Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 427
2: Name of authorisation holder ROSEMONT PHARMACEUTICALS LIMITED
3: Address(es) of manufacturing site(s)

ROSEMONT PHARMACEUTICALS LIMITED, ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, LS11 9XE, UNITED KINGDOM

4: Legally registered address of authorisation holder ROSEMONT PHARMACEUTICALS LIMITED, ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, LS11 9XE, 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 15/05/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

ROSEMONT PHARMACEUTICALS LIMITED, ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS, LS11 9XE, 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
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.8 ] Other solid dosage forms
        [ 1.2.1.13 ] Tablets
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.6 ] Liquids for internal use
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.2 ] Microbiological: non-sterility
    [ 1.6.3 ] Chemical/Physical
Part 2 - IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.2 ] Microbiological: non-sterility
    [ 2.1.3 ] Chemical/Physical
[ 2.2 ] Batch certification of imported medicinal products
    [ 2.2.2 ] Non-sterile products