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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00421/00001
2. Name of Authorisation Holder	:	Sanofi-Aventis Ireland Limited (ORG-100002310 / LOC-100002758)
3. Address(es) of Site(s)	:	18 River Walk, Citywest Business Campus, Dublin 24, D24 VK33, Ireland

4. Legally registered address of Authorisation Holder	:	18 River Walk, Citywest Business Campus, Dublin 24, D24 VK33
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	:	2026-10-16
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: Sanofi-Aventis Ireland Limited

(ORG-100002310 / LOC-100002758)

, 18 River Walk, Citywest Business Campus, Dublin 24, D24 VK33, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) N/A

Any restrictions or clarifying remarks (for all users): Not all of the contract storage sites listed in Annex 2 are authorised to hold all of the categories of medicinal products listed in Annex 1. [1] Without prejudice to further authorisation sas may be required according to national legislation. ,3.3.01 Prescription only medicinal products,3.3.02 Medicinal products for general sale,3.3.03 Over the counter medicinal products for sale through pharmacies only,3.3.05 Vaccines,3.3.06 Parallel imported medicinal products authorised by Parallel Product Authorisation (PPA),3.3.11 Exempt medicinal products,3.3.12 Biological products,3.3.04 Unauthorised medicinal products,3.3.16 Immunological medicinal products

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	W00421/00001
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