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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-13

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	23/02402-2
2. Name of Authorisation Holder	:	Helm Skandinavien (ORG-100037021 / LOC-100058514)
3. Address(es) of Site(s)	:	Ytre Strandvei 2, Krageroe, 3770, Norway

4. Legally registered address of Authorisation Holder	:	Ytre Strandvei 2, Krageroe, 3770
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-02-02
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: Helm Skandinavien

(ORG-100037021 / LOC-100058514)

, Ytre Strandvei 2, Krageroe, 3770, Norway

Veterinary medicinal products

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

2.4. Export

2.5. Other activities(s): Direct distribution to professional end-users

Any restrictions or clarifying remarks (for all users): A prerequisite for this authorisation is that the company's contact person in Norway maintains the necessary communication with the Norwegian Medicines Agency regarding this authorisation, including maintenance of the authorisation and our supervision of the wholesale activities. The contact person shall have sufficient knowledge of relevant Norwegian legislation and the content of the authorisation.
Hydrogen peroxide used as a veterinary medicinal product is subject to legislation under the jurisdiction of the Ministry of Justice and Public Security, administered by the Norwegian Directorate for Civil Protection (DSB).

Reason for Withdrawing:

Withdrawn upon request from company.

Union Format for a Wholesale Distribution Authorisation	23/02402-2
	Page 1

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