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RTF Template


French National Agency for Medicines and Health Products Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

MD 18/156

2. Name of Authorisation Holder

:

SOCIETE REUNIONNAISE DE DISTRIBUTION PHARMACEUTIQUE - SOREDIP

3. Address(es) of Site(s)

:

11 rue du Pressoir, ZAC Portail, PITON SAINT LEU, 97424, France 




4. Legally registered address of Authorisation Holder

:

11 rue du Pressoir, ZAC Portail, PITON SAINT-LEU, 97424, France

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:


7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2018-09-04

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: SOCIETE REUNIONNAISE DE DISTRIBUTION PHARMACEUTIQUE - SOREDIP

, 11 rue du Pressoir, ZAC Portail, PITON SAINT LEU, 97424, France   




1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation in EEA country(s)

   1.2. without a Marketing Authorisation 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

     3.1.1. 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) 




Any restrictions or clarifying remarks (for all users):  -
-Dépositaire (Public Health Code Article R.5124-2 4°)
activity: 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°

-Wholesale distributor (Public Health Code Article R.5124-2 5°)
activity: purchase, storage, wholesale distribution without modification of medicinal products other than investigational medicinal products; 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 by mandatory health insurance schemes

Signatory: Mrs Mélanie Cachet, head of pharmaceutical product inspection and counterfeiting fight department
The ANSM does not issue hard copy of this authorisation.
_

-Etablissement dépositaire (code de la santé publique art. R.5124-2 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°"

-Etablissement grossiste-répartiteur (code de la santé publique art. R.5124-2 5°) :
achat, stockage, distribution en gros et en l'état de médicaments autres que des médicaments expérimentaux ; peut distribuer d'ordre et pour le compte de pharmaciens titulaires d'officine ou de structures citées à l'art. D.5125-24-16, sur le territoire national uniquement, des médicaments non remboursables par les régimes obligatoires d'assurance maladie (hors médicaments expérimentaux)

Signataire: Mme Mélanie Cachet, 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

MD 18/156


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