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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-07-11

RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	1563 H
2. Name of Authorisation Holder	:	Mundipharma (ORG-100027259 / LOC-100077011)
3. Address(es) of Site(s)	:	De Kleetlaan 4, Machelen, 1831, Belgium

4. Legally registered address of Authorisation Holder	:	De Kleetlaan 4, Machelen, 1831
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	:	2023-02-01
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: Mundipharma

(ORG-100027259 / LOC-100077011)

, De Kleetlaan 4, Machelen, 1831, Belgium

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

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)

Any restrictions or clarifying remarks (for all users): 3.3: Authorized temperature for the cold chain: 2-8°C

3.3: Geneesmiddelen die op een lage temperatuur bewaard dienen te worden: 2-8°C.

Reason for Withdrawing:

made new WDA due to technical problems with update of the WDA

Union Format for a Wholesale Distribution Authorisation	1563 H
	Page 1

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