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Directive 2001/83/EC of the European Parliament and of the CouncilShow full title
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
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- Revised 26/07/20194.19 MB
- Revised 28/01/20191.47 MB
- Revised 16/11/20121.37 MB
- Revised 21/07/20111.88 MB
- Revised 20/01/20111.76 MB
- Revised 05/10/20090.46 MB
- Revised 20/07/20090.45 MB
- Revised 30/12/20080.45 MB
- Revised 21/03/20080.44 MB
- Revised 26/01/20070.44 MB
- Revised 30/04/20040.42 MB
- Revised 01/07/20030.38 MB
- Revised 08/02/20030.31 MB
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Article 77U.K.
1.Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler in medicinal products, stating the place for which it is valid.
2.Where persons authorized or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorization provided for in paragraph 1.
3.Possession of a manufacturing authorization shall include authorization to distribute by wholesale the medicinal products covered by that authorization. Possession of an authorization to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorization and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary.
4.At the request of the Commission or any Member State, Member States shall supply all appropriate information concerning the individual authorizations which they have granted under paragraph 1.
5.Checks on the persons authorized to engage in the activity of wholesaler in medicinal products and the inspection of their premises, shall be carried out under the responsibility of the Member State which granted the authorization.
6.The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorization if the conditions of authorization cease to be met. It shall forthwith inform the other Member States and the Commission thereof.
7.Should a Member State consider that, in respect of a person holding an authorization granted by another Member State under the terms of paragraph 1, the conditions of authorization are not, or are no longer met, it shall forthwith inform the Commission and the other Member State involved. The latter shall take the measures necessary and shall inform the Commission and the first Member State of the decisions taken and the reasons for those decisions.
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