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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-09-09

RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	1753 H
2. Name of Authorisation Holder	:	BePharBel Manufacturing SA
3. Address(es) of Site(s)	:	Rue du Luxembourg, 13, Courcelles, B-6180, Belgium

4. Legally registered address of Authorisation Holder	:	Rue du Luxembourg, 13, Courcelles, 6180, Belgium
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-09-16
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: BePharBel Manufacturing SA

, Rue du Luxembourg, 13, Courcelles, B-6180, Belgium

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

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): 2.1 IC In : 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 IC In: Egalement acquisition de médicaments via d'autres pays de l'Espace économique européen (EEE) que la Belgique.

3.3 Température autorisée pour la chaîne du froid : 2-8 °C

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Reason for Withdrawing:

old

Union Format for a Wholesale Distribution Authorisation	1753 H
	Page 1

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