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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	:	624 H
2. Name of Authorisation Holder	:	AstraZeneca (ORG-100000002 / LOC-100043806)
2.a. Alternative name of authorisation holder (optional)	:	AstraZeneca N.V.
3. Address(es) of Site(s)	:	Groot Bijgaarden, Alfons Gossetlaan 40 Bus 201, Dilbeek, 1702, Belgium

4. Legally registered address of Authorisation Holder	:	Groot Bijgaarden, Alfons Gossetlaan 40 Bus 201, Dilbeek, 1702
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	:	2025-06-01
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: AstraZeneca

(ORG-100000002 / LOC-100043806)

, Groot Bijgaarden, Alfons Gossetlaan 40 Bus 201, Dilbeek, 1702, Belgium

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Union Format for a Wholesale Distribution Authorisation	624 H
	Page 1

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