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RTF Template


Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

W12970/00001

2. Name of Authorisation Holder

:

Immunocore Ireland Limited

(ORG-100032167 / LOC-100051405)

3. Address(es) of Site(s)

:

Unit 1, Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, D17 FY82, Ireland 




4. Legally registered address of Authorisation Holder

:

Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82

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

:

2026-10-15

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: Immunocore Ireland Limited

(ORG-100032167 / LOC-100051405)

, Unit 1, Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, D17 FY82, 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

   3.2. 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):  Restriction: 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,3.3.12 Biological products















Union Format for a Wholesale Distribution Authorisation

W12970/00001


Page 1





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