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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-06-11

RTF Template

Federal Agency For Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	1495 H
2. Name of Authorisation Holder	:	Prochiphar (ORG-100016382 / LOC-100025166)
3. Address(es) of Site(s)	:	Rue Bois Des Queues 9, Incourt, 1315, Belgium

4. Legally registered address of Authorisation Holder	:	Rue Bois Des Queues 9, Pietrebais, 1315
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	:	2023-04-19
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: Prochiphar S.A.

(ORG-100016382 / LOC-100025166)

, Rue Bois Des Queues 9, Incourt, 1315, Belgium

Human medicinal products

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

2.3. Supply

2.4. Export

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): 1.3 : warehouse under the authority of the customs.
3.3 : Authorized temperature for the cold chain : 2-8 °C

1.3 : entrepôt placé sous l'autorité des douanes.
3.3 : Température autorisée pour la chaîne du froid : 2-8°C

Reason for Withdrawing:

withdrawn due to a inspector note

Union Format for a Wholesale Distribution Authorisation	1495 H
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