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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

:

2023_112_15

2. Name of Authorisation Holder

:

C2M

(ORG-100034493 / LOC-100054671)

3. Address(es) of Site(s)

:

1500 Avenue De Cos, Montauban, 82000, France 




4. Legally registered address of Authorisation Holder

:

1500 Avenue De Cos, Montauban, 82000

5. Scope of authorisation (complete for each site under 4)

:

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 wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2023-05-17

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: C2M

(ORG-100034493 / LOC-100054671)

, 1500 Avenue De Cos, Montauban, 82000, France   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 



Any restrictions or clarifying remarks (for all users):  Central purchasing office (Public Health Code Article R.5124-2 15°) acting:
-on its behalf and for its account,
-or by order and on behalf of licensed pharmacists of pharmacy or structures mentioned in Article D. 5125-24-16
Activity: purchasing and storage operations with a view to the wholesale distribution without modification,  to licensed pharmacists of pharmacy, on the national territory only, of medicinal products other than investigational medicinal products, except for medicinal products which are refundable by mandatory health insurance scheme

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


----

Etablissement centrale d'achat pharmaceutique (code de la santé publique art. R.5124-2 15°) se livrant, soit en son nom et pour son compte, soit 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 en vue de leur distribution en gros et en l'état, à des pharmaciens titulaires d'officine, sur le territoire national uniquement, des médicaments autres que des médicaments expérimentaux, à l'exception des médicaments remboursables par les régimes obligatoires d'assurance maladie

Signataire : Mme Florence Descamps-Delesalle, 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

2023_112_15


Page 1





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