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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The WDA has been withdrawn, withdrawn date is: 2024-09-18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	:	7083-1
2. Name of Authorisation Holder	:	Felleskjøpet Rogaland Agder SA
3. Address(es) of Site(s)	:	Sandvikveien 33, STAVANGER, NO-4016, Norway

4. Legally registered address of Authorisation Holder	:	Sandvikveien 21, STAVANGER, NO-4016, 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	:	2018-10-25
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: Felleskjøpet Rogaland Agder SA

, Sandvikveien 33, STAVANGER, NO-4016, Norway

1. MEDICINAL PRODUCTS

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): Applies only to oral powder with zinc oxide to be used on piglets, exempted from Marketing Authorisation (MA) by the Norwegian Medicines Agency (NoMA). Sale to end users can onlv 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 22 Feb 2022, not renewed (ZnO)

Union Format for a Wholesale Distribution Authorisation	7083-1
	Page 1

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