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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-11-04

RTF Template

Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	FIMEA/2025/002230-2
2. Name of Authorisation Holder	:	Novartis Finland Oy (ORG-100000260 / LOC-100096389)
3. Address(es) of Site(s)	:	Revontulenkuja 1, Espoo, 02100, Finland

4. Legally registered address of Authorisation Holder	:	Revontulenkuja 1, Espoo, 02100
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	:	2025-05-08
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 Finland Oy

(ORG-100000260 / LOC-100096389)

, Revontulenkuja 1, Espoo, 02100, Finland

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) Distribution of medicinal product samples and export to other EEA countries

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) below -120°C, and -60°C or below

3.3. Other products: (please specify here or make a reference to Annex 5) Medicines for clinical reseach

Any restrictions or clarifying remarks (for all users): 2.3 Supply: Physical supply is limited to hospital pharmacy supplies of gene therapy products and corresponding investigational products, and medicinal products with special permission in acute situations.

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

Reason for Withdrawing:

New WDA issued, Authorisation Number: FIMEA/2026/006338-2

Union Format for a Wholesale Distribution Authorisation	FIMEA/2025/002230-2
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