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RTF Template


Medicines Evaluation Board

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products


1. Authorisation Number

:

2960 G

2. Name of Authorisation Holder

:

Keromed B.V.

(ORG-100043094 / LOC-100071288)

3. Address(es) of Site(s)

:

Zwolleweg 33, Barneveld, 3771 NR, Netherlands 




4. Legally registered address of Authorisation Holder

:

Zwolleweg 33, Barneveld, 3771 NR

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

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 99 of Regulation (EU) 2019/6

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2018-7-9

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: Keromed B.V.

(ORG-100043094 / LOC-100071288)

, Zwolleweg 33, Barneveld, 3771 NR, Netherlands   



Veterinary medicinal products


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

   1.3. without a Marketing Authorisation in the EEA and intended for exportation



*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

2960 G


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