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.

As per the above referred legislation and guidelines, the main obligations of marketing authorisation holders ("MAH"s) in Turkey are as follows:

  • Establishment of a pharmacovigilance system. MAHs should establish a system to monitor the safety of medicinal products and to detect any changes in their benefit / risk balances. Through this system, MAHs should be able to evaluate the pharmacovigilance data and take the necessary measures to minimize and prevent the risks associated with the products. The system can be operated by either appointing a pharmacovigilance officer or through a contracted pharmacovigilance service provider.
  • Appointment of an officer or contracting with a pharmacovigilance service provider. MAHs may appoint a doctor or a pharmacist as a qualified pharmacovigilance officer, who will be responsible for operating and maintaining the pharmacovigilance system. Appointed pharmacovigilance officers may not simultaneously hold marketing or sales positions. As an alternative to appointing a pharmacovigilance officer, MAHs may outsource the establishment and maintenance of the pharmacovigilance system to an organisation accredited by the Authority. This, however, does not relieve MAHs from the related liability.
  • Maintaining pharmacovigilance system master file. Maintaining a file including detailed description of pharmacovigilance system is also an obligation imposed on MAHs under the Regulation. The file should contain, among others, information regarding the pharmacovigilance officer and their responsibilities, organizational structure of the MAH, data in relation to handling and recording processes and periodic risk-benefit assessment reports. The master file must also be updated regularly to reflect the most up-to-date information.
  • Continuous review. MAHs should regularly monitor the pharmacovigilance data to determine if there have been any changes in the known and/or potential risks associated with the medicinal product or benefit/risk balances. In case of any changes, the Authority should be notified.
  • Notification of adverse reactions. The Regulation requires MAHs to report all suspected serious adverse reactions that occur in Turkey to the Turkish Pharmacovigilance Center ("TUFAM") within 15 days upon becoming aware of the circumstances. TUFAM should also be notified of the reports received from other countries where the product is marketed. Further, MAHs should include a standard text in the instructions for use of medicinal product explaining that consumers and/or healthcare professionals should report any suspected adverse reactions to TUFAM.
  • Compliance with data protection obligations. MAHs collect data while performing pharmacovigilance activities, which, as mentioned above, involve reporting suspected adverse reactions. Such data often includes special categories of personal data of reporters. The Authority has determined the principles on the protection of the pharmacovigilance data under the Guidelines on the Protection of Personal Data in Pharmacovigilance Activities dated 1 August 2019. Accordingly, the identity and the address of reporters should be kept confidential, and should not be revealed to a third party other than TUFAM personnel without the consent of the reporter.

Compliance with pharmacovigilance legislation is monitored by TUFAM and the Authority. TUFAM collects and records pharmacovigilance notifications and liaises with the World Health Organization Uppsala Monitoring Center in this regard. Further, TUFAM informs other international organisations and MAHs and other international organisations of recent pharmacovigilance studies, and offers fundamental pharmacovigilance training programs. The Authority, on the other hand, conducts inspections and investigations to ensure compliance with the pharmacovigilance requirements. In case of detection of non-compliance, the Authority may grant the MAH a remedy period. In case of failure to rectify the non-compliance within the granted period, sanctions which include prevention of supply of the product or suspension or cancellation of the licence may be imposed depending on the severity of the non-compliance.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.