Pharmacovigilance Obligations of Marketing Authorisation Holders

Our latest article “Pharmacovigilance Obligations of Marketing Authorisation Holders” by Nihan Bacanak, Zeynep Toma and İrem Deyneli is published on Mondaq.

Human medicinal products are launched to market and made available for public use after going through a set of critical clinical trials, whereas pharmacovigilance aspect plays a crucial role in terms of ensuring the safety of such products in their lifecycle. Pharmacovigilance activities comprise of a wide range including monitoring, registering, assessing and archiving adverse effects of medicinal products and taking necessary measures with a view to minimizing any potential damages.

The piece of legislation that sets forth the main standards and the pharmacovigilance related liability is the Regulation on the Safety of Medicinal products published on the Official Gazette dated 15 April 2014 and numbered 28973 (“Regulation“). Further, with a view to keeping up with the related developments in the EU, the Turkish Medicines and Medical Devices Agency (“Authority“) has also issued a number of guidelines and modules including the Guideline on Pharmacovigilance Indicators, the Guideline on Crisis Management in Pharmacovigilance Activities, the Guidelines on the Protection of Personal Data in Pharmacovigilance Activities and the Guideline on Reliance Applications in Pharmacovigilance Activities.

You may reach the entire article here.