National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014 (S.I. No. 37 of 2014).

These Regulations, made by the Minister responsible for health under section 64 of the National Drug Policy and Authority Act, and on the advice of the National Drug Authority, provide with respect to a pharmacovigilance system and the reporting of and investigation of counterfeit drugs. “Pharmacovilance” means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem. A licensed person shall have an appropriate system for pharmacovigilance, to manage the safety of the data for the drugs for which the licensed person is responsible. Where the National Drugs Authority determines that a drug may not be safe to use, the Authority shall request a licensed person to submit to the Authority— (a) a periodic safety update report; and (b) any other reports that may be relevant to determine the safety, efficacy and quality of the drug, as the Authority may determine. A report shall be submitted using the format in the Schedule to these Regulations, for human drugs or veterinary drugs, respectively.