The manufacture/import and marketing of medicinal products and medical devices is heavily regulated in the Serbian market, with a number of different entities involved in the regulatory procedures. High levels of bureaucracy are evident.
Increasingly constructive dialogue between industry and the regulators (driven as a result of industry frustration) however, together with pressure created from the need to prepare for future membership of the EU should mean positive regulatory change. Understanding the key regulatory players, structures and systems within an evolving regulatory situation is vital to building a sustainable business in the country.
As your local regulatory partner Grove has access to the key institution regulating the market, notably, the Medicines and Medical Devices Agency (ALIMS) as well as the Ministry of Health.
Grove provides regulatory consulting services in Serbia in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY AFFAIRS CONSULTING SERVICES IN SERBIA – PRE-SUBMISSION AND SUBMISSION ACTIVITIES
Grove’s in-country regulatory affairs team provides a full support service post-submission, and work with clients in the following areas:
- Regulatory consulting – regulatory submissions and registration related services specific to the Serbian 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 CONSULTING IN SERBIA – 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 SERVICES IN SERBIA – 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 Serbian 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
