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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-05-08

RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	1028 H
2. Name of Authorisation Holder	:	Janssen-Cilag NV
3. Address(es) of Site(s)	:	Antwerpseweg 15-17, Beerse, 2340, Belgium

4. Legally registered address of Authorisation Holder	:	Antwerpseweg 15-17, Beerse, 2340, Belgium
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-12-11
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 NV

, Antwerpseweg 15-17, Beerse, 2340, Belgium

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.1.: Also procurement of medicinal products coming from countries of the European Economic Area (EEA) other than Belgium.
3.3.: Authorized temperature for the cold chain : 2-8°C

2.1.: Alsook het verkrijgen van geneesmiddelen uit landen van de Europese Economische Ruimte (EER) anders dan België.
3.3.: Toegestane temperatuur voor de koude bewaring : 2-8°C

Reason for Withdrawing:

new WDA available - no longer possible to use the update button

Union Format for a Wholesale Distribution Authorisation	1028 H
	Page 1

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