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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	:	MD 16/261
2. Name of Authorisation Holder	:	PHARMASTOCK
3. Address(es) of Site(s)	:	Usine du Gros Moulin, 326 route de Châteaurenard, AMILLY, 45200, France

4. Legally registered address of Authorisation Holder	:	127 rue d'Aguesseau, BOULOGNE BILLANCOURT, 92100, 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	:	2016-10-17
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: PHARMASTOCK - AMILLY

, Usine du Gros Moulin, 326 route de Châteaurenard, AMILLY, 45200, 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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): This site is authorized as a "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 the Pharmacopoeia.

Cet établissement est 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.

*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	MD 16/261
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