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RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	24/29490-2
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 (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	:	2024-12-16
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: GE Healthcare AS - Fabrikk Oslo

, Nycoveien 1, OSLO, NO-0485, Norway

Human 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

2.5. Other activities(s): (please specify) distribution of radiopharmaceuticals directly to hospitals

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) 3.1.4 Radiopharmaceuticals (including radionuclide kits) 3.4.1 Investigational medicinal products

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 Medical Products Agency, cf. Regulation of 18
December 2009 on Medicines, Sections 2-5. These medicinal products are restricted to patients in Norway
who have been granted such approval.
Section 2.5.2 applies to covers direct distribution of the following PET- nuclides: F18 FES, F18-Flurpiridaz,
F18-FAPI, F18-FDG og F18-Flutemetamol with marketing authorization (MA) and/or under Named patient
supply (NPS).

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

Union Format for a Wholesale Distribution Authorisation	24/29490-2
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