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RTF Template


Danish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products


1. Authorisation Number

:

103668

2. Name of Authorisation Holder

:

Region Sjaelland

(ORG-100023219 / LOC-100055658)

3. Address(es) of Site(s)

:

Vestermarksvej 6, Roskilde, 4000, Denmark 




4. Legally registered address of Authorisation Holder

:

Vestermarksvej 6, Roskilde, 4000

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

:

2024-04-29

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: Region Sjaelland

(ORG-100023219 / LOC-100055658)

, Vestermarksvej 6, Roskilde, 4000, Denmark   



Veterinary medicinal products


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.5. Other activities(s): Importation of substances from third countries.



Any restrictions or clarifying remarks (for all users):  The authorisation is limited to substance groups with the following properties; narcotic. Importation of substances from third countries: The holder of the authorisation must ensure that substances are only procured from companies who is authorised to distribute certain substances according to national legislation in the exporting country. Receipt control should be carried out according to the GDP rules.



*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

103668


Page 1





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