1. Authorisation Number

:

2023_133_7

2. Name of Authorisation Holder

:

Biessen Pharma

(ORG-100037124 / LOC-100058661)

3. Address(es) of Site(s)

:

6 Boulevard Georges Marie Guynemer, St Cyr L Ecole, 78210, France 

4. Legally registered address of Authorisation Holder

:

35 Avenue Des Champs Elysees, Paris, 75008

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

:

2023-06-07

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: Biessen Pharma

(ORG-100037124 / LOC-100064603)

, 6 Boulevard Georges Marie Guynemer, St Cyr L Ecole, 78210, France   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  -
Wholesale distributor for export (Public Health Code Article R.5124-2 7°): purchasing and storage operations with a view to the export without modification, of:
- medicinal products other than investigational medicinal products,
- products, objects, articles, generators, kits or precursors mentioned in paragraphs 2° and 3° of Article L. 4211-1,
- medicinal plants stipulated in paragraph 5° of Article L. 4211-1.

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

-------

Établissement distributeur en gros à l'exportation (code de la santé publique art. R.5124-2 7°) se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, d'objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L.4211-1, de plantes médicinales mentionnées au 5° de l'article L.4211-1, en vue de leur exportation en l'état.

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

2023_133_7

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