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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-09-05

RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	MM 15/91
2. Name of Authorisation Holder	:	BIOGARAN
3. Address(es) of Site(s)	:	15 boulevard Charles de Gaulle, COLOMBES, 92700, France

4. Legally registered address of Authorisation Holder	:	15 boulevard Charles de Gaulle, COLOMBES, 92700, France
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2015-03-31
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: BIOGARAN - COLOMBES

, 15 boulevard Charles de Gaulle, COLOMBES, 92700, 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 authorised as an ''exploitant''1.2 medicinal products with temporary authorisation for use only.2.5 the activity, including whole sale 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 part of medicinal products with additional requirements.

Cet établissement est exploitant1.2 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.

Reason for Withdrawing:

replaced by 2025_139_3

remplacé par 2025_139_3

Union Format for a Wholesale Distribution Authorisation	MM 15/91
	Page 1

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