Regulatory services
in Slovakia

Within the context of a population known to be creative, innovative and adaptive, there continues to be a push within the Slovakian healthcare industry for still greater innovation, transparency and patient centricity. Although strict requirements for cost effectiveness continue to challenge manufacturers, the Slovakian regulatory environment is characterized by an openness, predictability and transparency not seen in other Central and Eastern European countries with the exception of the Czech Republic. Attracted by such favourable conditions, new entrants continue to meet with success in the market.

The manufacture/import and marketing of medicinal products, medical devices is heavily regulated (and as a result, predictable), with the State Institute for Drug Control (SUKL) the key institution driving regulatory requirements. Manufacturers are pushing for further regulatory change with some success. Transparency, standardization and predictability have developed as a result of the multi-level dialogues taking place.

Within what is a dynamic, albeit positive, regulatory framework, gaining an understanding of the key regulatory players, structures and systems is vital to building a sustainable business in the country.

As your local regulatory affairs specialist Grove has access to the key institution regulating the market, notably, the State Institute for Drug Control (SUKL). With locally based consultants, Grove knows better than most, how to work through the complexities of the local regulatory submissions.

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

REGULATORY CONSULTING IN SLOVAKIA – PRE-SUBMISSION AND SUBMISSION ACTIVITIES

With their comprehensive understanding of regulatory requirements in Slovakia, 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
  • 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
  • Medical device registration

PHARMA REGULATORY SERVICES IN SLOVAKIA – MAINTENANCE OF REGULATORY APPROVAL/MA

Grove’s in-country regulatory affairs team provides 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

REGULATORY AFFAIRS CONSULTING SERVICES IN SLOVAKIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS

Completing the full-service regulatory package that Grove’s regulatory affairs specialists in Slovakia 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