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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	:	24/15895-7
2. Name of Authorisation Holder	:	Apotek 1 Gruppen AS (ORG-100025038 / LOC-100034226)
3. Address(es) of Site(s)	:	Leiraveien 13b, Lillestroem, 2000, Norway

4. Legally registered address of Authorisation Holder	:	Skaarersletta 55, Loerenskog, 1473, 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	:	2024-12-04
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: Apotek 1 Gruppen AS

(ORG-100025038 / LOC-100078101)

, Leiraveien 13b, Lillestroem, 2000, Norway

Human medicinal products

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*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) 3.4.3 Active substances - API

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to:
For human medicinal products: Medicinal products manufactured in, and imported from, PIC/S countries, that requires approval for compassionate use, named patient, according to current rules, cf. Regulation relating to Medicines for Human Use, section 2-5, and medicinal products having been granted a licence to sell foreign packages in connection to medicine shortage.
For veterinary medicinal products: 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 2 d, and Regulation 2019//6/EU articles 112-114.

These medicinal products are restricted to patients/for use in animals in Norway for which such exemption has been granted.

This authorisation also applies to the location: SNØ avfallsrom, Luhrtoppen 2, 1470 Lørenskog, Norway.

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

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	24/15895-7
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