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    Submission of safety variations following signal and PSUR assessment outcome

    28.04.2017
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    Signal assessment outcome – submission of safety variations

    The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for the analysis, prioritisation and assessment of validated signals, resulting in a PRAC recommendation.

    More information: Signal management

    The EMA publishes PRAC recommendations every month under: PRAC recommendations on safety signals

    You can find the Excel table at the bottom of the page (List of safety signals discussed since September 2012), where list of all signals discussed at PRAC is published. Last column of the table (Update of product information recommended by PRAC) contains information whether Product Information has to be updated or not (No/Yes). In the second column from the right (PRAC meeting) the date of PRAC meeting and link to the PRAC protocol is given (NB! You cannot find the updated wording of the Product Information there). To find the Product Information updated wording, you should go one step backwards, where Excel table is at the bottom of the page and pdf files of PRAC Recommendations on adopted signals can be found (PRAC recommendations on safety signals: monthly overviews). You should choose the pdf file „New product information wording” with the date and year given in the Excel table and choose ET= Eesti keel language.  

    NB! In preparing the variation the translation given in PRAC recommendations should be used.
     

    Periodic Safety Update report (PSUR) assessment outcome - submission of safety variations

    Depending on whether the PSUSA (Periodic safety update report single assessments) involved only centrally authorised, centrally and nationally, only nationally authorised active substances or whether the active substance is included in the EURD list (List of European Union reference dates) or it not (yet) included there the outcomes of PSUR assessments are published on different websites:

    More information: Periodic safety update report single assessments

    1. PSUSA procedure involves only centrally authorised products

    The outcomes of PSUR assessments are published as part of each medicine's EPAR: European public assessment report

    2. PSUSA procedure involves both centrally and nationally authorised products

    The outcome can be found on the Community Register maintained by the European Commission.

    3. PSUSA procedure involves only nationally authorised products

    The outcomes of the PSUR single assessments are published on EMA website „Outcomes of periodic safety update report single assessments

    In the second column from the right (Regulatory outcome) it is stated whether variation has to be submitted or not (Variation/Maintenance) following PSUR single assessment. In case variation has to be submitted in the last column named “Documents” you can find in addition to the list of medicines the pdf file named “CMDh scientific conclusions ...”, where you can find the conclusion and updated wording also in Estonian language. Product information must be updated according to this document.

    NB! In preparing the variation the translation given in CMDh conclusion should be used.

    4. Active substance is not in the EURD list and PSUR assessment is carried out within Work-sharing (WS) procedure

    Following CMDh monthly meeting the outcomes of informal PSUR WS procedures are published on CMDh website.

    Summaries of PSUR Assessment Reports are published on CMDh website Pharmacovigilance site

    Updates of Product Information are given in the Assessment Report. Marketing Authorisation Holder (MAH) has to organise the translation of the Product Information.

    MAH should make sure (even if the active substance is in the EURD list), that all Product Information updates published on CMDh website in the list of active substances are implemented into Product Information. Usually the timetable of implementation is provided within the CMDh press release.