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RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	25/04009-17
2. Name of Authorisation Holder	:	Birk Nordic Pharma Consulting AS (ORG-100036891 / LOC-100058280)
3. Address(es) of Site(s)	:	Nydalsveien 28, Oslo, 0484, Norway

4. Legally registered address of Authorisation Holder	:	Nydalsveien 28, Oslo, 0484
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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-07-21
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: Birk Nordic Pharma Consulting AS

(ORG-100036891 / LOC-100058280)

, Nydalsveien 28, Oslo, 0484, Norway

Human 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*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Section 1.2 only applies to Indocid manufactured in, and imported from Australia, which requires approval for compassionate use, named patient, according to current rules, cf. Regulation relating to Medicines for Human Use, sections 2-5. The medicinal product is restricted to patients in Norway who have been granted such approval.

*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	25/04009-17
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