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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-11-08

RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	1382 H
2. Name of Authorisation Holder	:	Baxter Distribution Center Europe sa
3. Address(es) of Site(s)	:	Chemin de Papignies 17B, Lessines, 7860, Belgium

4. Legally registered address of Authorisation Holder	:	Chemin de Papignies, 17B, Lessines, 7860, 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	:	2020-11-13
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: Baxter Distribution Center Europe SA

, Chemin de Papignies 17B, Lessines, 7860, 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

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

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; -20 °C

3.3. Température autorisée pour la chaîne du froid : (2-8)°C; -20 °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	1382 H
	Page 1

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