Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 18024
2: Name of authorisation holder GW PHARMA LIMITED
3: Address(es) of manufacturing site(s)

GW PHARMA LIMITED, UNIT 730, 735, 740, 840, 955, 960 AND 970, KENT SCIENCE PARK, SITTINGBOURNE, ME9 8AG, UNITED KINGDOM

4: Legally registered address of authorisation holder GW PHARMA LIMITED, SOVEREIGN HOUSE, VISION PARK, CHIVERS WAY, HISTON, CAMBRIDGE, CB24 9BZ, 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 09/08/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

GW PHARMA LIMITED, UNIT 730, 735, 740, 840, 955, 960 AND 970, KENT SCIENCE PARK, SITTINGBOURNE, ME9 8AG, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.1 ] Sterile Investigational Medicinal Products
    [ 1.1.3 ] Batch certification
[ 1.2 ] Non-sterile investigational medicinal products
    [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)
        [ 1.2.1.1 ] Capsules, hard shell
        [ 1.2.1.6 ] Liquids for internal use
        [ 1.2.1.15 ] Other non-sterile medicinal products
            Oro-mucosal sprays.
    [ 1.2.2 ] Batch certification
[ 1.5 ] Packaging
    [ 1.5.1 ] Primary packaging
        [ 1.5.1.1 ] Capsules, hard shell
        [ 1.5.1.2 ] Capsules, soft shell
        [ 1.5.1.15 ] Other non-sterile medicinal products
            Oro-mucosal spray
    [ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
    [ 1.6.3 ] Chemical/Physical