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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-11-13

RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	24/15718-2
2. Name of Authorisation Holder	:	Novartis Norge AS (ORG-100000598 / LOC-100093162)
3. Address(es) of Site(s)	:	Nydalsveien 28, Oslo, 0484, Norway

4. Legally registered address of Authorisation Holder	:	Nydalsveien 28, Oslo, 0484, Norway
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	:	2024-08-22
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: Novartis Norge AS

(ORG-100000598 / LOC-100093162)

, Nydalsveien 28, Oslo, 0484, 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

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: IMP | Free samples

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to:
• investigational medicinal products
• medicinal products manufactured in, and imported from, PIC/S countries, that requires approval for compassionate use, named patient, according to current rules, cf. Regulation relating to Medicines for Human Use, sections 2-5, and/or medicinal products having been granted exemption from Marketing Authorisation, cf. Regulation relating to Medicines for Human Use, section 2-8.
These medicinal products are restricted to patients in Norway who have been granted such exemption.

Reason for Withdrawing:

Replaced by updated version.

Union Format for a Wholesale Distribution Authorisation	24/15718-2
	Page 1

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