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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-03-11

RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	24/13868-2
2. Name of Authorisation Holder	:	Roche Norge AS (ORG-100003003 / LOC-100009719)
3. Address(es) of Site(s)	:	Brynsengfaret 6 B, Oslo, 0667, Norway

4. Legally registered address of Authorisation Holder	:	Brynsengfaret 6 B, Oslo, 0667
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	:	2024-10-29
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: Roche Norge AS

(ORG-100003003 / LOC-100009719)

, Brynsengfaret 6 B, Oslo, 0667, 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

2.3. Supply

2.5. Other activities(s): (please specify) Direct distribution to professional end-users

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products | IMP

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to:

• Medicinal products on approved compassionate use program (CUP) in Norway by the Norwegian Medical Products Agency rules, cf. Regulation of 18 December 2009 on Medicines Section 2-8, and clinical batches of Gavreto (pratelsinib) to Norwegian study patient, imported from Germany on approval for compassionate use, named patient, according to current rules, cf. Regulation of 18 December 2009 on Medicines Sections 2-5. Medicinal products imported from third countries must be manufactured in the country from which they are imported, cf. the Regulation of 2 November 2004 on Manufacture and Import of Medicinal Products section 3-6.
• Investigational medicinal products.

Section 2.5 applies only to investigational medicinal products.

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

**Without prejudice to further authorisations as may be required according to national legislation.

Reason for Withdrawing:

Replaced by updated version

Union Format for a Wholesale Distribution Authorisation	24/13868-2
	Page 1

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