Name and address of the site: COMPAGNIE D'EXPLOITATION ET DE REPARTITION PHARMACEUTIQUE
(ORG-100025161 / LOC-100042156)
, Zone Industrielle De La Mirande, 2 Rue Des Grillons, St Esteve, 66240, France
Human medicinal products
1. MEDICINAL PRODUCTS
1.1. with a Marketing Authorisation or registration in EEA country(s)
1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*
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2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS
2.1. Procurement
2.2. Holding
2.3. Supply
2.4. Export
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3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS
3.1. Narcotic or psychotropic products**
3.2. Products requiring low temperature handling
3.2.1. Temperatures between 2 to 8 °C
3.2.2. Other temperatures: (please specify) freezing --- congélation
3.3. Other products: (please specify here or make a reference to Annex 5) medicinal products derived from blood, immunological medicinal products, medicinal gases --- médicaments dérivés du sang, médicaments immunologiques, gaz médicinaux
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Any restrictions or clarifying remarks (for all users): - Wholesale distributor (Public Health Code Article R.5124-2 5°) Activity: purchasing and storage operations with a view to the wholesale distribution without modification of medicinal products other than investigational medicinal products; An activity can also been undertaken by order and on behalf of: - licensed pharmacists of pharmacy, - or structures mentioned in Article D. 5125-24-16 for purchasing and storage operations of medicinal products other than investigational medicinal products, except for medicinal products which are refundable by mandatory health insurance schemes, with a view to their wholesale distribution without modification to licensed pharmacists of pharmacy on the national territory only.
Signatory: Mrs Solange Solbes, coordinator of the pharmaceutical product inspection and counterfeiting fight department The ANSM does not issue hard copy of this authorisation.
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Établissement grossiste-répartiteur (code de la santé publique art. R.5124-2 5°) se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ; peut également se livrer, d'ordre et pour le compte de pharmaciens titulaires d'officine ou des structures mentionnées à l'article D.5125-24-16, à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, à l'exception des médicaments remboursables par les régimes obligatoires d'assurance maladie, en vue de leur distribution en gros et en l'état et uniquement sur le territoire national.
Signataire : Mme Solange Solbes, coordinatrice du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes L'ANSM ne délivre pas de copie papier de cette autorisation.
*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.
**Without prejudice to further authorisations as may be required according to national legislation.
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