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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W11569/00001
2. Name of Authorisation Holder	:	Reckitt Benckiser Ireland Limited (ORG-100001119 / LOC-100100183)
3. Address(es) of Site(s)	:	Ground Floor, 7 River Walk, Citywest Business Campus, Dublin 24, Co. Dublin, D24 H2CE, Ireland

4. Legally registered address of Authorisation Holder	:	6th Floor, 2 Grand Canal Square, Dublin 2, D02 A342
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	:	2026-03-23
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: Reckitt Benckiser Ireland Limited

(ORG-100001119 / LOC-100001574)

, Ground Floor, 7 River Walk, Citywest Business Campus, Dublin 24, Co. Dublin, D24 H2CE, Ireland

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

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

Any restrictions or clarifying remarks (for all users): [1] Without prejudice to further authorisations as may be required according to national legislation.,3.3.02 Medicinal products for general sale,3.3.03 Over the counter medicinal products for sale through pharmacies only

Union Format for a Wholesale Distribution Authorisation	W11569/00001
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