1. Authorisation Number

:

2024_144_7

2. Name of Authorisation Holder

:

Laboratoires Lafran

(ORG-100018334 / LOC-100027114)

3. Address(es) of Site(s)

:

Zone Industrielle La Madeleine, 12 Rue Jacquard, Evreux, 27000, France 

4. Legally registered address of Authorisation Holder

:

Zone Industrielle La Madeleine, 12 Rue Jacquard, Evreux, 27000

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

:

2024-05-30

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: Laboratoires Lafran

(ORG-100018334 / LOC-100027114)

, Zone Industrielle La Madeleine, 12 Rue Jacquard, Evreux, 27000, France   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  Wholesale distributor for export (Public Health Code Article R.5124-2 7°): purchasing and storage operations with a view to the export without modification, of:
- medicinal products other than investigational medicinal products,
- products, objects, articles, generators, kits or precursors mentioned in paragraphs 2° and 3° of Article L. 4211-1,
- medicinal plants stipulated in paragraph 5° of Article L. 4211-1.

Signatory: Mrs Solange Solbes, coordinator of pharmaceutical product inspection and counterfeiting fight department ---   The ANSM does not issue hard copy of this authorisation.

Etablissement distributeur en gros à l'exportation (code de la santé publique art. R.5124-2 7°) se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, d'objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L.4211-1, de plantes médicinales mentionnées au 5° de l'article L.4211-1, en vue de leur exportation en l'état.

Signataire: Mme Solange Solbes, coordinatrice du Pôle inspection des produits pharmaceutiques et lutte contre les fraudes. L'ANSM ne délivre pas de copie papier de cette autorisation.

Reason for Withdrawing:

replaced with decision 2026_092_1_7

remplacé par la décision  2026_092_1_7

Union Format for a Wholesale Distribution Authorisation

2024_144_7

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