The Pharmacovigilance Implementing Measures, is the new pharmacovigilance legislation which came into effect in 2012. It introduced a range of new responsibilities for regulators and the pharmaceutical industry in the European Union (EU) concerning the Identification of Medicinal Products (IDMP).
The activities introduced with the pharmacovigilance legislation fall into four main areas:
- Collection of key information on medicines
- Analysis and understanding of data and information
- Regulatory action to safeguard public health
- Communicating with stakeholders
Data submission for authorised medicines
The legislation requires marketing-authorisation holders to submit structured electronic information to the Agency on medicines authorised in the European Union (EU) and European Economic Area (EEA).
This will ensure that the pharmacovigilance systems for the Agency, national competent authorities and industry are driven by accurate, complete and reliable information on medicines, substances and organisations.
Article 26(2) of the Pharmacovigilance Implementing Measures
26(2) For the purpose of paragraph 1 national competent authorities, marketing authorisation holders and the Agency may also apply the following formats and standards:
(a) EN ISO 27953-2:2011 Health Informatics, Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011);
(b) EN ISO 11615:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of regulated medicinal product information’ (ISO/FDIS 11615:2012);
(c) EN ISO 11616:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard ‘Data elements and structures for unique identification and exchange of regulated pharmaceutical product information’ (ISO/FDIS 11616:2012);
(d) EN ISO 11238:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of regulated information on substances’ (ISO/FDIS 11238:2012);
(e) EN ISO 11239:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation and routes of administration’ (ISO/FDIS 11239:2012);
(f) EN ISO 11240:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of units of measurement’ (ISO/FDIS 11240:2012)
Article 40 of the Pharmacovigilance Implementing Measures
Transitional provisions
1. The obligation on the part of marketing authorisation holders, national competent authorities and the Agency to use the terminology provided for in Article 26(2) shall apply from 1 July 2016.