For those involved in medicines/medicinal products and medical devices in Slovakia developing and maintaining an approved approach to pharmacovigilance and medical device vigilance is vital.
As a member of the EU, Slovakia follows EU pharmacovigilance guidelines which state that ‘the marketing authorization holder (MAH) must have an appropriate system of pharmacovigilance and risk management in place to assure responsibility and liability for its products on the market and to ensure that appropriate action can be taken, when necessary’. Mandatory reporting requirements are updated periodically.
As the competent local authority, the State Institute for Drug Control (SUKL) is responsible for detailing the specific requirements that the MAH must meet related to pharmacovigilance in the country. SUKL is further responsible for ensuring that appropriate pharmacovigilance activities are carried out by marketing authorization holders. Within this, SUKL will carry out inspections related to good PV practice. Further to this, key activities are to:
- Collect, monitor and analyze data associated with suspected adverse drug reactions
- Assess the risks associated with the use of medicinal products
- Assess the conditions under which medicinal products may be used
- Communicate the risks of medicines with healthcare providers and consumers
- Produce a non-periodic journal on risks associated with medicinal products
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
Any marketing authorization holder (MAH) is expected to appoint a local pharmacovigilance contact/manager. The QPPV person may be based outside Slovakia, but all pharmacovigilance-related systems established should be applied.
The local pharmacovigilance contact should be able to communicate in either the Czech or Slovak language. The MAH must inform the State Institute for Drug Control of any changes related to the contact details for the local pharmacovigilance contact/manager.
With a complete understanding of local pharmacovigilance processes and local pharmacovigilance contacts Grove provides a range of pharmacovigilance services in the country.
A FULLY COMPREHENSIVE SOLUTION FOR LOCAL PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for pharmacovigilance services in Slovakia for clients unable or unwilling to invest in the development of relevant systems on their own account.
With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.
For those involved in pharmaceuticals/medicines/drugs/medicinal products and medical devices, the pharmacovigilance service package comprises:
- Full-time (24/7) service of a local QPPV (Qualified Person Responsible for Pharmacovigilance)
- 24-hour cover for adverse event reporting
- In-time case reporting
- End-to-end processing of safety information
- Production of PSUR (periodic safety update reports)
- Production of individual case study reports
- Access, as and when appropriate, to local healthcare professionals and authorities
- MLM (Medical Literature Monitoring) services
- Pharmacovigilance training for the client’s local sales force
- System quality control checks to ensure full audit compliance
