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RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	24/03896-3
2. Name of Authorisation Holder	:	Arnika AS (ORG-100020044 / LOC-100058641)
3. Address(es) of Site(s)	:	Teglverksveien 47, Solbergelva, 3057, Norway

4. Legally registered address of Authorisation Holder	:	Teglverksveien 47, Solbergelva, 3057, Norway
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 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	:	2024-07-15
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: Arnika AS

(ORG-100020044 / LOC-100058641)

, Teglverksveien 47, Solbergelva, 3057, Norway

Human medicinal products

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

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 covers homeopathic and anthroposophical medicinal products, herbs and herbal products which are considered to be medicinal products, herbal medicinal products, medicinal products exempted from marketing authorisation (MA) and approved for named patient use by the Norwegian Medical Products Agency, and Thyroid NAF 30, 60 and 120 mg tablets purchased from Kragerø tablet factory.
Products classified as medicinal products in Norway, but as supplements/foodstuff in the EEA countries, Canada and the United States, must be authorised for sale as supplements or foodstuff in the country they are exported from.
For medicinal products without a Norwegian MA, the legislation concerning exemptions from marketing authorisations must be followed, cf. the General Regulation of 18 December 2009 relating to Medicinal Products, § 2-5. These medicinal products are restricted to patients in Norway having been granted such exemption. |
Section 2.2 includes third party storage.

*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	24/03896-3
	Page 1

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