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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_153_4

2. Name of Authorisation Holder

:

Centre Specialites Pharmaceutiques

(ORG-100008565 / LOC-100014787)

3. Address(es) of Site(s)

:

Le Petit Sarlieve, 16 Rue De La Fave, Cournon D Auvergne, 63800, France 




4. Legally registered address of Authorisation Holder

:

76-78 Avenue Du Midi, Cournon D Auvergne, 63800

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

:

2025-05-14

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: Centre Specialites Pharmaceutiques

(ORG-100008565 / LOC-100054687)

, Le Petit Sarlieve, 16 Rue De La Fave, Cournon D Auvergne, 63800, 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

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 




Any restrictions or clarifying remarks (for all users):  -
Dépositaire (Public Health Code Article R.5124-2 4°)
acting by order and on behalf of:
- one or more "exploitants" of medicinal products, generators, kits and precursors (Article L.4211-1 3°),
- one or more manufacturers or importers of dressing objects or articles presented as complying with the French pharmacopoeia mentioned in Article L.4211-1 2°,
activity: storage with a view to the wholesale distribution without modification of medicines, products, objects or articles not owned by the company.

3.1.1 limited to psychotropic products, excluding narcotics.

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

--------

Établissement dépositaire (code de la santé publique art. R.5124-2 4°) 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°),
-ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée cités à l'art. L.4211-1 2°,
au stockage de ces médicaments ou produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état.

3.1.1 limité aux psychotropes, exclut les médicaments stupéfiants.

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, 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_153_4


Page 1





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