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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W11879/00001
2. Name of Authorisation Holder	:	Swords Laboratories Unlimited Company (ORG-100011785 / LOC-100019585)
3. Address(es) of Site(s)	:	Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

4. Legally registered address of Authorisation Holder	:	Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867
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	:	2026-05-05
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: Swords Laboratories Unlimited Company

(ORG-100011785 / LOC-100019585)

, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, 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

2.3. 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): 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. The geographic address of the contract wholesale distribution site by the name of SwordsLaboratories Limited Company T/A Lawrence Laboratories is Unit 12 & 15 Distribution Centre, Shannon Industrial EstateShannon, Co. Clare, V14 DD39, Ireland. , ,3.3.01 Prescription only medicinal products,3.3.02 Medicinal products for general sale,3.3.04 Unauthorised medicinal products,3.3.12 Biological 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.

Union Format for a Wholesale Distribution Authorisation	W11879/00001
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