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Health Products Regulatory Authority

Manufacturer/Importer Authorisation

1. Authorisation Number M20117/00001

2. Name of authorisation holder Orion GMP Consulting Limited (ORG-100050852 / LOC-100088883)

2.1. Alternative name of authorisation holder

3. Address(es) of manufacturing site(s)

Orion GMP Consulting Limited (ORG-100050852 / LOC-100088883), Unit 4, W8 Centre, Church Lane, Manorhamilton, F91 H2YA, Ireland

3.a Additional details on units inspected of manufacturing site(s) address(es)

4. Legally registered address of authorisation holder Unit 4, W8 Centre, Church Lane, Manorhamilton, F91 H2YA, Ireland

4.a Additional details on units inspected of legally registered address

5. Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2

6. Legal Basis of authorisation Art. 40 of Directive 2001/83/EC

7. Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential

8. Signature

9. Date 2025-11-28

10. Annexes attached

Annex 1 and/or Annex 2

Optional Annexes as required:

Annex 3(Addresses of Contract Manufacturing Site(s))

Annex 4(Addresses of Contract laboratories)

Annex 5(Name of Qualified Person)

Annex 6(Name of responsible persons)

Annex 7(Date of inspection on which authorisation granted, scope of last inspection)

Annex 8(Manufactured/ imported products authorised)

SCOPE OF AUTHORISATION ANNEX 1

Name and address of the site :Orion GMP Consulting Limited, Unit 4, W8 Centre, Church Lane, Manorhamilton, F91 H2YA, Ireland

Additional Details:

Human Medicinal Products

Authorised Operations

IMPORTATION OF MEDICINAL PRODUCTS(according to part 2)

Part 2 - IMPORTATION OF MEDICINAL PRODUCTS

2.2  Batch certification of imported medicinal products

   2.2.1  Sterile products
           2.2.1.2  Terminally sterilised

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