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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W11361/00001
2. Name of Authorisation Holder	:	Horizon Therapeutics Ireland Designated Activity Company (ORG-100001903 / LOC-100094036)
3. Address(es) of Site(s)	:	Pottery Road, Dun Laoghaire, Dublin, A96 F2A8, Ireland

4. Legally registered address of Authorisation Holder	:	Pottery Road, Dun Laoghaire, Dublin, A96 F2A8
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	:	2026-09-02
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: Horizon Therapeutics Ireland Designated Activity Company

(ORG-100001903 / LOC-100094036)

, Pottery Road, Dun Laoghaire, Dublin, A96 F2A8, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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): [1] Without prejudice to further authorisations as may be required according to national legislation.,3.3.04 Unauthorised medicinal products,3.3.12 Biological products,3.3.01 Prescription only medicinal products

Union Format for a Wholesale Distribution Authorisation	W11361/00001
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