Periodic Safety Update Reports (PSURs)

A marketing authorisation holder shall be bound to submit the Periodic Safety Update Reports in accordance with the current valid EURD list, unless it concerns medicinal products authorised according to Section 27, Sub-section 1 or 7 of Act No. 378/2007 Coll., homeopathic products or traditional herbal medicinal products according to Section 30 of Act No.  378/2007 Coll., which are exempt from the submission of the PSUR, unless the EURD list directly imposes the obligation to submit the PSUR for these medicinal products:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/09/news_detail_001616.jsp&mid=WC0b01ac058004d5c1

Unless the medicinal product is entered on the EURD list, the marketing authorisation holder is obliged to submit the PSUR in accordance with the frequency, specified in the marketing authorisation or possibly (if it is not specified therein) in compliance with law, which means: If the medicinal product has not been launched in the market, then at least every 6 months after receiving the marketing authorisation until launching the product in the market. If the medicinal product has already been launched in the market, then at least every 6 months during the first 2 years after the initial launch in the market and afterwards once a year in the following 2 years and subsequently once in 3 years.

Furthermore, a marketing authorisation holder is obliged to submit the PSUR immediately, whenever requested by the Institute.

If a change in the European Union reference date occurs, a marketing authorisation holder of the medicinal product in question shall be bound to immediately file a marketing authorisation variation application lying in the change in the date or frequency of the Periodic Safety Update Report submissions subject to the harmonization set by the agency. The decision on the marketing authorisation variation shall not come into effect before 6 months from the day of the specification of or change in the European Union reference date.

Periodic Safety Update Reports contain data significant for the benefit-risk assessment of  the given medicinal product, including results of all studies, which may influence the marketing authorisation of this medicinal product, scientific benefit-risk evaluation of the given medicinal product, all data relating to the volume of the medicinal product dispensed and sold and all data concerning the volume of prescriptions, which the marketing authorisation holder has at his disposal, including an estimate of the number of people, who have used this medicinal product.

A step by step guide of how to prepare the PSUR can be found on the EMA website - Guideline on Good Pharmacovigilance Practices, Module VII - Periodic Safety Update Report: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c

A marketing authorisation holder shall send the Periodic Safety Update Report to the agency for the first time after the lapse of 12 months from the day, when the Agency communicated the functionality of the Periodic Safety Update Report database. Until then a marketing authorisation holder shall send the report to the Institute and the relevant bodies of all Member States, for which the medicinal product has received marketing authorisation.