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RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	1842 H
2. Name of Authorisation Holder	:	Van Malderen, Jan (ORG-100035439 / LOC-100056168)
3. Address(es) of Site(s)	:	Prins Albertstraat 20, Sint-Niklaas, 9100, Belgium

4. Legally registered address of Authorisation Holder	:	Prins Albertstraat 20, Sint-Niklaas, 9100
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-08-24
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: Van Malderen, Jan

(ORG-100035439 / LOC-100056168)

, Prins Albertstraat 20, Sint-Niklaas, 9100, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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 Procurement of medicinal products coming from third countries (without physical holding in the European Economic Area (EEA))
3.3 Authorized temperature for the cold chain : 2-8 °C; <-20°C

1.3 Het verkrijgen van geneesmiddelen uit derde landen (zonder fysieke opslag in de Europese Economische Ruimte (EER))
3.3 Toegestane temperatuur voor de koude bewaring : 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

Union Format for a Wholesale Distribution Authorisation	1842 H
	Page 1

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