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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-12-05

RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	24/06239-2
2. Name of Authorisation Holder	:	Skretting AS (ORG-100019424 / LOC-100042330)
3. Address(es) of Site(s)	:	Industriveien 10, STOKMARKNES, NO-8450, Norway

4. Legally registered address of Authorisation Holder	:	Sjoehagen 16, Stavanger, 4016
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-03-15
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 - Stokmarknes

, Industriveien 10, STOKMARKNES, NO-8450, 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): Distribution directly to prescribing veterinarian/fish health biologist of med. prod. to animals

Any restrictions or clarifying remarks (for all users): The authorisation only applies to medicated feedstuff from an approved manufacturer within the EEA.
Section 1.2 applies 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 for use on animals in Norway, for which such exemption has been granted.
• investigational medicinal products

Section 2.5 applies to storage of unreleased medicinal products in quarantine, and direct distribution of medicated feedstuff to fish, dispensed after a prescription from a veterinarian and/or fish health biologist.

Reason for Withdrawing:

replaced by updated version.

Union Format for a Wholesale Distribution Authorisation	24/06239-2
	Page 1

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