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
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2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS
2.1. Procurement
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3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS
3.3. Cold chain products(requiring low temperature handling)
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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
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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
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3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS
3.1.3. Immunological medicinal products
3.3. Cold chain products(requiring low temperature handling)
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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
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