With EU membership and a pragmatic approach to encouraging investment in the Latvian market there has been a degree of positive movement in terms of regulatory affairs for new entrants to the healthcare market. Further reforms are needed.
The manufacture/import and marketing of medicinal products and medical devices is heavily regulated in this market. With government activity driving to attract investment in the healthcare sector, further regulatory change is inevitable. Adding another dimension to this there is increasing collaboration between the regulatory authorities in the Baltic states with regards to regulatory matters. Beyond this, there is a pressing need for radical reform within the Latvian healthcare system itself. Navigating the system therefore, is fraught with complexity. Despite its small size, 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 this country.
As your local regulatory affairs partner Grove has access to the key institution regulating the market, notably, the Latvian State Agency of Medicines (SAM).
Grove provides regulatory affairs consulting services in Latvia in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY CONSULTING IN LATVIA – 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 LATVIA – 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
REGULATORY AFFAIRS CONSULTING IN LATVIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs consulting team in provide, Grove will:
- Monitor local regulatory change and provide appropriate updates
- Assess national regulatory documentation and provide appropriate updates
- Ensure compliance with Latvian 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