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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W11027/00001
2. Name of Authorisation Holder	:	Thera Pharmaceuticals Limited (ORG-100019625 / LOC-100028383)
3. Address(es) of Site(s)	:	Unit 4, Besser Drive, Clondalkin Industrial Estate, Dublin 22, D22 HW86, Ireland

4. Legally registered address of Authorisation Holder	:	Unit 4, Besser Drive, Clondalkin Industrial Estate, Dublin 22, D22 HW86
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	:	2025-07-21
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: Thera Pharmaceuticals Limited

(ORG-100019625 / LOC-100028383)

, Unit 4, Besser Drive, Clondalkin Industrial Estate, Dublin 22, D22 HW86, 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

2.2. Holding

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) Please see restrictions or clarifying remarks (for all users).

Any restrictions or clarifying remarks (for all users): 3.3.1 Prescription only medicinal products3.3.2 Medicinal products for general sale3.3.3 Over the counter medicinal products for sale through pharmacies only3.3.4 Unauthorised medicinal products3.3.5 Vaccines3.3.6 Parallel imported medicinal products authorised by Parallel Product Authorisation (PPA)3.3.7 Parallel imported medicinal product authorised by Dual Pack Registration (DPR)3.3.8 Parallel distributed centrally authorised medicinal products3.3.9 Traditional herbal medicinal products3.3.10 Homeopathic medicinal products registered under the Simplified Registration Scheme3.3.11 Homeopathic medicinal products authorised under the National Rules Scheme3.3.12 Exempt medicinal products3.3.13 Biological products3.3.14 Advance Therapeutic Medicinal products3.3.16 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	W11027/00001
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