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RTF Template


Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

22/02371-2

2. Name of Authorisation Holder

:

HI Giortz Sonner AS

(ORG-100043437 / LOC-100071855)

3. Address(es) of Site(s)

:

Sjukenesstranda 100, Eidsnes, 6037, Norway 




4. Legally registered address of Authorisation Holder

:

Sjukenesstranda 100, Eidsnes, 6037

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

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2022-03-08

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


ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION



Name and address of the site: HI Giortz Sonner AS

(ORG-100043437 / LOC-100071855)

, Sjukenesstranda 100, Eidsnes, 6037, Norway   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 



Any restrictions or clarifying remarks (for all users):  The authorisation only applies to medicinal products permitted sold outside pharmacies (LUA), cf. Regulations of 14 August 2003 on sale etc. of certain over-the-counter medicinal products outside pharmacies.
The permit covers the storage of medicines in transit for up to 48 hours, possibly over the weekend. Medicines returned from outlets and which are to be destroyed at ASKO SENTRALLAGER AS are not covered by this time limit.



*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

22/02371-2


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