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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-11-13

RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	MD 19/154
2. Name of Authorisation Holder	:	ETABLISSEMENT DE RAVITAILLEMENT SANITAIRE DES ARMEES
3. Address(es) of Site(s)	:	Camp de Sainte-Marthe, rue Jean Queillau, MARSEILLE, 13014, France

4. Legally registered address of Authorisation Holder	:	TSA 20003, FLEURY LES AUBRAIS, 45404, 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	:	2019-08-20
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: ETABLISSEMENT DE RAVITAILLEMENT SANITAIRE DES ARMEES

, Camp de Sainte-Marthe, rue Jean Queillau, MARSEILLE, 13014, 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

2.5. Other activities(s): ERSA

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.5, Wholesale distributor of military health services. The activity, including export of distributed products, consists of wholesale and distribution operations for medicinal products, products or objets stipulated L. 5124-8, by Order N°91-685 dated 14 July 1991, without clarifications.
Signatory: Mr Said Ioughlissen, deputy head of the pharmaceutical product inspection and counterfeiting fight department --- The ANSM does not issue hard copies of good practice certificates.
---

2.5. Distributeur en gros du service des armées. L'activité, incluant l'exportation des produits distribué, comprend les opérations de distribution en gros et en l'état des médicaments, produits ou objets mentionnés à l'article L. 5124-8, dans le cadre des attributions du service des armées fixées par le décret n°91-685 du 14 juillet 1991.
Signataire : M. Said Ioughlissen, chef adjoint du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes --- L'ANSM ne délivre pas de copies papier des certificats de bonnes pratiques.

*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

Reason for Withdrawing:

2024_152_13

Union Format for a Wholesale Distribution Authorisation	MD 19/154
	Page 1

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