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RTF Template

Agence nationale de sécurité du médicament et des produits de santé

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	D 16/279
2. Name of Authorisation Holder	:	CAILLEAU PHARMACEUTIQUE
3. Address(es) of Site(s)	:	6 rue de Strasbourg, Zone Anjou Actiparc des 3 Routes Ouest, CHEMILLE EN ANJOU, 49120, France

4. Legally registered address of Authorisation Holder	:	6 rue de Strasbourg, Zone Anjou Actiparc des 3 Routes Ouest, CHEMILLE EN ANJOU, 49120, 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	:	2016-09-15
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: CAILLEAU PHARMACEUTIQUE - CHEMILLE EN ANJOU

, 6 rue de Strasbourg, Zone Anjou Actiparc des 3 Routes Ouest, CHEMILLE EN ANJOU, 49120, France

1. MEDICINAL PRODUCTS

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

2.5. Other activities(s): Quality control.Contrôle qualité.

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.4. Other products: medicinal plants. plantes médicinales.

Any restrictions or clarifying remarks (for all users): This site is authorized as a wholesale distributor of medicinal plants; the activity consists of storage and control operations as well as those necessary for the wholesale distribution in bulk, in sachets, fragments or in fresh or dry state of medicinal plants. 2.5 wholesale distributor of medicinal plants performes quality control of distributed plants under all specification of the Pharmacopoiea (L. 5112-1 and R. 5112-2 of the French Public Health Code).

Cet établissement est distributeur en gros de plantes médicinales et se livre au stockage et aux contrôles et opérations nécessaires pour la distribution en gros et en vrac, en sachets-doses, en fragments ou à l'état frais ou desséché de plantes médicinales. 2.5 le distributeur en gros de plantes médicinales effectue le contrôle de la qualité des plantes distribuées conformément à l'ensemble des spécifications de la Pharmacopée (L. 5112-1 et R. 5112-2 du code de la santé publique).

*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 16/279
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