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RTF Template


Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

1865 H

2. Name of Authorisation Holder

:

Belgium Parcels Service SRL (en abrégé: B.P.S.)

3. Address(es) of Site(s)

:

Hoge Wei 5, Zaventem, 1930, Belgium 




4. Legally registered address of Authorisation Holder

:

Avenue Hermann-Debroux, 54, Auderghem, 1160, Belgium

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

:

2020-01-08

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: Belgium Parcels Service SRL (en abrégé: B.P.S.)

, Hoge Wei 5, Zaventem, 1930, Belgium   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 



Any restrictions or clarifying remarks (for all users):  the storage of medicines requiring specific storage conditions is not authorized in the locations located directly in the hot air flow located near the probe located at the hot spot (location S4L4) in the "Small Depot".

Le stockage de médicaments nécessitant des conditions spécifiques de conservation n'est pas autorisé dans les emplacements situés directement dans le flux d'air chaud situé à proximité de la sonde située au point chaud (emplacement S4L4) dans le « Petit Dépôt ».



*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

1865 H


Page 1





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