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Pharmacovigilance

Monitoring

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

Within the framework of the EU pharmacovigilance system, the European Medicines Agency (EMA) coordinates member states' activities in connection with monitoring the safety of medicines placed on the EU market. Suspected adverse reactions must be entered in the online EudraVigilance information system managed by the EMA. The reporting of suspected adverse reaction in EudraVigilance is obligatory for marketing authorisation holders and national competent authorities.

The EMA Pharmacovigilance Risk Assessment Committee evaluates signals from EudraVigilance and may recommend regulatory actions as a result. If the EMA is concerned that the risk-benefit profile of a medicinal product has varied, it can adopt an opinion advising that the medicinal product’s marketing authorisation be varied and requiring the marketing authorisation holder to conduct post-authorisation safety studies. The opinion is then submitted to the European Commission for approval.

Data protection

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

The EMA Guideline on Good Pharmacovigilance Practices (EMA/541760/2011) provides that the fundamental right to personal data protection must be fully and effectively guaranteed in all pharmacovigilance activities. As part of a record management system, specific measures should be taken at each stage of the storage and processing of pharmacovigilance data to ensure data security and confidentiality. This should involve the strict limitation of access to documents and databases to authorised personnel respecting the medical and administrative confidentiality of the data.

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