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RTF Template


National Agency For The Safety Of Medicine And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

2025_169_3

2. Name of Authorisation Holder

:

Medynex

(ORG-100052952 / LOC-100093382)

3. Address(es) of Site(s)

:

135 Boulevard Pereire, Paris, 75017, France  ACTIVE




4. Legally registered address of Authorisation Holder

:

14-30 Rue De Mantes, 4e Etage, Gauche Batiment D Le Charlebourg, Colombes, 92700

5. Scope of authorisation

:

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 wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2025-05-14

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


ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION



Name and address of the site: Medynex

(ORG-100052952 / LOC-100095554)

, 135 Boulevard Pereire, Paris, 75017, France    ACTIVE



Human medicinal products


1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation or registration in EEA country(s)

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): (please specify) Exploitation



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.



____

"Etablissement 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, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.













Union Format for a Wholesale Distribution Authorisation

2025_169_3


Page 1





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