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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-02-03

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	7115-1
2. Name of Authorisation Holder	:	GE Healthcare AS
3. Address(es) of Site(s)	:	Nycoveien 1, OSLO, NO-0485, Norway

4. Legally registered address of Authorisation Holder	:	Nycoveien 1, OSLO, NO-0485, Norway
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-11-21
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: GE Healthcare AS - Fabrikk Oslo

, Nycoveien 1, OSLO, NO-0485, Norway

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): distribution of radiopharmaceuticals directly to hospitals

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: IMP

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to medicinal products manufactured in and imported from PIC / S countries, and 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 only covers direct distribution of the following own PET- nuclides: 18F-FDG (SteriPET) and 18F-flutemetamol (under Named Patient Supply). Further restrictions on retail distribution of radiopharmaceuticals is stipulated in the wholesale distribution authorisation for medicinal products issued by the Norwegian Medicines Agency 21 November 2019.

Reason for Withdrawing:

Replaced by updated version.

Union Format for a Wholesale Distribution Authorisation	7115-1
	Page 1

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