1. Authorisation Number

:

2024_105_3

2. Name of Authorisation Holder

:

Dentsply Sirona France

(ORG-100004935 / LOC-100009293)

3. Address(es) of Site(s)

:

Immeuble Le Colbert, 7 T Rue De La Porte De Buc, Versailles, 78000, France 

4. Legally registered address of Authorisation Holder

:

Immeuble Le Colbert, 7 T Rue De La Porte De Buc, Versailles, 78000

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

:

2024-04-16

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: Dentsply Sirona France

(ORG-100004935 / LOC-100009293)

, Immeuble Le Colbert, 7 T Rue De La Porte De Buc, Versailles, 78000, France   

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.

Signatory: Mrs Florence Descamps-Delesalle, head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.

------

Établissement 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.

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

2024_105_3

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