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
EU's 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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.