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RTF Template


National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

2025_055_5

2. Name of Authorisation Holder

:

COMPAGNIE D'EXPLOITATION ET DE REPARTITION PHARMACEUTIQUE

(ORG-100025161 / LOC-100055339)

3. Address(es) of Site(s)

:

Zone Industrielle De La Mirande, 2 Rue Des Grillons, St Esteve, 66240, France 




4. Legally registered address of Authorisation Holder

:

39-41 Rue Des Augustins, Rouen, 76000, France

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2025-03-14

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: COMPAGNIE D'EXPLOITATION ET DE REPARTITION PHARMACEUTIQUE

(ORG-100025161 / LOC-100042156)

, Zone Industrielle De La Mirande, 2 Rue Des Grillons, St Esteve, 66240, France   



Human medicinal products


1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation or registration in EEA country(s)

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

     3.2.2. Other temperatures: (please specify) freezing --- congélation

   3.3. Other products: (please specify here or make a reference to Annex 5)  medicinal products derived from blood, immunological medicinal products, medicinal gases  --- médicaments dérivés du sang, médicaments immunologiques, gaz médicinaux




Any restrictions or clarifying remarks (for all users):  -
Wholesale distributor (Public Health Code Article R.5124-2 5°)
Activity: purchasing and storage operations with a view to the wholesale distribution without modification of medicinal products other than investigational medicinal products;
An activity can also been undertaken by order and on behalf of:
- licensed pharmacists of pharmacy,
- or structures mentioned in Article D. 5125-24-16
for purchasing and storage operations of medicinal products other than investigational medicinal products, except for medicinal products which are refundable by mandatory health insurance schemes, with a view to their wholesale distribution without modification to licensed pharmacists of pharmacy on the national territory only.

Signatory: Mrs Solange Solbes, coordinator of the pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.

----------

Établissement grossiste-répartiteur (code de la santé publique art. R.5124-2 5°) se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;
peut également se livrer, d'ordre et pour le compte de pharmaciens titulaires d'officine ou des structures mentionnées à l'article D.5125-24-16, à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, à l'exception des médicaments remboursables par les régimes obligatoires d'assurance maladie, en vue de leur distribution en gros et en l'état et uniquement sur le territoire national.

Signataire : Mme Solange Solbes, coordinatrice 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, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**Without prejudice to further authorisations as may be required according to national legislation.













Union Format for a Wholesale Distribution Authorisation

2025_055_5


Page 1





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