New pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament and European Council in December 2010. The legislation was the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of EU marketing authorisations. The European Medicines Agency is responsible for implementing much of the new legislation, which has been effective since July 2012.
The legislation is accompanied by the implementing regulation. This is a legally binding act published by the European Commission in June 2012 that provides details on the operational aspects for the new legislation:
Impacts of the new legislation on marketing-authorisation holders
Marketing-authorisation applicants and holders are impacted by the legislation in a number of key areas. The legislation aims to:
- make roles and responsibilities clear;
- minimise duplication of effort;
- free up resources by rationalising and simplifying periodic safety update reports (PSURs) and adverse-drug-reaction (ADR) reporting;
- establish a clear legal framework for post-authorisation monitoring.
Examples of impacts on marketing authorisation holders and applicants include:
EudraVigilance / ADR reporting
- Following a successful audit, marketing authorisation holders submit ADR reports only into EudraVigilance – previously, reports went via the individual national competent authority. This includes reporting of medication errors that result in an adverse reaction.
Simplified safety monitoring
- PSURs have a single assessment for the same active substance or a combination of active substances.
- Routine PSUR reporting is no longer necessary for products with low risk or for old or established products unless concerns arise.
- PSUR reporting is electronic following the establishment of an EU repository. PSURs are sent directly to the European Medicines Agency.
- There is a strengthened legal basis for requesting post-authorisation safety and efficacy studies (PASSs / PAESs) from the pharmaceutical industry.
- Risk-management systems are required for all newly authorised medicines.
- All pharmacovigilance referrals are discussed by the new Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Opinions will be adopted as a result.
Inspections and pharmacovigilance systems
- Marketing-authorisation holders are required to maintain a pharmacovigilance system master file (PSMF) permanently available for submission or inspection by the national competent authority. The PSMF replaced the detailed description of the pharmacovigilance system (DDPS).
Supply of medicinal product information to the European Medicines Agency
- Regulation 1235/2010 states that by 2 July 2012, marketing-authorisation holders will need to have submitted information to the Agency on medicinal products for human use authorised or registered in the EU using an electronic format provided by the Agency. Marketing-authorisation holders are also responsible for maintaining this information once submitted.
For background information on the legislation and its impacts for the EU public, see 2010 pharmacovigilance legislation.
- Implementation of the pharmacovigilance legislation
- Questions and answers on the implementation of the pharmacovigilance legislation
- Documents for public consultation
- Stakeholder meetings
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- Directive 2010/84/EU
- Regulation (EU) No 1235/2010
- Consolidated version of Directive 2001/83/EU
- Consolidated version of Regulation (EC) No 726/2004
- Commission implementing regulation No 520/2012
- European Commission: Pharmacovigilance - major developments
- 2010 pharmacovigilance legislation: Background information
- New European Union pharmacovigilance legislation – Key concepts (08/02/2013)
- Better vigilance for public health protection - Overview of the new European Union pharmacovigilance legislation (25/03/2013)
- Communication with stakeholders as part of the European Union's new pharmacovigilance legislation (25/03/2013)
- Collection of key information on medicines as part of the European Union's new pharmacovigilance legislation (25/03/2013)
- Better analysis and understanding of data and information as part of the European Union's new pharmacovigilance legislation (25/03/2013)
- Regulatory action to safeguard public health as part of the European Union's new pharmacovigilance legislation (25/03/2013)