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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-10-10

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_001_1_2_4_10
2. Name of Authorisation Holder	:	Creapharm Clinical Supplies (ORG-100020131 / LOC-100050437)
3. Address(es) of Site(s)	:	Zone D Activite Airspace, Avenue De Magudas, Le Haillan, 33185, France

4. Legally registered address of Authorisation Holder	:	Zone D Activite Airspace, Avenue De Magudas, Le Haillan, 33185, 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	:	2025-01-02
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: Creapharm Clinical Supplies

(ORG-100020131 / LOC-100050437)

, Zone D Activite Airspace, Avenue De Magudas, Le Haillan, 33185, France

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*

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) freezing, temperature -80°C --- congélation, température à -80°C

3.3. Other products: (please specify here or make a reference to Annex 5) medicinal products: derived from blood, immunological, investigational --- médicaments : dérivés du sang, immunologiques, expérimentaux

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°)
activity: storage with a view to the wholesale distribution without modification of products not owned by the company.

Distributor of investigational medicinal products (Public Health Code Article R.5124-2 10°)
Activity undertaken by order and on behalf of one or more sponsors as defined by Article L. 1121-1: storage operations with a view to the distribution without modification of investigational medicinal products manufactured or imported by companies or bodies as defined in paragraphs 1 and 2 of Article R. 5124-2.

Signatory: Mrs Florence Descamps-Delesalle, head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.

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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°), au stockage de ces médicaments ou produits, dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état.

Etablissement distributeur de médicaments expérimentaux (code de la santé publique art. R.5124-2 10°) se livrant, le cas échéant d'ordre et pour le compte d'un ou plusieurs promoteurs définis à l'article L.1121-1, au stockage en vue de leur distribution en l'état de médicaments expérimentaux fabriqués ou importés par des entreprises ou organismes définis au 1° ou au 2° de l'article R.5124-2.

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.

**Without prejudice to further authorisations as may be required according to national legislation.

Reason for Withdrawing:

replaced with authorisation 2025_238_1_2_4_10

remplacée par l'autorisation 2025_238_1_2_4_10

Union Format for a Wholesale Distribution Authorisation	2025_001_1_2_4_10
	Page 1

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