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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-08-18

RTF Template

Norwegian Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	23/22018-2
2. Name of Authorisation Holder	:	Janssen-Cilag AS (ORG-100000610 / LOC-100006606)
3. Address(es) of Site(s)	:	Drammensveien 288, Oslo, 0283, Norway

4. Legally registered address of Authorisation Holder	:	Drammensveien 288, 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	:	2023-10-31
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: Janssen-Cilag AS

(ORG-100000610 / LOC-100006606)

, Drammensveien 288, Oslo, 0283, Norway

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Other products: Free samples | Interim storage of complaints for return to factory for analysis

Reason for Withdrawing:

Replaced by updated version.

Union Format for a Wholesale Distribution Authorisation	23/22018-2
	Page 1

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