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RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00011/00001
2. Name of Authorisation Holder	:	Irish Blood Transfusion Service (ORG-100018210 / LOC-100026999)
3. Address(es) of Site(s)	:	National Blood Centre, James's Street, Dublin 8, D08 NH5R, 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-100026999)

, National Blood Centre, James's Street, Dublin 8, D08 NH5R, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

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

Union Format for a Wholesale Distribution Authorisation	W00011/00001
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