The Human Medicines Regulations 2012

Obligation on holder to operate pharmacovigilance system

182.—(1) The holder must operate a pharmacovigilance system.

(2) The holder must (as part of its pharmacovigilance system)—

(a) have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance who resides and operates in the EU and is responsible for the establishment and maintenance of the pharmacovigilance system;

(b) maintain and make available on the request of the licensing authority a pharmacovigilance system master file;

(c) operate a risk management system for the product in accordance with the risk management plan (if any) for the product (subject to regulation 183);

(d) monitor the outcome of the risk minimisation measures which are contained in the risk management plan (if any) for the product or which are laid down as conditions of the authorisation of the product under regulations 59 to 61 (conditions of UK marketing authorisation); and

(e) update the risk management system for the product and monitor pharmacovigilance data to determine whether in relation to the product—

(i) there are new risks,

(ii) risks have changed, or

(iii) there are changes to the risk-benefit balance.

(3) The holder must keep the licensing authority and the EMA informed of the name and contact details of the appropriately qualified person mentioned in paragraph (2)(a) at all times.

(4) The holder must use its pharmacovigilance system to—

(a) evaluate scientifically all information relevant to the product;

(b) consider options for minimising and preventing the risk presented by the use of the product; and

(c) take appropriate measures as soon as is reasonably practicable to—

(i) investigate the potential risks of the product,

(ii) communicate the risks, and

(iii) implement actions for minimising and preventing the risks, including updating the risk management system for the product.

(5) Where the licensing authority requests that the pharmacovigilance system master file is made available under paragraph (2)(b), the holder must submit a copy of the pharmacovigilance system master file to the licensing authority before the end of the period of 7 days beginning on the day after the day when the request was made.

(6) This regulation is subject to regulation 212 (transitional arrangements).