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RTF Template

Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	FIMEA/2024/005512
2. Name of Authorisation Holder	:	KRKA Finland Oy (ORG-100019528 / LOC-100038228)
3. Address(es) of Site(s)	:	Tekniikantie 14, Espoo, 02150, Finland

4. Legally registered address of Authorisation Holder	:	Tekniikantie 14, Espoo, 02150, Finland
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 Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-10-01
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: Krka Finland Oy

(ORG-100019528 / LOC-100038228)

, Tekniikantie 14, Espoo, 02150, Finland

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.5. Other activities(s): Export to other EEA countries, Distribution of medicinal product samples

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.4. Other products: Medicinal product samples, Traditional herbal medicinal products

Any restrictions or clarifying remarks (for all users): 3.1.1. Narcotic or psychotropic products and 3.4. Traditional herbal medicinal products are limited to human medicinal products only.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	FIMEA/2024/005512
	Page 1

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