Act of 27 September 2013 Belatedly Implements the EU Pharmacovigilance Directive
On 25 November 2013, the Act of 27 September 2013 on the change of the Act – Pharmaceutical Law and some other acts (Journal of Laws of 2013, item 1245) came into force.
The modified system, which belatedly implements an EU pharmacovigilance directive, is intended to be more effective than the current system and contain stronger links to the EU system.
Key changes include:
- improving information-collecting procedures about suspected adverse reactions to medicinal products
- widening the definition of adverse reaction to allow more comprehensive data to be collected. The new definition will include harmful and unintended effects arising from the unauthorised use of pharmaceuticals, such as overdosing, medical errors, and off-label use
- introducing a clearer division and more detailed specification of the duties of regulatory authorities and marketing authorisation holders to collect and assess information about suspected adverse reactions to pharmaceuticals and to cooperate with the European Medicines Agency
- entitling patients to report adverse reactions directly to marketing authorisation holders, or to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- introducing new obligations, where there are safety concerns about a pharmaceutical product, so that marketing authorisation is only granted subject to the holder conducting post-authorisation safety and efficacy studies, and complying with stricter obligations on the recording or reporting of suspected adverse reactions than those provided by the new law
- Monika Duszynska and Bartosz Michalski, cms-cmck.com