According to European Medicaments Agency (EMA) guidelines, already implemented since 2012; Marketing Authorization Holders (MAHs) have to submit periodic updated safety reports following GVP Module VII.
The objective of this submission is to harmonise all the existing information relating to every single medicinal product; in order to update their risk-benefit profile. This strategy allows EMA to get a huge data base with all the information and to stablish early measures when they identify any risk.
Depending on the marketing stage of the medicinal product; Marketing Authorization Holders have to prepare these PBRER on different times. From authorization to marketing stage; MAH has to submit it every 6 months. Then, PSURs have to be sent every six months during the first two years. Later PSURs’ submission is annually until medicinal product has been four years on the market, and MAHs have to submit PSURs once every three years.
You can find below all the different stages when marketing a medicinal product and EMA’s submission deadlines.
Anyway, EMA can demand a submission of a PBRER anytime, and MAH has to prepare it immediately.
In order to harmonise all the information, EMA establish EU reference dates list to receive all the PBRERs referred to the same active substance or combination of substances at the same time. EMA prepares this reference dates list defining periodicity on a risk-based approach.
EU reference dates list is a living document that can be amended whenever considered necessary by the PRAC, the CHMP or CMDh. They can introduce or remove any substance according with safety profile information.
Generic drug and traditional herbal products are exempted from submitting PBRERs unless the MAH has submitting PBRERs as a marketing condition or when the herbal medicine has been out of market a long time and there is a lack of safety information. However, MAH of these kind of products have to evaluate the safety profile of the substance, and submit any relevant information when they find it.
There is a special sort of PSURs defined as PSUSA. PSUSA is a PSUR single assessment of substances contained in centrally authorised product(s) and nationally authorised products. This assessment leads to legally binding outcomes: maintenance, variation, suspension, revocation of the marketing authorisation. PSUSA is prepared in order to enhance the safety and benefit-risk profile of a substance.
EMA can harmonise all the related information through this reports, guaranteeing health and safety of all European population.
In Azierta we are safety experts, and we are able to deliver any kind of safety report. We have done more than 400 reports worldwide, helping companies to ensure safety and risk-benefit of its medicinal products.
