French Public Health Code
In forceI.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety update report containing :
1° All information relating to the benefits and risks associated with this medicinal product or product, including the results of studies which may have an impact on the marketing authorisation;
2° A scientific evaluation of the risk-benefit balance of the medicinal product or product based on all available information, including that resulting from biomedical research for indications and populations not authorised by the marketing authorisation;
3° All information concerning the sale, prescription and population exposed to the medicinal product or product.
The frequency of transmission of the report referred to in the first paragraph is determined in the marketing authorisation. The date of transmission in accordance with this frequency shall be calculated from the date of issue of the marketing authorisation. The European Medicines Agency shall publish a list of reference dates for the European Union and the frequency of submission of periodic safety update reports.
II.Any company or organisation exploiting a medicinal product or a product benefiting from a marketing authorisation granted before 21 July 2012 which is not accompanied by a specific condition mentioned in this authorisation fixing the frequency of submission of the periodic safety update report is required to send this report to the Director General of the Agence nationale de sécurité du médicament et des produits de santé or to the European Medicines Agency:
1° Immediately upon request;
2° Semi-annually:
a) During the period between the granting of the marketing authorisation and the actual placing on the market of the medicinal product or product;
b) During the first two years following the first placing on the market;
3° Annually, for the following two years;
4° Every three years for subsequent years.
These provisions also apply to medicinal products which are authorised only in France and to which the provisions of III below do not apply.
III -Where several medicinal products or several products contain the same active substance or the same combination of active substances or are authorised in several Member States of the European Union or States party to the Agreement on the European Economic Area, the frequency and date of submission of the periodic safety update reports may be modified and harmonised with a view to carrying out a single assessment. This harmonised frequency for the submission of periodic safety update reports shall be made public by the European Medicines Agency. Where appropriate, the marketing authorisation holder submits to the Director General of the Agence nationale de sécurité du médicament et des produits de santé an application to amend its authorisation accordingly. The amendment to the dates and frequency of submission of these reports takes effect six months after the date of publication by the European Medicines Agency.
