Reforms within the Polish healthcare sector since 2000 have led to an increasingly stable and transparent regulatory affairs environment.
The manufacture/import and marketing of medicinal products and medical devices is heavily regulated in Poland, with a number of different entities involved in the regulatory procedures. Further regulatory change is inevitable. Navigating the system is not without its pitfalls and understanding the key regulatory players, structures and systems in what continues to be an evolving regulatory situation is vital to building a sustainable business in the country.
As your local regulatory affairs specialist Grove has access to the key institutions regulating the market, notably, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Ministry of Health.
Grove provides regulatory consulting services in Poland in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY CONSULTING IN POLAND – PRE-SUBMISSION AND SUBMISSION ACTIVITIES
With their comprehensive understanding of regulatory requirements in Poland, 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 specific to the Polish market
- 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 POLAND – 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
- Support for the management of national Agency databases
- Submission of annual specific national declarations
- Packaging/labelling compliance
GROVE REGULATORY AFFAIRS CONSULTING IN POLAND – MONITORING OF REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs consulting team in Poland provide, Grove will:
- Monitor local regulatory change and provide appropriate updates
- Assess national regulatory documentation and provide appropriate updates
- Ensure compliance with the Polish 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
- Food and dietary supplements