For those involved in medicines/medicinal products and medical devices in the Polish market developing and maintaining an approved approach to pharmacovigilance and medical device vigilance is vital. The area continues to evolve in terms of the complexity of response required from the marketing authorization holder (MAH).
Legislation introduced in 2013 which improved pharmacovigilance information collection processes and a widening of the definition of an adverse event to include ‘harmful and unintended effects arising from the unauthorized use of pharmaceuticals, such as overdosing, medical errors and off-label use’, introduced a level of data collection/management depth and complexity not previously required.
In Poland, patients are able to report adverse events either directly to marketing authorization holders or to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The pharmacovigilance reporting obligations for healthcare professionals continues to develop alongside this.
Any marketing authorization holder (MAH) is expected to appoint a local qualified person responsible for pharmacovigilance (QPPV) in the country. The MAH must implement and regularly audit a pharmacovigilance system.
The QPPV must speak Polish and must live or have an office in Poland. The MAH needs to be able to meet specific pharmacovigilance data-related requests within explicit timescales. The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products must be advised on a range of specified pharmacovigilance-related issues either as standard or on specific request.
With a complete understanding of local pharmacovigilance procedures and local pharmacovigilance contacts Grove provides a range of pharmacovigilance activities in Poland within a fully comprehensive outsourced pharmacovigilance services solution.
For those involved in pharmaceuticals/medicines/drugs/medicinal products and medical devices, the pharmacovigilance service package comprises: