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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-06-30

RTF Template

National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	2021_120_1_4_10
2. Name of Authorisation Holder	:	ALLOGA FRANCE
3. Address(es) of Site(s)	:	ZA les Mulottières, SEICHES SUR LE LOIR, 49140, France

4. Legally registered address of Authorisation Holder	:	40 boulevard de Dunkerque, MARSEILLE, 13002, 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	:	2021-07-13
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: ALLOGA FRANCE - SEICHES SUR LE LOIR

, ZA les Mulottières, SEICHES SUR LE LOIR, 49140, 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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: investigational medicinal products médicaments expérimentaux

Any restrictions or clarifying remarks (for all users): -
Dépositaire & distributor of investigational medicinal products (Public Health Code Article R.5124-2 4° & 10°)

4° dépositaire acting by order and on behalf of one or more "exploitants" of medicinal products other than investigational medicinal products, generators, kits and precursors (Article L.4211-1 3°)
activity: storage with a view to the wholesale distribution without modification of medicines or products, not owned by the company

10° distributor of investigational medicinal products
activity undertaken by order and on behalf of one or more sponsors as defined by Article L. 1121-1: storage operations with a view to the distribution without modification of investigational medicinal products manufactured or imported by companies or bodies as defined in paragraphs 1 and 2 of Article R. 5124-2

Signatory: Mrs Mélanie Cachet, deputy director - Inspection division
The ANSM does not issue hard copy of this authorisation.
_

Etablissement dépositaire & distributeur de médicaments expérimentaux (code de la santé publique art. R.5124-2 4° & 10°)

4° dépositaire se livrant, d'ordre et pour le compte d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs (art. L.4211-1 3°) au stockage de ces médicaments ou produits, dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état

10° distributeur de médicaments expérimentaux se livrant, le cas échéant d'ordre et pour le compte d'un ou plusieurs promoteurs définis à l'article L.1121-1, au stockage en vue de leur distribution en l'état de médicaments expérimentaux fabriqués ou importés par des entreprises ou organismes définis au 1° ou au 2° de l'article R.5124-2

Signataire: Mme Mélanie Cachet, directrice adjointe - Direction de l'inspection
L'ANSM ne délivre pas de copie papier de cette autorisation.

Reason for Withdrawing:

replaced by 2025_167_1_2_4_10

remplacée par 2025_167_1_2_4_10

Union Format for a Wholesale Distribution Authorisation	2021_120_1_4_10
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