1. Authorisation Number

:

2022_180_1_4_7

2. Name of Authorisation Holder

:

Sanofi Winthrop Industrie

(ORG-100011564 / LOC-100072023)

3. Address(es) of Site(s)

:

18 Rue Des Vieilles Vignes, Croissy-Beaubourg, 77183, France 

Zac Du Couternois, 7 Avenue Louise Amelie Leblois, Serris, 77700, 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)

:

Annexe de Stockage - SANOFI WINTHROP INDUSTRIE, Serris 

4. Legally registered address of Authorisation Holder

:

82 Avenue Raspail, Gentilly, 94250

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

:

2023-02-24

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: Sanofi Winthrop Industrie

(ORG-100011564 / LOC-100022113)

, 18 Rue Des Vieilles Vignes, Croissy-Beaubourg, 77183, France   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  -
Dépositaire and wholesale distributor for export (Public Health Code Article R.5124-2 4° and 7°)

4° storage, wholesale distribution of medicinal products, not owned by the company, by order and on behalf of exploitants of medicinal products or products mentioned in Article L.4211-1 3° or manufacturers or importers of products mentioned in Article L.4211-1 2°

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 dépositaire et distributeur en gros à l'exportation (code de la santé publique art. R.5124-2 4° et  7°)

4° stockage, distribution en gros et en l'état de médicaments dont il n'est pas propriétaire, d'ordre et pour le compte d'exploitants de médicaments ou de produits cités à l'article L.4211-1 3° ou de fabricants ou importateurs de produits cités à l'article L.4211-1 2°

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°" 201 "Wholesale distributor for export

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.

Name and address of the site: Sanofi Winthrop Industrie

(ORG-100011564 / LOC-100073336)

, Zac Du Couternois, 7 Avenue Louise Amelie Leblois, Serris, 77700, France   

Additional details on units inspected of site(s) address(es) (optional) (All authorised sites should be listed if not covered by separate authorisations): Annexe de Stockage - SANOFI WINTHROP INDUSTRIE, Serris

Human medicinal products

Any restrictions or clarifying remarks (for all users):  -
2.2: storage facility according to Article R. 5124-7, I of the French Public Health Code.
-

2.2 : locaux de stockage selon les dispositions de l'article R. 5124-7, I du code de la santé publique.

*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

Reason for Withdrawing:

replaced with authorisation  2024_111_1_2_4_7

remplacée par l'autorisation 2024_111_1_2_4_7

Union Format for a Wholesale Distribution Authorisation

2022_180_1_4_7

Page 1