To guarantee optimum conditions for the preservation, transport and handling of medicinal products.

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human consumption.

The Directive sets out to guarantee control of the entire distribution chain, from leaving the factory to being sold to the public.

This control concerns in particular wholesalers who, once they have a specific authorization from the State in which they are established, can, in application of the principle of mutual recognition, exercise their activity throughout the Community.

Dispensing chemists and persons expressly authorized to supply medicinal products to the public are exempted from the authorization on condition that they do not exercise any wholesale activity in a principal or secondary role.

The granting of this authorization will be subject to compliance with certain essential requirements:

The procedure for granting the authorization will not exceed 90 days from the date of receipt of the application. Any refusal, suspension or withdrawal must be notified to the party in question. The Member States and the Commission will be informed of any withdrawal or suspension. Control and inspection will be effected under the authority of the Member State which granted the authorization.

If need be, the Commission will publish guidelines on good distribution practice and, where appropriate, will consult for this purpose the Pharmaceutical Committee.

4) deadline for implementation of the legislation in the member states

01.01.1993

5) date of entry into force (if different from the above)

6) references

Official Journal L 113, 30.04.1992

8) commission implementing measures

Guidelines on good distribution practice for medicinal products for human use (Official Journal C 63, 01.03.1994).

On 29 January 1994, in accordance with Article 10 of Directive 92/25/EEC, the Commission adopted guidelines on good distribution practice for medicinal products for human use setting out the rules to be followed by wholesalers to ensure that they do not impair the quality of such products in the course of their distribution and that they can participate effectively in identifying and recalling defective or counterfeit products introduced into the distribution network.