The smallest of the Balkan countries, there has been a recognition of areas of investment need within regulatory affairs in Montenegro (human resources – scientific and regulatory expertise, trained inspectors, administrative capacity, for example) and the government continues to address these issues and alongside this develop the regulatory system. Regulatory refinement is further driven by the country’s long-term ambition to become a member of the EU and there is some harmonization of the regulatory environment with the EU as a result.
The local regulatory requirements are underpinned by the Law of Medicines. The relevant legislation is comprehensive but still the regulatory submissions remains less than optimal in terms of transparency and predictability.
As your local regulatory partner Grove has access to the key institutions regulating the market, notably, the national Agency for Medicines and Medical Devices (CALIMS) and the Ministry of Health.
Grove provides regulatory consulting services in Montenegro in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY CONSULTING SERVICES – 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 MONTENEGRO – MAINTENANCE OF REGULATORY APPROVAL/MA
Grove’s in-country regulatory affairs team provide 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 local 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 requirements for regulatory affairs 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
