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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-12-20

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	22/30979-2
2. Name of Authorisation Holder	:	Navamedic AS (ORG-100045791 / LOC-100075490)
3. Address(es) of Site(s)	:	Henrik Ibsens Gate 100, Oslo, 0255, Norway

4. Legally registered address of Authorisation Holder	:	Henrik Ibsens Gate 90, Oslo, 0255
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	:	2023-01-11
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: Navamedic AS

(ORG-100045791 / LOC-100077431)

, Henrik Ibsens Gate 100, Oslo, 0255, 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

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to Epistatus manufactured and released in United Kingdom and approved for compassionate use, named patient, according to current rules, cf. Regulation of 18 December 2009 on Medicines, Section 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	22/30979-2
	Page 1

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