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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W12670/00001
2. Name of Authorisation Holder	:	Athlone Pharmaceuticals Limited (ORG-100004403 / LOC-100084555)
3. Address(es) of Site(s)	:	Maple House, South County Business Park, Dublin 18, D18 F863, Ireland

4. Legally registered address of Authorisation Holder	:	Connaught House, 1 Burlington Road, Dublin 4, D04 C5Y6
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	:	2025-10-10
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: Athlone Pharmaceuticals Limited

(ORG-100004403 / LOC-100053547)

, Maple House, South County Business Park, Dublin 18, D18 F863, 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*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) 3.3.1 Prescription only medicinal products, 3.3.2 Medicinal products for general sale

Any restrictions or clarifying remarks (for all users): 3.3.3 Over the counter medicinal products for sale through pharmacies only
3.3.4 Unauthorised medicinal products
3.3.11 Exempt 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.

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	W12670/00001
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