Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 34777
2: Name of authorisation holder AVIDA MEDICAL LIMITED
3: Address(es) of manufacturing site(s)

AVIDA MEDICAL LIMITED, N T U MEDICAL TECHNOLOGIES INNOVATION FACILITY, FIRST AVENUE, BEESTON, NOTTINGHAM, NG9 1BG, UNITED KINGDOM

4: Legally registered address of authorisation holder AVIDA MEDICAL LIMITED, UNIT 2A, GENESIS HOUSE, MERROW LANE, GUILDFORD, GU4 7BN, 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 27/06/2024
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

AVIDA MEDICAL LIMITED, N T U MEDICAL TECHNOLOGIES INNOVATION FACILITY, FIRST AVENUE, BEESTON, NOTTINGHAM, NG9 1BG, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
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)
        [ 1.2.1.1 ] Capsules, hard shell
            Special Requirements
            Products may have corticosteroids/hormones as an active ingredient
        [ 1.2.1.5 ] Liquids for external use
            Special Requirements
            Products may have corticosteroids/hormones as an active ingredient
        [ 1.2.1.6 ] Liquids for internal use
            Special Requirements
            Products may have corticosteroids/hormones as an active ingredient
        [ 1.2.1.8 ] Other solid dosage forms
            Special Requirements
            Products may have corticosteroids/hormones as an active ingredient
        [ 1.2.1.11 ] Semi-solids
            Special Requirements
            Products may have corticosteroids/hormones as an active ingredient
        [ 1.2.1.12 ] Suppositories
Special Requirements
            Products may have corticosteroids/hormones as an active ingredient
        [ 1.2.1.15 ] Other non-sterile medicinal products
            Powders
    [ 1.2.2 ] Batch certification
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.1 ] Herbal products
        [ 1.4.1.3 ] Other
            Products may have corticosteroids/hormones as an active ingredient
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.5 ] Liquids for external use
        [ 1.5.1.6 ] Liquids for internal use
        [ 1.5.1.8 ] Other solid dosage forms
        [ 1.5.1.11 ] Semi-solids
        [ 1.5.1.12 ] Suppositories
        [ 1.5.1.15 ] Other non-sterile medicinal products
            Powders
    [ 1.5.2 ] Secondary packaging