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RTF Template


Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products


1. Authorisation Number

:

25/11534-4

2. Name of Authorisation Holder

:

Skretting AS

(ORG-100019424 / LOC-100093896)

3. Address(es) of Site(s)

:

Kristvikveien 205, Averoey, 6531, Norway 




4. Legally registered address of Authorisation Holder

:

Sjoehagen 6, Stavanger, 4016

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

:

2025-06-26

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: Skretting AS

(ORG-100019424 / LOC-100029296)

, Kristvikveien 205, Averoey, 6531, Norway   



Veterinary medicinal products


1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): (please specify) Distr. directly to prescribing veterinarian/fish health biologist of medicinal products to animals



Any restrictions or clarifying remarks (for all users):  The auth. only covers medicated feedstuff and medicated pellets from an approved manufacturer within the EEA.
Section 1.2 applies to:
• med. prod. granted exemption from MA, cf. Reg. relating to Veterinary Medicinal Products sections 4-1 and 11-2, the Act relating to Med. Prod. section 2d, and Reg. 2019/6/EU art. 112-114. These medicinal products are restricted for use on animals in Norway, for which such exemption has been granted.
• investigational medicinal products

Section 2.4 covers export to United Kingdom, The Faroe Islands and Russia.|
Section 2.5 only includes medicated feedstuff and medicated pellets to fish, dispensed after a prescription from a veterinarian and/or fish health biologist. Direct distribution should be performed according to Regulations of 2 June 2022 on requisitioning and dispensing of medicinal products etc., which demand control by a pharmacist of requisitions and dispensing of medicines.



*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.













Union Format for a Wholesale Distribution Authorisation

25/11534-4


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