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RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	22/05857-2
2. Name of Authorisation Holder	:	MSD (Norge) AS (ORG-100008840 / LOC-100069600)
3. Address(es) of Site(s)	:	Haakon VIIs Gate 5, Oslo, 0161, Norway

4. Legally registered address of Authorisation Holder	:	Haakon VIIs Gate 5, Oslo, 0161
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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-04-01
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: MSD (Norge) AS

(ORG-100008840 / LOC-100069600)

, Haakon VIIs Gate 5, Oslo, 0161, Norway

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.5. Other activities(s): Direct distribution of certain human investigational medicinal products

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Investigational medicinal products

Any restrictions or clarifying remarks (for all users): Section 1.2 applies only to:
• Lagevrio (molnupiravir) manufactured in, and imported from, EEA countries, that requires approval for compassionate use, named patient, according to current rules, cf. Regulation of 18 December 2009 on Medicines Section 2-5. These medicinal products are restricted to patients in Norway where such approval have been granted.
• investigational medicinal products

*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	22/05857-2
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