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RTF Template

Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	FIMEA/2023/006316
2. Name of Authorisation Holder	:	Octapharma Nordic Ab Suomen sivuliike (ORG-100010546 / LOC-100017405)
3. Address(es) of Site(s)	:	Rajatorpantie 41 C, Vantaa, Helsinki-Uusimaa, 01640, Finland

4. Legally registered address of Authorisation Holder	:	Rajatorpantie 41 C, Vantaa, Helsinki-Uusimaa, 01640, Finland
4.a. Additional details on units inspected of registrant's legal address (optional)	:	Archiving and customer complaint samples: c/o Biocodex Oy, Metsänneidonkuja 4, 02130 Espoo
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	:	2023-12-08
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: Octapharma Nordic Ab Suomen sivuliike

(ORG-100010546 / LOC-100017405)

, Rajatorpantie 41 C, Vantaa, Helsinki-Uusimaa, 01640, Finland

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) Immunological and blood derived products

Union Format for a Wholesale Distribution Authorisation	FIMEA/2023/006316
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