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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W12073/00001
2. Name of Authorisation Holder	:	Lxo Ireland Designated Activity Company (ORG-100007668 / LOC-100011579)
3. Address(es) of Site(s)	:	D'Olier Chambers, 16a D'Olier Street, Dublin 2, Co. Dublin, D02 H589, Ireland

4. Legally registered address of Authorisation Holder	:	D'Olier Chambers, 16a D'Olier Street, Dublin 2, Co. Dublin, D02 H589
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	:	2026-01-05
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: Lxo Ireland Designated Activity Company

(ORG-100007668 / LOC-100011579)

, D'Olier Chambers, 16a D'Olier Street, Dublin 2, Co. Dublin, D02 H589, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

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

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

Any restrictions or clarifying remarks (for all users): Not all of the contract wholesale distribution sites listed in Annex 2 are appropriately authorised to hold all of the medicinal product categories listed in Annex 1.,3.3.01 Prescription only medicinal products,3.3.04 Unauthorised medicinal products

Union Format for a Wholesale Distribution Authorisation	W12073/00001
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