Regulatory services
in Czech Republic

Underpinned though it is by relatively strict, complex structures, the regulatory affairs environment in the Czech Republic is predictable and transparent and as a result many see this as an attractive market within which to establish a base for their Central and Eastern European operations.

All areas of business within the regulatory framework are tightly controlled by one institution – SUKL, the State Institute for Drug Control.

There is considerable optimism within the local healthcare sector for the future, with dialogue between SUKL and the pharmaceutical industry unguarded and positive. On the back of multi-level industry-wide dialogue, there is evidence of a move towards even greater openness and transparency within the national regulatory system - a system that is already predictable, with all the benefits that brings. Such collaborative efforts will be to the benefit of all stakeholders and there is much to be said for knowing with whom, where and when to engage in discussion. There is much to be learnt from the experience of others in the market today.

As your local regulatory affairs specialist Grove has access to the key institutions regulating the market, notably, the State Institute for Drug Control (SUKL) and the Ministry of Health.

Grove provides regulatory consulting services in the Czech Republic in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.

REGULATORY CONSULTING IN THE CZECH REPUBLIC – PRE-SUBMISSION AND SUBMISSION ACTIVITIES

With their comprehensive understanding of local regulatory requirements in the Czech Republic, Grove’s regulatory affairs consultants work closely with their clients through the necessary pre- submission and submission activities required. Key within this is:
  • Regulatory consulting – regulatory submissions and registration related services
  • Preparation and submission of relevant documentation for drug registration and marketing authorization
  • Medical device registration
  • Liaison with local agencies to monitor progress
  • Assistance with packaging/labelling approval (packaging material submissions, labelling compliance/approval)
  • Readability testing for local language Patient Information Leaflets

REGULATORY SERVICES IN THE CZECH REPUBLIC – MAINTENANCE OF REGULATORY APPROVAL/MA

Grove’s in-country regulatory affairs team provide a full support service post-submission, and work with clients in the following areas:
  • Post-marketing applications
  • Marketing authorization transfer services
  • Variations
  • Renewals
  • Notifications
  • Support for the management of national Agency databases
  • Submission of annual specific national declarations
  • Packaging/labelling compliance

GROVE REGULATORY AFFAIRS CONSULTING IN THE CZECH REPUBLIC – MONITORING OF REGULATORY REQUIREMENTS

Completing the full-service regulatory package that Grove’s regulatory affairs specialists provide, Grove will:
  • Monitor local regulatory change and provide appropriate updates
  • Assess national regulatory documentation and provide appropriate updates
  • Ensure compliance with local regulatory requirements given any change in national legislation, regulations and policies
  • Provide relevant safety updates
Key product areas covered:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements