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RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	25/05065-2
2. Name of Authorisation Holder	:	Viking Life-Saving Equipment Norway AS (ORG-100020460 / LOC-100053111)
3. Address(es) of Site(s)	:	Oluf Onsums Vei 11, Oslo, 0680, Norway

4. Legally registered address of Authorisation Holder	:	Tybakken 90, Faervik, 4818
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-05-01
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: Viking Life-Saving Equipment Norway AS

(ORG-100020460 / LOC-100039129)

, Oluf Onsums Vei 11, Oslo, 0680, Norway

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

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

Any restrictions or clarifying remarks (for all users): The authorisation only covers packages of tablets for motion sickness (Postafen), in addition to medicinal products prepackaged in watertight, sealed containers required in rescue equipment for ship (life rafts and boats) and with a Norwegian MA. | The authorisation is restricted to sale of med. prod. to service stations approved by the Norwegian Maritime Authority. | The authorisation also applies to the distribution of med. prod. to foreign ships (SOLAS) | The service stations can only store the current med. prod. for a short period, pending deployment of the med. prod. in rescue equipment for ship. When, between services, there is a need to replace med. prod. that have already been deployed on lifeboats, the service stations can sell med. prod. prepacked in watertight, sealed containers to companies which have permission to requisition med. prod. for ships. | The service stations can only sell equipment containing med. prod. to comp which have permission to requisition med. prod.

Union Format for a Wholesale Distribution Authorisation	25/05065-2
	Page 1

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