Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 51381
2: Name of authorisation holder ROYLANCE STABILITY STORAGE LIMITED
3: Address(es) of manufacturing site(s)

ROYLANCE STABILITY STORAGE LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM

4: Legally registered address of authorisation holder ROYLANCE STABILITY STORAGE LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, 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 31/01/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ROYLANCE STABILITY STORAGE LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, 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
[ 2.2 ] 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
        [ 2.2.3.2 ] 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
    [ 2.3.4 ] Other
        Importation of QP certified IMPs from a country on the approved country for import list