1. Authorisation Number

:

2021_219_4_5_15

2. Name of Authorisation Holder

:

RBP PHARMA SAS

3. Address(es) of Site(s)

:

ZA de Pré-Million 2, Bâtiment Bel Horizon, LA TERRASSE, 38660, France 

4. Legally registered address of Authorisation Holder

:

ZA de Pré-Million 2, Bâtiment Bel Horizon, LA TERRASSE, 38660, France

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:

7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

:

Confidential, Confidential

8. Signature

:

9. Date

:

2021-12-29

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: RBP PHARMA SAS

, ZA de Pré-Million 2, Bâtiment Bel Horizon, LA TERRASSE, 38660, France   

Any restrictions or clarifying remarks (for all users):  Dépositaire, wholesale distributor and central purchasing office (Public Health Code Article R.5124-2 4°, 5° and 15°)

4° storage, wholesale distribution of not owned medicinal products, by order and on behalf of exploitants
-
5° purchase, storage, distribution of medicinal products (except investigational); can distribute by order and on behalf of licensed pharmacists of pharmacy  or structures mentioned in Article D. 5125-24-16, on the national territory only, medicinal products (except investigational ones) and non refundable
-
15° purchase, storage, distribution to licensed pharmacists of pharmacy, on the national territory only, of non refundable medicinal products (except investigational ones)"

Signatory: Mr Said Ioughlissen, deputy head of pharmaceutical product inspection and counterfeiting fight department --- The ANSM does not issue hard copy of this authorisation.
---

Etablissement dépositaire, grossiste-répartiteur et centrale d'achat pharmaceutique (code de la santé publique art. R.5124-2 4°, 5° and 15°)

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
-
5° achat, stockage, distribution de médicaments non expérimentaux;  peut aussi distribuer d'ordre et pour le compte de titulaires d'officine ou de structures citées à l'art. D.5125-24-1, sur le territoire national uniquement, des médicaments non remboursables (hors médicaments expérimentaux)
-
15° achat, stockage, distribution à des pharmaciens titulaires d'officine, sur le territoire national uniquement, de médicaments non remboursables (hors médicaments expérimentaux)

Signataire : M. Said Ioughlissen, chef adjoint 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

2021_219_4_5_15

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