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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

Marketing authorisation holders are required to keep records of all side effects signalled either by patients or by healthcare professionals, no matter whether they showed up in the European Union or non-EU countries. Holders are also required to convey such data to the Eudravigilance database within 90 days of receiving it.

Holders are also required to submit periodic reports to the European Medicines Agency containing information related to their pharmacovigilance obligations. In certain circumstances they may be required by the National Agency for Medicines and Medical Devices to conduct post-authorisation studies on the medicine’s safety or efficacy.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

No specific data protection regulation with regard to pharmacovigilance activities has been adopted by the Ministry of Health or the National Agency for Medicines and Medical Devices so far.

Consequently, all pharmacovigilance activities must be performed according to the Personal Data Processing Law (677/2001). This states that personal data concerning health is considered sensitive and cannot be processed without the data subject’s express consent.

Personal data regarding health may be processed only by or under the supervision of health professionals under the condition of professional secrecy.

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