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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-10-20

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	21/21411-2
2. Name of Authorisation Holder	:	dne pharma as
3. Address(es) of Site(s)	:	Karihaugveien 22, OSLO, NO-1086, Norway

4. Legally registered address of Authorisation Holder	:	Karihaugveien 22, OSLO, NO-1086, Norway
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	:	2021-09-10
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: dne pharma as

, Karihaugveien 22, OSLO, NO-1086, Norway

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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.4. Other products: API

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to active substances (APIs) manufactured or released in the EEA. | Section 2.4 applies only to the export of Ventizolve 1.26 mg nasal spray to the United Kingdom.

Reason for Withdrawing:

Replaced by updated version

Union Format for a Wholesale Distribution Authorisation	21/21411-2
	Page 1

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