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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-10-07

RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	1240 H
2. Name of Authorisation Holder	:	Ibis Pharma SA
3. Address(es) of Site(s)	:	Bedrijvenzone Machelen Cargo 829A, Machelen, 1830, Belgium

4. Legally registered address of Authorisation Holder	:	Rue du Basteau, 5, Forrières, 6953, 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	:	2018-06-14
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: Ibis Pharma SA

, Bedrijvenzone Machelen Cargo 829A, Machelen, 1830, Belgium

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 1.3 Warehouse under the authority of the customs
2.1. Procurement of medicinal products from the European Community (or from the European Economic Space)
3.3 Authorized temperatures : 2-8°C

1.3 Entrepôt placé sous l'autorité des douanes
2.1. Approvisionnement en médicaments via des pays de la Communauté européenne (ou de l'Espace économique européen)
3.3 Températures autorisées : 2-8°C

Reason for Withdrawing:

old

Union Format for a Wholesale Distribution Authorisation	1240 H
	Page 1

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