Finnish Medicines Agency
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
002841/06.08.00.04/2019
2. Name of Authorisation Holder
Biogen Finland Oy
3. Address(es) of Site(s)
Bertel Jungin Aukio 5 C, Espoo, FI-02600, Finland
4. Legally registered address of Authorisation Holder
Bertel Jungin aukio 5 C, Espoo, FI-02600, 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
2019-05-06
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: Biogen Finland Oy
, Bertel Jungin Aukio 5 C, Espoo, FI-02600, Finland
1.1. with a Marketing Authorisation in EEA country(s)
2.1. Procurement
2.5. Other activities(s): Export to other EEA countries, distribution of medicinal product samples
3.3. Cold chain products(requiring low temperature handling)
3.4. Other products: Medicinal product samples
Reason for Withdrawing:
New WDA issued, authorisation number: FIMEA/2026/001977-2
Union Format for a Wholesale Distribution Authorisation
Page 1
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