Malta will soon have to set up a new website that will give patients more access to information about the type of medicines they are using and allowing them to report any adverse effects.
The new requirement, aimed at strengthening patient safety, will be introduced following the approval of new rules by the European Parliament.
According to the new “pharmacovigilance” directive, the national web portals will have to be linked to a central EU system and will include assessment reports, summaries of product characteristics and patient information leaflets. The portals will also tell patients how to report any suspected adverse reactions.
The system will be accessible to member states, the European Medicines Agency and the European Commission, while access “to an appropriate extent” will be available to industry, doctors and the public.
The new directive also includes elements of additional monitoring of certain new medicines, which will be identified by a black symbol and an explanatory sentence.
Furthermore, the new rules will require the European Commission to report back within two years on how to improve the summary of product characteristics and package leaflets. If appropriate, the Commission may also present proposals to improve the readability, layout and content of these documents.
Welcoming this development, John Dalli, the EU’s Commissioner responsible for Health and Consumer affairs, said the legislation will ensure greater patient safety and improved public health.
“Once implemented, the new legislation will strengthen and modernise the current system for monitoring medicinal products for human use in the EU, making it more robust and transparent”, Commissioner Dalli said.