1. Authorisation Number

:

374H

2. Name of Authorisation Holder

:

Arkopharma Belux SA

3. Address(es) of Site(s)

:

Parc de la Noire Epine, Avenue Edison 13, Wavre, 1300, Belgium 

4. Legally registered address of Authorisation Holder

:

Parc de la Noire Epine, Avenue Edison 13, Wavre, 1300, 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

:

2018-02-08

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

Name and address of the site: Arkopharma Belux SA

, Parc de la Noire Epine, Avenue Edison 13, Wavre, 1300, Belgium   

Any restrictions or clarifying remarks (for all users):  2.1 IC In :
Also procurement of medicinal products coming from countries of the European Economic Area (EEA) other than Belgium.

2.1 IC In :
Egalement acquisition de médicaments via d'autres pays de l'Espace économique européen (EEE) que la Belgique.

*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

374H

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