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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-10

RTF Template

Finnish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	005026/06.08.00.04/2017
2. Name of Authorisation Holder	:	Baxter Oy
3. Address(es) of Site(s)	:	Tammasaarenkatu 1, Helsinki, FI-00180, Finland

4. Legally registered address of Authorisation Holder	:	PL 119, Helsinki, FI-00181, 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	:	2017-09-28
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: Baxter Oy

, Tammasaarenkatu 1, Helsinki, FI-00180, Finland

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Investigational medicinal products

Any restrictions or clarifying remarks (for all users): Holding of medicinal products is restricted only to medicinal products that are not used in humans or animals.

Supply is restricted only to contract giving of transportation from a manufacturer to a Finnish pharmacy, hospital pharmacy or dispensary (medicinal products with special permissions for compassionate use: sodium chloride solutions in pre-filled elastomeric pumps or syringes).

Reason for Withdrawing:

New WDA issued, authorisation number FIMEA/2024/007328-2

Union Format for a Wholesale Distribution Authorisation	005026/06.08.00.04/2017
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