Member States shall ensure that the time taken for the procedure for examining the application for the distribution authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application.

The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied.

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.

Holders of the distribution authorization must fulfil the following minimum requirements:

1. (a)

   they must make the premises, installations and equipment referred to in Article 79(a) accessible at all times to the persons responsible for inspecting them;

2. (b)

   they must obtain their supplies of medicinal products only from persons who are themselves in possession of the distribution authorization or who are exempt from obtaining such authorization under the terms of Article 77(3);

3. (c)

   they must supply medicinal products only to persons who are themselves in possession of the distribution authorization or who are authorized or entitled to supply medicinal products to the public in the Member State concerned;

4. (ca)

   F2they must verify that the medicinal products received are not falsified by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts referred to in Article 54a(2);

5. (d)

   they must have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or marketing authorization holder for the medicinal product concerned;

6. (e)

   F4they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or brokered at least the following information:

   • date,

   • name of the medicinal product,

   • quantity received, supplied or brokered,

   • name and address of the supplier or consignee, as appropriate,

   • batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54;

7. (f)

   they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years;

8. (g)

   they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84F4;

9. (h)

   F2they must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities;

10. (i)

    they must immediately inform the competent authority and, where applicable, the marketing authorisation holder, of medicinal products they receive or are offered which they identify as falsified or suspect to be falsified.

F2For the purposes of point (b), where the medicinal product is obtained from another wholesale distributor, wholesale distribution authorisation holders must verify compliance with the principles and guidelines of good distribution practices by the supplying wholesale distributor. This includes verifying whether the supplying wholesale distributor holds a wholesale distribution authorisation.

Where the medicinal product is obtained from the manufacturer or importer, wholesale distribution authorisation holders must verify that the manufacturer or importer holds a manufacturing authorisation.

Where the medicinal product is obtained through brokering, the wholesale distribution authorisation holders must verify that the broker involved fulfils the requirements set out in this Directive.

With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities.

The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.

For all supplies of medicinal products to a person authorized or entitled to supply medicinal products to the public in the Member State concerned, the authorized wholesaler must enclose a document that makes it possible to ascertain:

• the date,

• F1the name and pharmaceutical form of the medicinal product,

• the quantity supplied,

• the name and address of the supplier and consignorF4,

• F2batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54.

Member States shall take all appropriate measures to ensure that persons authorized or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product.

The provisions of this Title shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of:

• narcotic or psychotropic substances within their territory,

• medicinal products derived from blood,

• immunological medicinal products,

• radiopharmaceuticals.

The Commission shall publish guidelines on good distribution practice. To this end, it shall consult the Committee for Medicinal Products for Human Use and the Pharmaceutical Committee established by Council Decision 75/320/EEC29.

This Title shall apply to homeopathic medicinal products.

In the case of wholesale distribution of medicinal products to third countries, Article 76 and point (c) of Article 80 shall not apply. Moreover, points (b) and (ca) of Article 80 shall not apply where a product is directly received from a third country but not imported. The requirements set out in Article 82 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.