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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_134_4_7_15

2. Name of Authorisation Holder

:

Tridem Pharma

(ORG-100032088 / LOC-100050217)

3. Address(es) of Site(s)

:

Zone Dactivite La Balme, 2 Rue Des Pyrenees, Belberaud, 31450, France 




4. Legally registered address of Authorisation Holder

:

Zac De La Masquere, 500 Rue De L Hers, Escalquens, 31750, France

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

:

2025-03-28

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: Tridem Pharma

(ORG-100032088 / LOC-100079373)

, Zone Dactivite La Balme, 2 Rue Des Pyrenees, Belberaud, 31450, 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

   2.1. 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 




Any restrictions or clarifying remarks (for all users):  -
Dépositaire, wholesale distributor for export and central purchasing office (Public Health Code article R. 5124-2 n° 4°, 7° and 15°)

4° storage, wholesale distribution of medicinal products, not owned by the company, by order and on behalf of exploitants of medicinal products or products mentioned in Article L.4211-1 3° or manufacturers or importers of products mentioned in Article L.4211-1 2°
--

7° purchase, storage with a view to the export without modification of medicinal products other than investigational medicinal products and products mentioned in article L. 4211-1 2°, 3°, 5°
--

15° purchase, storage, distribution to licensed pharmacists of pharmacy, on the national territory only, of non refundable medicinal products (except investigational ones).

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

Dépositaire, distributeur en gros à l'exportation et centrale d'achat pharmaceutique (code de la Santé Publique article R. 5124-2 n° 4°, 7° et 15°)

4° stockage, distribution en gros et en l'état de médicaments dont il n'est pas propriétaire, d'ordre et pour le compte d'exploitants de médicaments ou de produits cités à l'article L.4211-1 3° ou de fabricants ou importateurs de produits cités à l'article L.4211-1 2°
--

7° achat, stockage en vue de l'exportation en l'état de médicaments autres que des médicaments expérimentaux et de produits cités à l'article L.4211-1 2°, 3°, 5°
--

15° achat, stockage, distribution à des pharmaciens titulaires d'officine, sur le territoire national uniquement, de 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_134_4_7_15


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