Federal Agency for Medicines and Health Products
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
503 H
2. Name of Authorisation Holder
Servier R&D Benelux SA
3. Address(es) of Site(s)
Boulevard International 57, Bruxelles, 1070, Belgium
4. Legally registered address of Authorisation Holder
5. Scope of authorisation
ANNEX 1
6. Legal basis of authorisation
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation
Confidential, Confidential
8. Signature
9. Date
2017-12-18
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: Servier R&D Benelux SA
, Boulevard International 57, Bruxelles, 1070, Belgium
1.2. without a Marketing Authorisation in the EEA and intended for EEA market
2.1. Procurement
2.3. Supply
Reason for Withdrawing:
after a note by inspector for radiation:indicating that the logistics of clinical studies are managed by thefrom France.
Union Format for a Wholesale Distribution Authorisation
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