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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_168_15

2. Name of Authorisation Holder

:

Essentiels Pharma

(ORG-100025278 / LOC-100064735)

3. Address(es) of Site(s)

:

1 Rue De L Ardeliere, Beaucouze, 49070, France 




4. Legally registered address of Authorisation Holder

:

1 Rue De L Ardeliere, Beaucouze, 49070

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

:

2025-05-14

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: Essentiels Pharma

(ORG-100025278 / LOC-100064735)

, 1 Rue De L Ardeliere, Beaucouze, 49070, France   



Human medicinal products


1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation or registration 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.

Storage is limited to medicinal products without additional requirements.

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

--------

Établissement 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.

Le stockage est limité aux médicaments sans exigences particulières.

Signataire: Mme Florence Descamps-Delesalle, chef du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes / 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.















Union Format for a Wholesale Distribution Authorisation

2025_168_15


Page 1





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