1. Authorisation Number

:

2023_200_1_2_3_10

2. Name of Authorisation Holder

:

Assistance Publique Hopitaux De Paris

(ORG-100004082 / LOC-100073479)

3. Address(es) of Site(s)

:

7 Rue Du Fer A Moulin, Bp 9, Paris Cedex 05, 75221, France 

3.a. Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations)

:

AGEPS 

4. Legally registered address of Authorisation Holder

:

55 Boulevard Diderot, Cs 22305, Paris Cedex 12, 75610

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

:

2023-08-25

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: Etablissement Pharmaceutique De L Assistance Publique Des Hopitaux De Paris

(ORG-100012644 / LOC-100022316)

, 7 Rue Du Fer A Moulin, Bp 9, Paris Cedex 05, 75221, France   

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): AGEPS

Human medicinal products

Any restrictions or clarifying remarks (for all users):  Exploitant (Public Health Code Article R.5124-2 3°) Exploitation of medicinal products other than investigational medicinal products, generators, kits and precursors (Article L.4211-1 3 °): wholesale and distribution free of charge, advertising, information, pharmacovigilance, batch follow-up and recall; may concern all or part of the medicinal products with additional requirements

Distributor of investigational medicinal products (Public Health Code Article R.5124-2 10°)
Activity undertaken by order and on behalf of one or more sponsors as defined by Article L. 1121-1: storage operations with a view to the distribution without modification of investigational medicinal products manufactured or imported by companies or bodies as defined in paragraphs 1 and 2 of Article R. 5124-2

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 exploitant (code de la santé publique art. R.5124-2 3°) Exploitation de médicaments autres que les médicaments expérimentaux, de générateurs, trousses et précurseurs (art. L.4211-1 3°) : vente en gros ou cession à titre gratuit, publicité, information, pharmacovigilance, suivi et retrait des lots; peut concerner tout ou partie des médicaments ayant des exigences particulières

Etablissement distributeur de médicaments expérimentaux (code de la santé publique art. R.5124-2 10°) se livrant, le cas échéant d'ordre et pour le compte d'un ou plusieurs promoteurs définis à l'article L.1121-1, au stockage en vue de leur distribution en l'état de médicaments expérimentaux fabriqués ou importés par des entreprises ou organismes définis au 1° ou au 2° de l'article R.5124-2

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_200_1_2_3_10

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