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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-10-04

RTF Template

Icelandic Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	008
2. Name of Authorisation Holder	:	Fastus ehf.
3. Address(es) of Site(s)	:	Síðumúli 16, Reykjavík, IS-108, Iceland

4. Legally registered address of Authorisation Holder	:	Síðumúli 16, Reykjavík, IS-108, Iceland
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-05-22
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: Fastus ehf.

, Síðumúli 16, Reykjavík, IS-108, Iceland

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.4. Radiopharmaceuticals (including radionuclide kits)

Any restrictions or clarifying remarks (for all users): 3.1.4: The company does not store radiopharmaceuticals, they are transported directly to the end-user from the manufacturer.

*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

Reason for Withdrawing:

An updated WDA has been issued.

Union Format for a Wholesale Distribution Authorisation	008
	Page 1

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