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RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	D 13/154
2. Name of Authorisation Holder	:	CAP DEPO
3. Address(es) of Site(s)	:	allée Delamare Debouteville, ZAC de Quicangrogne Bâtiment 1, BOURG ACHARD, 27310, France

4. Legally registered address of Authorisation Holder	:	allée Delamare Debouteville, ZAC de Quicangrogne Bâtiment 1, BOURG ACHARD, 27310, France
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2013-09-17
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: CAP DEPO - BOURG ACHARD

, allée Delamare Debouteville, ZAC de Quicangrogne Bâtiment 1, BOURG ACHARD, 27310, France

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): This site is authorized for the following activities :''dépositaire'' 1.1 : the activity is undertaken by order and on behalf of an ''exploitant''1.2: medicinal products with temporary authorization for use, dressing objects or articles presented as complying with pharmacopeia or pharmacy-repackaged products.distributor of investigational medicinal productscentral purchasing office. A central purchasing office is not authorized to distribute medicinal products which are refundable by mandatory health insurance schemes and is not authorized to distribute medicinal products outside the national territory.

Cet établissement est autorisé pour les activités suivantes : Dépositaire 1.1 : l'activité est exercée d'ordre et pour le compte d'un exploitant.1.2 : médicaments sous autorisation temporaire d'utilisation, objets de pansement ou articles présentés comme conformes à la pharmacopée ou de produits officinaux divisés.Distributeur de médicaments expérimentauxCentrale d'achat pharmaceutique. La centrale d'achat pharmaceutique n'est pas autorisée à distribuer les médicaments remboursables par les régimes obligatoires d'assurance maladie et n'est pas autorisée à distribuer de médicaments en dehors du territoire national.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	D 13/154
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