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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-05-13

RTF Template

French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	MM 17/106
2. Name of Authorisation Holder	:	ALLOGA FRANCE
3. Address(es) of Site(s)	:	ZAC de Chapotin Sud, CHAPONNAY, 69970, 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	:	2017-05-18
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 - CHAPONNAY

, ZAC de Chapotin Sud, CHAPONNAY, 69970, 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

2.5. Other activities(s): Exploitation.

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.2. Medicinal gases

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): this site is authorized as an ''exploitant''1.2 medicinal products with temporary authorization for use only2.5 the activity, including wholesale and distribution free of charge of operated products, consists in advertising, information, pharmacovigilance, batch follow-up, and if required, withdrawal operationsExploitation may involve all or part of medicinal products with additional requirementsCet établissement est dépositaire - This site is authorized as a "dépositaire" 1.1 : the activity is undertaken by order and on behalf of an "exploitant" 1.2 : medicinal products with temporary authorization for use, dressing objects or articles presented as complying with the Pharmacopoeia This site is authorized as a wholesale distributor for export the wholesale distributor for export distributes medicinal products outside the national territory

Cet établissement est exploitant 1.2 médicaments sous autorisation temporaire d'utilisation uniquement 2.5 l'activité, incluant la vente en gros et la cession à titre gratuit des produits exploités, comprend les opérations de publicité, information, pharmacovigilance, suivi des lots et, s'il y a lieu, leur retraitL'exploitation peut concerner tout ou partie des médicaments ayant des exigences particulières Cet établissement est dépositaire 1.1 : l'activité est exercée d'ordre et pour le compte d'un exploitant 1.2 : médicaments sous autorisation temporaire d'utilisation, objets de pansement ou articles présentés comme conformes à la Pharmacopée Cet établissement est distributeur en gros à l'exportation - le distributeur en gros à l'exportation distribue en gros les médicaments en dehors du territoire national

Reason for Withdrawing:

replaced by 2025_087_1_2_3_4_10

remplacée par 2025_087_1_2_3_4_10

Union Format for a Wholesale Distribution Authorisation	MM 17/106
	Page 1

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