Holders of the distribution authorization must fulfil the following minimum requirements:
(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;
(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);
(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;
(ca) they 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);
(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;
(e) they 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;
- (f) they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years;
(g) they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in
Article 84;
(h) they must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities;
(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.
For 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.