1. Authorisation Number

:

2025_136_1_2_4

2. Name of Authorisation Holder

:

Mayoly Industrie

(ORG-100004511 / LOC-100001713)

3. Address(es) of Site(s)

:

20 Rue Ethe Virton, Dreux, 28100, France 

4. Legally registered address of Authorisation Holder

:

20 Rue Ethe Virton, Dreux, 28100, France

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

:

2025-04-01

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: Mayoly Industrie

(ORG-100004511 / LOC-100001713)

, 20 Rue Ethe Virton, Dreux, 28100, France   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  Dépositaire (Public Health Code Article R.5124-2 4°)
acting by order and on behalf of:
- one or more "exploitants" of medicinal products, generators, kits and precursors (Article L.4211-1 3°),
- one or more manufacturers or importers of dressing objects or articles presented as complying with the French pharmacopoeia mentioned in Article L.4211-1 2°,
activity: storage with a view to the wholesale distribution without modification of medicines, products, objects or articles not owned by the company.

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 dépositaire (code de la santé publique art. R.5124-2 4°) se livrant, d'ordre et pour le compte :
-d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs (art. L.4211-1 3°),
-ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée cités à l'art. L.4211-1 2°,
au stockage de ces médicaments ou produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état.

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_136_1_2_4

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