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RTF Template

National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	2021_195_3
2. Name of Authorisation Holder	:	AOP ORPHAN PHARMACEUTICALS FRANCE
3. Address(es) of Site(s)	:	15 rue Jeanne Braconnier, MEUDON LA FORÊT, 92360, France

4. Legally registered address of Authorisation Holder	:	15 rue Jeanne Braconnier, MEUDON LA FORÊT, 92360, 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	:	2021-11-19
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: AOP ORPHAN PHARMACEUTICALS FRANCE

, 15 rue Jeanne Braconnier, MEUDON LA FORÊT, 92360, 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): -
Exploitant (Public Health Code Article R.5124-2 3°)
Exploitation of medicinal products other than investigational medicinal products: 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.

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

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Etablissement exploitant (code de la santé publique art. R.5124-2 3°)
Exploitation de médicaments autres que les médicaments expérimentaux : 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.

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

*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	2021_195_3
	Page 1

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