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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	:	MM 19/137
2. Name of Authorisation Holder	:	LES LABORATOIRES BROTHIER
3. Address(es) of Site(s)	:	41 RUE DE NEUILLY, NANTERRE, 92000, France

4. Legally registered address of Authorisation Holder	:	41 RUE DE NEUILLY, NANTERRE, 92000, 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	:	2019-07-01
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: LES LABORATOIRES BROTHIER

, 41 RUE DE NEUILLY, NANTERRE, 92000, 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

2.5. Other activities(s): Exploitation.

Any restrictions or clarifying remarks (for all users): Etablissement exploitant (code de la santé publique art. R.5124-2 3°)
Exploitation de médicaments autres que les médicaments expérimentaux, de générateurs, trousses et précurseurs (art. L.4211-1 3°) : vente en gros ou cession à titre gratuit, publicité, information, pharmacovigilance, suivi et retrait des lots; peut concerner tout ou partie des médicaments ayant des exigences particulières
seul le stockage est limité aux catégories citées en 3

Signataire : M. Said Ioughlissen, chef adjointe au Pôle inspection des produits pharmaceutiques et lutte contre les fraudes
L'ANSM ne délivre pas de copie papier de cette autorisation.

Exploitant (Public Health Code Article R.5124-2 3°)
Exploitation of medicinal products other than investigational medicinal products, generators, kits and precursors (Article L.4211-1 3 °): wholesale and distribution free of charge, advertising, information, pharmacovigilance, batch follow-up and recall; may concern all or part of the medicinal products with additional requirements
only storage is limited to the categories mentioned in 3

Signatory: Mr Said Ioughlissen, deputy head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.

*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 19/137
	Page 1

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