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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	:	MD 18/056
2. Name of Authorisation Holder	:	ASSISTANCE MEDICALE TOIT DU MONDE
3. Address(es) of Site(s)	:	81 avenue du Maréchal Joffre, NANTERRE, 92000, France

4. Legally registered address of Authorisation Holder	:	81 avenue du Maréchal Joffre, 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	:	2018-03-13
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: ASSISTANCE MEDICALE TOIT DU MONDE

, 81 avenue du Maréchal Joffre, 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

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

Any restrictions or clarifying remarks (for all users): -
Wholesale distributor for humanitarian purposes (Public Health Code Article R.5124-2 8°):
activity of the non-profit body stipulated in Article L. 5124-7 : acquisition operations without or against payment and storage of medicinal products other than investigational medicinal products with a view to their non-profit wholesale distribution or export.

Signatory: Mrs Mélanie Cachet, head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.
-

Etablissement distributeur en gros à vocation humanitaire (code de la santé publique art. R.5124-2 8°) :
organisme à but non lucratif mentionné à l'article L.5124-7 se livrant à l'acquisition à titre gratuit ou onéreux et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros ou de leur exportation sans but lucratif.

Signataire: Mme Mélanie Cachet, chef 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	MD 18/056
	Page 1

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