1. Authorisation Number

:

2023_238_4_5

2. Name of Authorisation Holder

:

Ubipharm-Mayotte

(ORG-100034566 / LOC-100054838)

3. Address(es) of Site(s)

:

Zae Vallee III, Koungou, 97600, France 

4. Legally registered address of Authorisation Holder

:

Zae Vallee III, Koungou, 97600

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

:

2023-12-07

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: Ubipharm-Mayotte

(ORG-100034566 / LOC-100054838)

, Zae Vallee III, Koungou, 97600, France   

Human medicinal products

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

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°

5°: purchase, storage, wholesale distribution without modification of medicinal products other than investigational medicinal products; 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 by mandatory health insurance schemes

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 dépositaire et grossiste-répartiteur (code de la santé publique art. R.5124-2 4° et 5°)

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°

5° : achat, stockage, distribution en gros et en l'état de médicaments autres que des médicaments expérimentaux ; peut distribuer d'ordre et pour le compte de pharmaciens titulaires d'officine ou de structures citées à l'art. D.5125-24-16, sur le territoire national uniquement, des médicaments non remboursables par les régimes obligatoires d'assurance maladie (hors médicaments expérimentaux)

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

2023_238_4_5

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