![]() The outcome for nationally authorised medicinal products included in 'mixed' procedures where centrally authorised products were also involved can be found on the Community register maintained by the European Commission.įor more information, see Periodic safety update reports: questions and answers. The outcomes of PSUR assessments for active substances found only in centrally authorised medicines are published as part of each medicine's European public assessment report (EPAR). Periodic safety update report single assessments (PSUSAs) - Download table of 4 December 2023įor up to date information, you can search for information on periodic safety update reports via Search.A single assessment of related PSURs is carried out for medicines that contain the same active substance or combination of active substances, as included in the list of EU reference dates (EURD list).ĮMA's scientific committees (PRAC and CHMP) and the CMDh together with the lead Member State assess the information in the related PSURs to determine whether the balance of benefits and risks has changed and whether any updates should be made to the marketing authorisation.ĮMA publishes the lists of nationally authorised medicines involved in PSUR single assessments for active substances contained only in nationally authorised medicines, together with the outcomes of assessments that lead to a variation of marketing authorisations. Post-authorisation summaries of opinionĪ periodic safety update report (PSUR) is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.Initial authorisation summaries of opinion.Pending EC decisions: summaries of opinion for human and veterinary medicines - Download table of 4 December 2023įor up to date information, you can search for medicine information via the pre-filtered search links below:.This summary is replaced by a full European public assessment report once the European Commission has decided - taking the EMA opinion into consideration - whether to grant the marketing authorisation.ĮMA also publishes summaries of opinion when the Committee for Medicinal Products for Human Use (CHMP) or Committee for Veterinary Medicinal Products (CVMP) adopts scientific opinions on important changes to an existing marketing authorisation applied for by the marketing authorisation holder (MAH). Immediately after the opinion is adopted, EMA publishes a 'summary of opinion'. When a pharmaceutical company applies for marketing authorisation through the centralised authorisation procedure, the CHMP or CVMP gives a positive or negative recommendation, in the form of a scientific opinion, on whether a medicine should be authorised.
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