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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00011/00002
2. Name of Authorisation Holder	:	Irish Blood Transfusion Service (ORG-100018210 / LOC-100026999)
3. Address(es) of Site(s)	:	Munster Regional Transfusion Centre, Saint Finbarr's Hospital, Douglas Road, Cork, T12 Y319, Ireland

4. Legally registered address of Authorisation Holder	:	National Blood Centre, James's Street, Dublin 8, D08 NH5R
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: Irish Blood Transfusion Service

(ORG-100018210 / LOC-100041990)

, Munster Regional Transfusion Centre, Saint Finbarr's Hospital, Douglas Road, Cork, T12 Y319, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) Temperatures below 0 degrees celsius

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,3.3.01 Prescription only medicinal products,3.3.12 Biological products,3.3.15 Medicinal products derived from blood

Union Format for a Wholesale Distribution Authorisation	W00011/00002
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