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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	:	2022_301_1_2_10
2. Name of Authorisation Holder	:	Theradis Pharma (ORG-100025376 / LOC-100034590)
3. Address(es) of Site(s)	:	41 Chemin Des Presses, Cagnes-Sur-Mer, 06800, France

4. Legally registered address of Authorisation Holder	:	41 Chemin Des Presses, Cagnes-Sur-Mer, 06800
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-01-03
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: Theradis Pharma

(ORG-100025376 / LOC-100034590)

, 41 Chemin Des Presses, Cagnes-Sur-Mer, 06800, France

Human medicinal products

1. MEDICINAL PRODUCTS

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

2.2. 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

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: investigational medicinal products médicaments expérimentaux

Any restrictions or clarifying remarks (for all users): -
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.
---

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 or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	2022_301_1_2_10
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