Directive 1992/25 - Wholesale distribution of medicinal products for human use - Main contents

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

Official Journal L 113 , 30/04/1992 P. 0001 - 0004

Finnish special edition: Chapter 13 Volume 22 P. 0029

Swedish special edition: Chapter 13 Volume 22 P. 0029

COUNCIL DIRECTIVE 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission(1) ,

in cooperation with the European Parliament(2) ,

Having regard to the opinion of the Economic and Social Committee(3) ,

Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

Whereas the wholesale distribution of medicinal products is at present subject to different provisions in the various Member States; whereas many operations involving the wholesale distribution of medicinal products for human use may cover several Member States simultaneously;

Whereas it is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the Community through to supply to the public, so as to guarantee that such products are stored, transported and handled in suitable conditions; whereas the requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products;

Whereas any person involved in the wholesale distribution of medicinal products should be in possession of a special authorization; whereas pharmacists and persons authorized to supply medicinal products directly to the public, and who confine themselves to this activity, should be exempt from obtaining this authorization; whereas it is however necessary, in order to control the complete chain of distribution of medicinal products, that pharmacists and persons authorized to supply medicinal products to the public keep records showing transactions in products received;

Whereas authorization must be subject to certain essential conditions and it is the responsibility of the Member State concerned to ensure that such conditions are met; whereas each Member State must recognize authorizations granted by other Member States;

Whereas certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorized to supply medicinal products to the public certain public service obligations; whereas those Member States must be able to continue to impose those obligations on wholesalers established within their territory; whereas they must also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those which they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection,

HAS ADOPTED THIS DIRECTIVE:

Article 1

• 1. 

  This Directive covers the wholesale distribution in the Community of medicinal products for human use to which Chapters II to V of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(4) apply.

• 2. 

  For the purposes of this Directive:

• - 

  wholesale distribution of medicinal products shall mean all activities consisting of procuring, holding, supplying or exporting medicinal products, apart...

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