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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-10-08

RTF Template

Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	FIMEA/2021/003130
2. Name of Authorisation Holder	:	Organon Finland Oy
3. Address(es) of Site(s)	:	Puolikkotie 8, Espoo, FI-02230, Finland

4. Legally registered address of Authorisation Holder	:	Puolikkotie 8, Espoo, FI-02230, Finland
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	:	2021-05-25
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: Organon Finland Oy

, Puolikkotie 8, Espoo, FI-02230, Finland

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.4. Export

2.5. Other activities(s): Export to other EEA countries

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.4. Export is limited to medicinal products that are not used in human or animal.

Reason for Withdrawing:

New WDA issued, Authorisation Number: FIMEA/2026/005002-2

Union Format for a Wholesale Distribution Authorisation	FIMEA/2021/003130
	Page 1

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