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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-09-11

RTF Template

Norwegian Medical Products Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	24/23493-4
2. Name of Authorisation Holder	:	Abbvie AS (ORG-100003274 / LOC-100063212)
3. Address(es) of Site(s)	:	Lilleakerveien 8, Oslo, 0283, Norway

4. Legally registered address of Authorisation Holder	:	Lilleakerveien 8, Oslo, 0283
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	:	2025-04-22
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: Abbvie AS

(ORG-100003274 / LOC-100063212)

, Lilleakerveien 8, Oslo, 0283, Norway

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) IMP | Free samples

Any restrictions or clarifying remarks (for all users): Section 1.2 covers investigational medicinal products. | Section 1.2 also covers the medicinal product Depakote, approved for compassionate use, named patient, according to current rules, cf. Regulation relating to Medicines for Human Use section 2-5. This medicinal product is restricted to patients in Norway, who have been granted such exemption. For Depakote, manufactured in the United States and imported via the Netherlands, it is granted, pursuant to section 3-1, last paragraph of the Norwegian Regulation on Manufacture and Import of Medicinal Products, an exemption from the requirement that the medicinal product must be imported directly from the country in which it is manufactured, cf. section 3-6, second paragraph, of the same regulation. | Section 2.5 Direct distribution to professional end-users applies to deliveries of medicinal products for clinical trials directly to approved trial site.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Reason for Withdrawing:

A new version has been submitted.

Union Format for a Wholesale Distribution Authorisation	24/23493-4
	Page 1

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