Empowering your achievement in Eastern European pharma markets

EU pharmacovigilance regulations require each marketing authorisation holder, national competent authorityand EMA to operate a pharmacovigilancesystem. Grove provides a network of local QPPV (Qualified Person for Pharmacovigilance) experts in Poland, Hungary, Czech Republic, Slovakia, Romania, Bulgaria, Slovenia, Croatia, Latvia, Estonia and Lithuaniaas a solution for pharmacovigilance issues at a national level. These highly skilled and continuously trained professionalsprovide a full range of pharmacovigilance and medical device vigilance services to enable Grove clients to maintain compliance with EU drug safety and pharmacovigilance requirements.

Our local pharmacovigilance resources are available on a 24-hour/7 day per week basis to receive notices for any safety information, safety issue or signal for your products. The local contact person reports to the client’s European qualified person responsible for pharmacovigilance activities,in accordance with the laws and regulations applicable in a country.

Grove’s local QPPV personnel takethe responsibility for the collection and accurate documentation of all safety information received on national level and assists with follow-up. Safety information is forwarded to the client within the timeframes and format specified in individual Safety and Medical Information Agreements. Furthermore, we undertake regular monitoring of local publications and medical scientific literature and notify clients of published safety information regarding the products.

Moreover, our pharmacovigilance activities at a national level cover the following areas:
  • Assistance for interaction with Competent Authorities in the country
  • Assistance for interaction with Ethical Committees in the country
  • Continuous update on the national pharmacovigilance and regulatory requirements
  • English translations of local regulations and/or Competent Authorities communication in the country (letters, emails, fax), when available only in local languages.

Most importantly, pharmacovigilance services at a national level ensure patient safety, fulfilment of all local and national regulatory requirements and general compliance with current international guidelines for Good Pharmacovigilance Practices.