Pharmacovigilance Inspections

In accordance with Law 70(I)/2001, the Drugs Council implements a pharmacovigilance system for the fulfillment of pharmacovigilance requirements.

A similar and equivalent pharmacovigilance system is required to be implemented by all Marketing Authorisation Holders (MAH) in Cyprus in order to meet the requirements arising from the Legislation.

Within the framework of the Pharmacovigilance System and in accordance with article 57 of the Law, the MAH is obliged, among other things, to:

· Permanently and continuously have a suitably qualified person responsible for pharmacovigilance (QPPV)

· Maintain and have at his/her disposal, when requested, the Pharmacovigilance System Master File (PSMF)

· Implement a risk management system for each pharmaceutical product

· Scientifically evaluate all information regarding pharmaceutical products

· Examine and takes measures (where required) to minimise and prevent risks

· Check the pharmacovigilance system at regular intervals

· Follow and comply with the provisions of the legislation (European and National) and the guidelines as amended from time to time.

Pharmacovigilance inspections are intended to regulate the obligation of the MAH or the Local Representative to maintain and implement a pharmacovigilance system and to comply with the provisions of Law 70 (I) / 2001 on pharmacovigilance, as well as guidelines, instructions, procedures, regulations, decrees, contracts or other requirements.