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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	:	MM 14/461
2. Name of Authorisation Holder	:	LABORATOIRES ROSA PHYTOPHARMA
3. Address(es) of Site(s)	:	2 avenue du Traité de Rome, CHATOU, 78400, France

4. Legally registered address of Authorisation Holder	:	68 rue Jean-Jacques Rousseau, PARIS, 75001, 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	:	2014-09-11
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: LABORATOIRES ROSA PHYTOPHARMA - CHATOU

, 2 avenue du Traité de Rome, CHATOU, 78400, 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

2.3. Supply

2.4. Export

2.5. Other activities(s): Exploitation.

Any restrictions or clarifying remarks (for all users): This site is authorized as an ''exploitant''.1.2 medicinal products with temporary authorization for use only. 2.5 the activity, including wholesale and distribution free of charge of operated products, consists in advertising, information, pharmacovigilance, batch follow-up, and if required, withdrawal operations. Exploitation may involve all or part of medicinal products with additional requirements.

Cet établissement est exploitant.1.2 médicaments sous autorisation temporaire d'utilisation uniquement. 2.5 l'activité, incluant la vente en gros et la cession à titre gratuit des produits exploités, comprend les opérations de publicité, information, pharmacovigilance, suivi des lots et, s'il y a lieu, leur retrait. L'exploitation peut concerner tout ou partie des médicaments ayant des exigences particulières.

*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	MM 14/461
	Page 1

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