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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	:	2024_333_5
2. Name of Authorisation Holder	:	Delta Pharma (ORG-100053403 / LOC-100094373)
3. Address(es) of Site(s)	:	8 Rue Des Peupliers, Verquieres, 13670, France

4. Legally registered address of Authorisation Holder	:	8 Rue Des Peupliers, Verquieres, 13670, 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	:	2024-12-11
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: Delta Pharma

(ORG-100053403 / LOC-100094373)

, 8 Rue Des Peupliers, Verquieres, 13670, 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

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

Any restrictions or clarifying remarks (for all users): -
Wholesale distributor (Public Health Code Article R.5124-2 5°)
Activity: purchasing and storage operations with a view to the wholesale distribution without modification of medicinal products other than investigational medicinal products;
An activity can also been undertaken by order and on behalf of:
- licensed pharmacists of pharmacy,
- or structures mentioned in Article D. 5125-24-16
for purchasing and storage operations of medicinal products other than investigational medicinal products, except for medicinal products which are refundable by mandatory health insurance schemes, with a view to their wholesale distribution without modification to licensed pharmacists of pharmacy on the national territory only.

Signatory: Mrs Bénédicte Bertholom, deputy director - Inspection division
The ANSM does not issue hard copy of this authorisation.

----------------

Établissement grossiste-répartiteur (code de la santé publique art. R.5124-2 5°) se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;
peut également se livrer, d'ordre et pour le compte de pharmaciens titulaires d'officine ou des structures mentionnées à l'article D.5125-24-16, à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, à l'exception des médicaments remboursables par les régimes obligatoires d'assurance maladie, en vue de leur distribution en gros et en l'état et uniquement sur le territoire national.

Signataire: Mme Bénédicte Bertholom, directrice adjointe - Direction de l'inspection
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	2024_333_5
	Page 1

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