Regulatory affairs, pharmacovigilance and market access services in Hungary

With a team of professional, experienced locally based consultants, Grove is a highly-respected provider of pharmaceutical consulting in Hungary, including regulatory affairs, pharmacovigilance and market access consulting services.

Those involved in the local pharmaceutical industry are broadly positive for the future. This notwithstanding, the regulatory process is comprehensive and necessarily complex, somewhat opaque, and often frustratingly lengthy. Price controls are exceptionally tight. There is no room for error – delays and fines for non-compliance are common but can be avoided with expert local knowledge. Pharmacovigilance requirements are strict but again, with practical local insight, manageable.

The hope is that future legislative changes will simplify the regulatory procedures and introduce greater transparency. Currently however, the system is such that without an in-depth understanding of the Hungarian reimbursement system new market entrants will find it extremely difficult to develop an appropriate approach to pricing and reimbursement submissions. Access to a local regulatory partner and to local QPPV services is an essential pre-requisite to executing successful market entry and development.

As a specialist healthcare consulting firm, Grove’s expertise in Hungary spans four key areas:

  • regulatory affairs consulting (including regulatory intelligence)
  • pharmacovigilance services
  • market access, including pricing and reimbursement applications
  • market assessment including opportunity evaluation, regulatory risk assessment, intelligence on medical device regulations and routes to market


For over twenty years Grove has successfully provided regulatory, PV and market access services to a wide range of clients to help them navigate the specifics of the Hungarian market. With experienced locally based consultants, clients gain access to an unrivalled depth of local knowledge and understanding in all areas associated with entering and operating in the country.

Pharmaceutical consulting, regulatory affairs, pharmacovigilance, market access and market assessment services are all key areas of expertise for Grove.