The regulatory system in Slovenia is well-structured and predictable.
Needing to keep pace with rapid change in very many areas – digitalization, artificial intelligence, demographic change, new diseases, for example, the structures and systems associated with local regulatory affairs must develop accordingly. As a result, we can expect to see regulatory change in the country in the coming years. This will be led by the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP). Greater collaboration and dialogue within the healthcare industry in its widest sense will be evident.
As your local regulatory partner Grove has access to the key institutions regulating the market, notably, JAZMP and the Ministry of Health.
Grove provides regulatory consulting services in Slovenia in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY CONSULTING IN SLOVENIA – PRE-SUBMISSION AND SUBMISSION ACTIVITIES
With their comprehensive understanding of local regulatory requirements, 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 SLOVENIA – 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 SLOVENIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs consulting team in the country 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
