80.