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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00241/00001
2. Name of Authorisation Holder	:	Uniphar Wholesale Limited (ORG-100035608 / LOC-100056403)
3. Address(es) of Site(s)	:	4045 Kingswood Drive, Citywest Business Campus, Dublin 24, D24 V06K, Ireland

4. Legally registered address of Authorisation Holder	:	4045 Kingswood Drive, Citywest Business Campus, Dublin 24, D24 V06K
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	:	2026-06-24
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: Uniphar Wholesale Limited

(ORG-100035608 / LOC-100056403)

, 4045 Kingswood Drive, Citywest Business Campus, Dublin 24, D24 V06K, 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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

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

Any restrictions or clarifying remarks (for all users): The geographic address of the legally registered address and wholesaling site for Uniphar Wholesale Limited is 4045 Kingswood Road, Citywest Business Park, Dublin, Ireland. [1] Without prejudice to further authorisations as 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,3.3.04 Unauthorised medicinal products,3.3.05 Vaccines,3.3.06 Parallel imported medicinal products authorised by Parallel Product Authorisation (PPA),3.3.07 Parallel imported medicinal product authorised by Dual Pack Registration (DPR),3.3.08 Parallel distributed centrally authorised medicinal products,3.3.09 Traditional herbal medicinal products,3.3.10 Homeopathic medicinal products (HOR and HOA),3.3.11 Exempt medicinal products,3.3.12 Biological products,3.3.14 Medicinal Gases,3.3.15 Medicinal products derived from blood,3.3.16 Immunological medicinal products,3.3.17 Radiopharmaceuticals (including radionuclide kits)

*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	W00241/00001
	Page 1

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