The marketing authorisation holders Bio-Tech Solutions Ltd and Mr H.I. & Mrs S.J. Moulds have failed to comply with an improvement notice relating to an inspection of their pharmacovigilance system. They do not have adequate personnel, systems and facilities in place to meet their regulatory requirements for pharmacovigilance.
Veterinary pharmacovigilance is the on-going monitoring of the safety and efficacy of medicines.
The following marketing authorisations have therefore been suspended:
- Johnson’s 4Fleas Powder for Cats and Dogs 1.05% w/w Cutaneous Powder (Vm 20889/4002), Bio-Tech Solutions Ltd
- Armitage Pet Care Flea and Tick Drop for Dogs 702 mg Spot-on Solution (Vm 20205/4003), Mr H.I. Moulds & Mrs S.J. Moulds
- Easi-drop Flea and Tick Drop for Dogs 742 mg Cutaneous Solution (Vm 20205/4000), Mr H.I. Moulds & Mrs S.J. Moulds
Note: These suspensions are not due to any compliance failures by the distributors of the products: Johnson’s, Armitage or Hyperdrug; or any products for which they are marketing authorisation holder.