Federal Agency for Medicines and Health Products
UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION
1. Authorisation Number
:
1810 H
2. Name of Authorisation Holder
Valerco NV
3. Address(es) of Site(s)
Duffelsesteenweg 164b, Kontich, 2550, Belgium
4. Legally registered address of Authorisation Holder
Duffelsesteenweg 164b, KONTICH, 2550, 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
2021-06-25
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: Valerco NV
, Duffelsesteenweg 164b, Kontich, 2550, Belgium
1.1. with a Marketing Authorisation in EEA country(s)
2.1. Procurement
2.2. Holding
2.3. Supply
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): Authorized temperature for the cold chain : 2-8 °C
Toegestane temperatuur voor de koude bewaring : 2-8 °C
Reason for Withdrawing:
due to technical problems, we made a new WDA instead of an update of the old WDA
Union Format for a Wholesale Distribution Authorisation
Page 1
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