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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-10-24

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	23/14477-2
2. Name of Authorisation Holder	:	Alliance Healthcare Norge AS (ORG-100017348 / LOC-100026145)
3. Address(es) of Site(s)	:	Håndverksveien 31, LANGHUS, NO-1405, Norway

4. Legally registered address of Authorisation Holder	:	Haandverksveien 31, Langhus, 1405
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	:	2023-07-05
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: Alliance Healthcare Norge AS, Prewholesale (Håndverksveien)

, Håndverksveien 31, LANGHUS, NO-1405, Norway

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

2.2. Holding

2.3. Supply

2.5. Other activities(s): Storage of unreleased medicinal products in quarantine. Holding of free samples on behalf of other

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: IMP

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to medicinal products manufacured in, and imported from, PIC/S countries, and granted approval for compassionate use, named patient, by the Norwegian Medicines Agency, cf. Regulation of 18 December 2009 on Medicines, Sections 2-5 and 2-6. These medicinal products are restricted to patients in Norway who have been granted such approval.

Reason for Withdrawing:

Replaced by updated version.

Union Format for a Wholesale Distribution Authorisation	23/14477-2
	Page 1

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