Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 56952
2: Name of authorisation holder PNR PHARMA CONSULTING LIMITED
3: Address(es) of manufacturing site(s)

PNR PHARMA, UPPER GROUND FLOOR ROOM 2, CREUDDYN, PONTFAEN ROAD, LAMPETER, SA48 7BN, UNITED KINGDOM

PNR PHARMA CONSULTING LTD, UNITS 5 AND 6, LIME AVENUE, EBBW VALE, NP23 6GL, UNITED KINGDOM

4: Legally registered address of authorisation holder PNR PHARMA CONSULTING LIMITED, UNITS 5 AND 6, LIME AVENUE, EBBW VALE, NP23 6GL, UNITED KINGDOM
5: Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2
6: Legal Basis of authorisation
7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential
8: Authorisation Date 09/05/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

PNR PHARMA, UPPER GROUND FLOOR ROOM 2, CREUDDYN, PONTFAEN ROAD, LAMPETER, SA48 7BN, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.3 ] Other Importation Activities
    [ 2.3.4 ] Other
        Importation of QP-certified IMPs from a country on the approved country for import list
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

PNR PHARMA CONSULTING LTD, UNITS 5 AND 6, LIME AVENUE, EBBW VALE, NP23 6GL, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
IMPORTATION OF MEDICINAL PRODUCTS (according to part 2)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.2 ] Batch certification
[ 1.3 ] Biological investigational medicinal products
    [ 1.3.2 ] Batch certification
        [ 1.3.2.1 ] Blood products
        [ 1.3.2.2 ] Immunological products
        [ 1.3.2.3 ] Cell therapy products
        [ 1.3.2.4 ] Gene therapy products
        [ 1.3.2.5 ] Biotechnology products
        [ 1.3.2.6 ] Human or animal extracted products
[ 1.5 ] Packaging
    [ 1.5.2 ] Secondary packaging
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.1 ] Sterile Products
        [ 2.2.1.1 ] Aseptically prepared
        [ 2.2.1.2 ] Terminally sterilised
    [ 2.2.2 ] Non-sterile products
    [ 2.2.3 ] Biological medicinal products
        [ 2.2.3.1 ] Blood products
        [ 2.2.3.2 ] Immunological products
        [ 2.2.3.3 ] Cell therapy products
        [ 2.2.3.4 ] Gene therapy products
        [ 2.2.3.5 ] Biotechnology products
        [ 2.2.3.6 ] Human or animal extracted products
[ 2.3 ] Other Importation Activities
    [ 2.3.1 ] Site of Physical Importation
    [ 2.3.2 ] Importation of Intermediate which undergoes further processing
    [ 2.3.3 ] Biological Active Substance