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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-02-11

RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	23/08693-10
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
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	:	2024-04-12
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 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

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.2. Medicinal gases

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: 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.

Reason for Withdrawing:

Replaced by a updated version

Union Format for a Wholesale Distribution Authorisation	23/08693-10
	Page 1

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