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RTF Template


Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

21/23965-3

2. Name of Authorisation Holder

:

Kolly AS

3. Address(es) of Site(s)

:

Kveldroveien 5, VINTERBRO, NO-1407, Norway 




4. Legally registered address of Authorisation Holder

:

Kveldroveien 5, VINTERBRO, NO-1407, Norway

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

:

2020-02-06

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: Kolly AS

, Kveldroveien 5, VINTERBRO, NO-1407, Norway   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.4. Other products: Medicinal products approved for sale in outlets other than pharmacies




Any restrictions or clarifying remarks (for all users):  The authorisation only covers medicinal products approved for sale in outlets other than pharmacies, cf the Regulation of 14 August 2003 on
Sales of certain non-prescription medicinal products in outlets not defined as pharmacies.



*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

21/23965-3


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