Medicines and Healthcare products Regulatory Agency

MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 6180
2: Name of authorisation holder SYNERGY HEALTH STERILISATION UK LIMITED
3: Address(es) of manufacturing site(s)

SYNERGY HEALTH STERILISATION UK LIMITED , MORAY ROAD, ELGIN INDUSTRIAL ESTATE, SWINDON, SN2 8XS, UNITED KINGDOM

SYNERGY HEALTH STERILISATION UK LIMITED , BRUNEL CLOSE, DRAYTON FIELDS INDUSTRIAL ESTATE, DAVENTRY, NN11 8RB, UNITED KINGDOM

SYNERGY HEALTH STERILISATION UK LIMITED, ROYDSDALE WAY, EUROWAY TRADING ESTATE, BRADFORD, BD4 6SE, UNITED KINGDOM

4: Legally registered address of authorisation holder SYNERGY HEALTH STERILISATION UK LIMITED, RENAISSANCE HOUSE, 2200, BASING VIEW, BASINGSTOKE, RG21 4EQ, 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 07/11/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

SYNERGY HEALTH STERILISATION UK LIMITED , MORAY ROAD, ELGIN INDUSTRIAL ESTATE, SWINDON, SN2 8XS, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.5 ] Gamma irradiation
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

SYNERGY HEALTH STERILISATION UK LIMITED , BRUNEL CLOSE, DRAYTON FIELDS INDUSTRIAL ESTATE, DAVENTRY, NN11 8RB, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.5 ] Gamma irradiation
        [ 1.4.2.6 ] Electron beam
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:

SYNERGY HEALTH STERILISATION UK LIMITED, ROYDSDALE WAY, EUROWAY TRADING ESTATE, BRADFORD, BD4 6SE, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.4 ] Other investigational medicinal products or manufacturing activitiy
    [ 1.4.2 ] Sterilisation of active substances/excipients/finished products:
        [ 1.4.2.5 ] Gamma irradiation