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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-11-20

RTF Template

Icelandic Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	070
2. Name of Authorisation Holder	:	IsM ehf. (ORG-100048316 / LOC-100079970)
3. Address(es) of Site(s)	:	Borgartun 23, Reykjavik, 105, Iceland

4. Legally registered address of Authorisation Holder	:	Borgartun 23, Reykjavik, 105
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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-06-19
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: IsM ehf.

(ORG-100048316 / LOC-100079970)

, Borgartun 23, Reykjavik, 105, Iceland

Human medicinal products

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

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Sale (Supply) of medicinal products exempted from MA by the Icelandic Medicines Agency is only approved for patients in Iceland.

*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:

The company has requested suspension of their license since they have not performed any wholesale activities since the license was issued.

Union Format for a Wholesale Distribution Authorisation	070
	Page 1

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