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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-10-01

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	23/11827-2
2. Name of Authorisation Holder	:	Nippon Gases Norge AS (ORG-100034456 / LOC-100064114)
3. Address(es) of Site(s)	:	Ringnesveien 50, Postboks 23, Oslo, 0915, Norway

4. Legally registered address of Authorisation Holder	:	Ringnesveien 50, Oslo, 0978
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-06-16
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: Nippon Gases Norge AS

(ORG-100002674 / LOC-100048483)

, Ringnesveien 50, Postboks 23, Oslo, 0915, Norway

Human 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

2.5. Other activities(s): Dir. distrib., cf. the Norw. Act on Med. Prod. etc. § 15, and Reg. on Distr. of Med. Prod. §§ 13-15

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): The authorization only covers medicinal gases. Section 1.2 applies only to medicinal products granted approval for compassionate use, named patient, by the Norwegian Medicines Agency, cf. Regulation of 18 December 2009 on Medicines, Sections 2-5 and 2-6. These medicinal products are restricted to patients in Norway who have been granted such approval. Section 2.5 grants the right to perform direct distribution to a professional end user of the medicinal products covered by the authorization, To nursing homes, cf. the Regulation of 21 December 1993 relating to the Distribution of Medicinal Products § 13 first section point 4 and § 14, which demand control by a pharmacist of requisitions and dispensing of medicines. To hospitals with hospital pharmacies or pharmaceutical departments, jf. the Reg of 21 December 1993 relating to the Distribution of Medicinal Products § 13 first section point 7. Direct distribution to hospitals assumes that requirements in Circular IK-21-95 are fulfilled.

Reason for Withdrawing:

Replaced by an updated version.

Union Format for a Wholesale Distribution Authorisation	23/11827-2
	Page 1

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