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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-09-17

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	:	2022_175_7
2. Name of Authorisation Holder	:	Pharma Lab (ORG-100004723 / LOC-100004355)
3. Address(es) of Site(s)	:	Zone Internationale D'activites De Fontenoy, Gondreville, 54840, France

4. Legally registered address of Authorisation Holder	:	1 B Rue Du Havre, Paris, 75008
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	:	2022-08-09
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: Pharma Lab

(ORG-100004723 / LOC-100008799)

, Zone Internationale D'activites De Fontenoy, Gondreville, 54840, France

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

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 Florence Descamps-Delesalle, head 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 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.

Reason for Withdrawing:

replaced with 2026_165_7

remplacé par Décision 2026_165_7

Union Format for a Wholesale Distribution Authorisation	2022_175_7
	Page 1

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