The Finnish Medicines Act is proposed to be amended by Government bill (HE 200/2012 vp). The amendments shall implement such safety of medicines regulations that are made to the EU’s Pharmaceutical Directive (Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012). Pharmaceutical Directive was amended by regulating a new chapter that includes pharmacovigilance in detail. Furthermore, provisions on the marketing authorizations of the Pharmaceutical Directive were clarified due to the pharmacovigilance reform. Amendments to the Finnish Medicines Act and the new chapter 4a to the Act would implement the changes to the Pharmaceutical Directive.
The reform concern holders of the marketing authorization and registration, who are required to maintain a system of pharmacovigilance, to monitor safety of marketing authorized and registered products and to observe the balance of risks and benefits. Once pharmaceutical product is placed on the market it is continued to be monitored to assure that any aspect, which could impact the safety profile of a medicine is detected and assessed for the purposes of necessary measures. This monitoring is called pharmacovigilance. The purpose is to ensure the safety of post-marketing inspections. The pharmacovigilance system comprises also provisions on standardization of an adverse reaction reporting within the European Union and thus relevant provisions on the same shall be included in the chapter 4a of the Medicines Act as well.
Amendments are also proposed to the regulation on marketing authorization for medicines that are in the chapter 4 of the Medicines Act. Those amendments are based on revised provisions on pharmacovigilance in order to take them into account while granting marketing authorizations. However, such provisions of reforming the current pharmacovigilance activities in its main features shall be maintained. Another relevant change to remark is a provision on the application for renewal of marketing authorization or registration, which must be made to the Medicines Agency and Development Centre in writing at least nine months before the registration expires.
The main reforms contain a responsibility for the holder of marketing authorization and registration to continue to establish the pharmacovigilance system for one or more of authorized medicinal products or for monitoring registered products. Related information shall be stored in the master file of the pharmacovigilance system, which has to be available for inspection by authorities continuously. Furthermore, it shall be ensured that the key measures of risk management system are included in the conditions of the marketing authorization and registration. The Medicines Agency and Development Center is proposed to have a power to require the marketing authorization holder to make post-marketing safety and effectiveness studies.
As well the reporting of suspected adverse reactions will be harmonized in the EU and thus both, the marketing authorization holders and authorities, will report those reactions only to the EUs pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (the “Eudravigilance database”). EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorization of medicinal products in the Europe. The Eudravigilance database shall be equipped with function to immediately forward such reports on suspected adverse reactions received from marketing authorization holders to the relevant member states of the EU on whose territory the reaction occurred.
The reporting obligation of the holder of the marketing authorization and the registration will be extended in such a way that any serious adverse effects must be reported within 15 days in the European Economic Area and beyond. Other side effects as serious adverse events must be reported within 90 days. The reports of suspected or proven harmful effects can be reported to the member states authorities by their own health care professionals and as a new group by consumers. National authorities shall report of the information received from these serious adverse events within 15 days, and for other side effects, within 90 days to the EudraVigilance database. Marketing authorization holders are ordered to have access on those reports in the EudraVigilance database. Direct reporting to EudraVigilance database shall begin within six months from the date when the database is running and the European Medicines Agency has informed about it.
The said amendments to the Finnish Medicines Act are proposed to come effective during the spring 2013.