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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-09-18

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	7080-1
2. Name of Authorisation Holder	:	Vilomix Norway AS
3. Address(es) of Site(s)	:	Hensmoveien 30, HØNEFOSS, NO-3516, Norway

4. Legally registered address of Authorisation Holder	:	Hensmoveien 30, HØNEFOSS, NO-3516, Norway
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	:	2020-03-16
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: Vilomix Norway AS

, Hensmoveien 30, HØNEFOSS, NO-3516, Norway

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.5. Other activities(s): Direct distribution, cf. §§ 13-15 in the Regulation of 21 Dec 1993 on Distribution of Med. Products

Any restrictions or clarifying remarks (for all users): Medicinal products for use in animals only. | Applies only to oral powder with zinc oxide to be used on piglets. Sale to end users can only take place when prescribed by a veterinarian.

*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:

Expired 25 Jun 2022, not renewed (ZnO)

Union Format for a Wholesale Distribution Authorisation	7080-1
	Page 1

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