Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK ManA 28255
2: Name of authorisation holder RUTLAND BIODYNAMICS LIMITED
3: Address(es) of manufacturing site(s)

RUTLAND BIODYNAMICS LIMITED, TOWN PARK FARM, OAKHAM ROAD, BROOKE, OAKHAM, LE15 8DG, UNITED KINGDOM

4: Legally registered address of authorisation holder RUTLAND BIODYNAMICS LIMITED, TOWN PARK FARM, OAKHAM ROAD, BROOKE, OAKHAM, LE15 8DG, 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 08/09/2017
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 1
Name and address of the site:

RUTLAND BIODYNAMICS LIMITED, TOWN PARK FARM, OAKHAM ROAD, BROOKE, OAKHAM, LE15 8DG, UNITED KINGDOM

Veterinary 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. MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Products
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.5 ] Liquids for external use
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.17 ] Other non-sterile medicinal products
            Traditional Herbal products
    [ 1.2.2 ] Batch certification
[ 1.4 ] Other products or manufacturing activity
    [ 1.4.1 ] Manufacture of:
        [ 1.4.1.1 ] Herbal products
        [ 1.4.1.3 ] Other
            Hopguard, Liquid topical ectoparasitic for bees (minor use, minor species)
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.5 ] Liquids for external 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. IMPORTATION OF MEDICINAL PRODUCTS
[ 2.1 ] Quality control testing of imported medicinal products
    [ 2.1.2 ] Microbiological: non-sterility
    [ 2.1.3 ] Chemical/Physical