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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_066_4_5
2. Name of Authorisation Holder	:	COMPAGNIE D'EXPLOITATION ET DE REPARTITION PHARMACEUTIQUE (ORG-100025161 / LOC-100055339)
3. Address(es) of Site(s)	:	Quartier Triolo, 8 Rue Ticleni, Villeneuve D Ascq, 59493, France

4. Legally registered address of Authorisation Holder	:	39-41 Rue Des Augustins, Rouen, 76000, 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	:	2025-03-19
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: COMPAGNIE D'EXPLOITATION ET DE REPARTITION PHARMACEUTIQUE

(ORG-100025161 / LOC-100042746)

, Quartier Triolo, 8 Rue Ticleni, Villeneuve D Ascq, 59493, 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*

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. 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 --- congélation

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

Any restrictions or clarifying remarks (for all users): -
Dépositaire, wholesale distributor (Public Health Code Article R.5124-2 n°4 et 5)

4° dépositaire : storage, wholesale distribution of not owned medicinal products, by order and on behalf of exploitants;

5° wholesale distributor : purchase, storage, distribution of medicinal products (except investigational); can distribute by order and on behalf of licensed pharmacists of pharmacy or structures mentioned in Article D. 5125-24-16, on the national territory only, medicinal products (except investigational ones) and non refundable.

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

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Établissement dépositaire, grossiste-répartiteur (Code de la santé publique Article R.5124-2 n°4 et 5)

4° dépositaire : stockage, distribution en gros et en l'état de médicaments dont il n'est pas propriétaire, d'ordre et pour le compte d'exploitants ;

5° grossiste-répartiteur : achat, stockage, distribution de médicaments non expérimentaux ; peut aussi distribuer d'ordre et pour le compte de titulaires d'officine ou de structures citées à l'art. D.5125-24-1, sur le territoire national uniquement, des médicaments non remboursables (hors médicaments expérimentaux).

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.

*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.

Union Format for a Wholesale Distribution Authorisation	2025_066_4_5
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