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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?

In France, pharmacovigilance procedures aim to monitor, evaluate, prevent and manage the risk of an adverse reaction resulting from the use of medicinal products (Article L5121-22 of the Public Health Code). Pharmacovigilance involves the reporting of suspected medicinal product-related adverse reactions, including in case of overdose, misuse, abuse and medication errors (Article R5121-150 of the Public Health Code).

Pharmacovigilance is coordinated between the National Agency for Medicines and Health Products Safety (ANSM), regional pharmacovigilance centres, healthcare practitioners and pharmaceutical companies. The latter have an obligation to collect and assess information relating to adverse effects, with a view to prevent and mitigate risks and must, if necessary, take appropriate measures (Article L5121-24 of the Public Health Code). 

Data protection

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

According to the data protection law, when implementing a pharmacovigilance system, companies must file a notification with the National Commission on Informatics and Civil Liberties (CNIL) before carrying out any data processing operations. In order to simplify the standard procedures, the CNIL issued the unique authorisation procedure (AU-013) on March 20 2014, which can be used for data processing relating to pharmacovigilance and is less cumbersome and time consuming for companies. 

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