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RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Veterinary medicinal products

1. Authorisation Number	:	23/03899
2. Name of Authorisation Holder	:	Chemco AS (ORG-100036935 / LOC-100058354)
3. Address(es) of Site(s)	:	Marikovvegen 50, STRUSSHAMN, NO-5302, Norway

4. Legally registered address of Authorisation Holder	:	Marikovvegen 50, Strusshamn, 5302
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-04-20
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: Chemco AS

, Marikovvegen 50, STRUSSHAMN, NO-5302, 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

2.5. Other activities(s): Direct transportation of hydrogen peroxide with an MA in Norway

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The authorisation covers medicinal products for animals only.
The authorisation includes hydrogen peroxide dispensed upon a prescription from a veterinarian, and the short term storage on fish carriers in connection with transportation of hydrogen peroxide to and between fish farms.
Section 2.5.2. only applies to direct transportation of hydrogen peroxide with a marketing authorisation (MA) in Norway or exempted from MA by the Norwegian Medicines Agency.
Section 3.3 only applies to the storage facilities at Marikovvegen 50, Strusshamn.

*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

Union Format for a Wholesale Distribution Authorisation	23/03899
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