As a historically conservative nation, this trait is evident within regulatory affairs in Lithuania. Conservatism does manifest itself as loyalty when it comes to business relationships, and as a result successful market entry often requires considerable patience. Complexity is added in that competition within the Lithuanian healthcare sector is considerable given the geographic proximity of the country to Poland. Many healthcare companies already operating in Poland are keen to gain a share of the Lithuanian market.
The manufacture/import and marketing of medicinal products and medical devices is heavily regulated, with several different entities involved in the regulatory procedures. Further regulatory change is desperately needed. 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 partner in the Lithuanian market Grove has access to the key institutions regulating the market, notably, the State Medicines Control Agency (SMCA) and the Ministry of Health.
Grove provides regulatory consulting services in Lithuania in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services in the country.
REGULATORY CONSULTING IN LITHUANIA – 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
- 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
REGULATORY AFFAIRS SERVICES IN LITHUANIA – 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 – MONITORING OF LOCAL REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs consulting team 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
