Collection of key information on medicines Risk-management plans The pharmacovigilance legislation strengthened procedures concerning risk-management plans. This includes requiring a risk-management plan for all new medicines and the publication of summaries of risk-management plans, which the Agency began in March Risk-management plans ensure that proactive planning of data collection and of risk minimisation takes place. They are essential for the safe introduction of new products for patients.
In cases of Marketing authorization via the mutual recognition or decentralized procedures, the Competent Authority of the Member State and of the Reference member State should be consulted.
The Safety Specifications is intended to help industry and regulators identify any need for specific data collection and also to facilitate the construction of the Parmacovigilance Plan. Safety Specification should consist of: There is a Routine Pharmacovigilance Plan and an Additional Plan for medicinal products with important identified risks, important potential risk and important missing information.
Some safety concerns may be adequately addressed by the proposed actions in the Pharmacovigilance Plan, but for others the risk may be of a particular nature and seriousness that risk minimization activities are needed. For some risks, routine risk minimization activities will not be sufficient and additional risk minimization activities will be necessary.
Expedited Reporting of Individual Case Safety Reports The MAH is expected to validate all adverse reactions reported by Healthcare Professionals to ensure, prior to reporting to the competent Authorities, that the minimum information required is included in the report: Other sources for adverse reactions should be reports published in the worldwide literature, internet, data collection systems clinical studies, post-authorization studies, management disease programs, information about patients compliance.
Electronic reporting by Eudravigilance is a must. In addition to routine expedited and periodic reporting requirement the MAH should be aware of the following additional reporting requirement relating to world wide experience with the medicinal product: At these times, MAHs are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in the light of new changing information.
This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the marketing authorization and product information.
For a PSUR that spans longer time intervals, e. Submission of PSURs for Renewal of marketing Authorization The MAH should submit safety data with renewal application at least 6 months before the expiry date of the marketing authorization in the EU; the MAH should lock the data no more than 60 days before submitting the PSUR Circumstances where the periodicity may be amended less frequent submission:EudraBook V1 - May / EudraLex V30 - January Overview.
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing .
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and.
Nov 17, · New EU Pharmacovigilance Legislation. The 15 new EU modules concerning Pharmacovigilance are a major departure in terms of the way Pharmacovigilance is conducted in Europe.
high-level organization chart providing an overview of the global and EEA pharmacovigilance units and organizations and illustrating the relationships between them flow diagrams indicating the flow of safety reports and how are process and reported from the sources to the point of receipt by the Competent Authorities.
The pharmacovigilance legislation, which came into effect in , introduced a range of tasks and streamlined existing responsibilities for regulators and the pharmaceutical industry in . The regulation complements new EU pharmacovigilance legislation adopted in and , by specifying the situations in which post-authorisation efficacy studies are required.
The text of the Delegated Regulation is available here.