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RTF Template


Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products


1. Authorisation Number

:

23/06487-2

2. Name of Authorisation Holder

:

Stim. AS

(ORG-100034625 / LOC-100078351)

3. Address(es) of Site(s)

:

Storeidoeya 60, Leknes, 8370, Norway 

Storeidoya Industrial Park, Leknes, 8370, Norway 




4. Legally registered address of Authorisation Holder

:

Storeidoeya 60, Leknes, 8370

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

:

2023-06-16

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: Stim. AS

(ORG-100034625 / LOC-100078351)

, Storeidoeya 60, Leknes, 8370, Norway   



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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  Section 1.2 applies only to medicinal products having been granted exemption from Marketing Authorisation , cf. Regulation relating to Veterinary Medicinal Products sections 4-1 and 11-2, the Act relating to Medicinal Products section 2d, and Regulation 2019//6/EU articles 112-114.
These medicinal products are restricted to patients in Norway who have been granted such exemption.


Name and address of the site: Stim. AS

(ORG-100034625 / LOC-100064187)

, Storeidoya Industrial Park, Leknes, 8370, Norway   



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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.5. Other activities(s): Direct distribution to professional end-users


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  Section 1.2 applies only  medicinal products having been granted exemption from Marketing Authorisation , cf. Regulation relating to Veterinary Medicinal Products sections 4-1 and 11-2, the Act relating to Medicinal Products section 2d, and Regulation 2019//6/EU articles 112-114.
These medicinal products are restricted to patients in Norway who have been granted such exemption
Section 2.5.2 applies to direct transportation to end users (fish farms) and only upon a prescription from a
veterinarian or fish health biologist at the receiving fish farm. Direct distribution should be performed according
to Regulations of 27 April 1998 § 6-1 on prescribing and delivery of medicinal products from pharmacies, which
demand control by a pharmacist of requisitions and dispensing of medicines



*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

23/06487-2


Page 1





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