1. Authorisation Number

:

2022_282_6_7

2. Name of Authorisation Holder

:

Les Laboratoires Servier

(ORG-100000964 / LOC-100000973)

3. Address(es) of Site(s)

:

Site Des 3 Arches, Pharma Park, Boigny Sur Bionne, 45760, 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)

:

SERVIER DISTRIBUTION 

4. Legally registered address of Authorisation Holder

:

50 Rue Carnot, Suresnes Cedex, 92284

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

:

2023-01-23

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: Les Laboratoires Servier

(ORG-100000964 / LOC-100076497)

, Site Des 3 Arches, Pharma Park, Boigny Sur Bionne, 45760, France   

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

Human medicinal products

Any restrictions or clarifying remarks (for all users):  -
Wholesale distributor of pharmaceutical products other than medicinal products and intermediate products and wholesale distributor for export (Public Health Code Article R.5124-2 6° and 7°)

6° purchase, storage, distribution of intermediates wich undergoe further processing by an authorised manufacturer /or/ products mentioned in Article L.4211-1 2° and 3°

7° purchase, storage with a view to the export without modification of medicinal products other than investigational medicinal products and products mentioned in article L. 4211-1 2°, 3°, 5°

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 distributeur en gros de produits pharmaceutiques autres que les médicaments et de produits intermédiaires et distributeur en gros à l'exportation (code de la santé publique art. R.5124-2 6° et 7°)

6° achat, stockage, distribution en gros et en l'état de produits intermédiaires destinés à une transformation ultérieure par un fabricant autorisé /ou/ de produits cités à l'article L.4211-1 2°, 3°

7° achat, stockage en vue de l'exportation en l'état de médicaments autres que des médicaments expérimentaux et de produits cités à l'article L.4211-1 2°, 3°, 5°

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

2022_282_6_7

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