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RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	25/00811-2
2. Name of Authorisation Holder	:	Apotek 1 Gruppen AS (ORG-100025038 / LOC-100034226)
3. Address(es) of Site(s)	:	Hamnegata 11, Stord, 5411, 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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-02-07
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-100079316)

, Hamnegata 11, Stord, 5411, Norway

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.5. Other activities(s): (please specify) 2.5.2 Direct distribution

Any restrictions or clarifying remarks (for all users): The authorisation only covers medicinal products that are prepackaged in watertight, sealed containers required in rescue equipment for ship (life rafts and boats). |
The authorisation only covers medicinal products with a Norwegian marketing authorisation purchased from an approved wholesaler. |
The authorisation is restricted to sale of medicinal products to service stations that are approved by the Norwegian Maritime Authority. The service stations can only store the current medicinal products for a short period, pending deployment of the medicinal products in rescue equipment for ship. The service stations can only sell rescue equipment containing medicinal products to companies that have permission to buy medicinal products. |
The authorization also applies to the distribution of medicinal products to foreign ships, (SOLAS).

*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	25/00811-2
	Page 1

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