1. Authorisation Number

:

2024_129_5

2. Name of Authorisation Holder

:

Ag Pharm

(ORG-100050918 / LOC-100089023)

3. Address(es) of Site(s)

:

23 Avenue Christian Doppler, Bailly Romainvilliers, 77700, France 

4. Legally registered address of Authorisation Holder

:

23 Avenue Christian Doppler, Bailly Romainvilliers, 77700

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

:

2024-05-16

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

Name and address of the site: Ag Pharm

(ORG-100050918 / LOC-100089023)

, 23 Avenue Christian Doppler, Bailly Romainvilliers, 77700, France   

Human medicinal products

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 Mélanie Cachet, deputy director - Inspection division.  The ANSM does not issue hard copy of this authorisation.

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Etablissement 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 Mélanie Cachet, directrice adjointe - Direction de l'inspection. 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

2024_129_5

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