Alongside the Bulgarian Ministry of Health, BDA (the Bulgarian Drug Agency) are the two key regulatory affairs players within the Bulgarian healthcare sector. The BDA recognizes that the industry requires predictability and stability and has worked hard to try to keep pace with EU-legislative/regulatory demands within the context of a healthcare system and economy that still need to catch up with the rest of the EU.
Although there are some gaps, industry observers note that the regulatory environment is now more or less in harmony with the EU framework. As such, the pharma and medical device regulations in Bulgaria do afford manufacturers a level of predictability and ease of access.
That said, the manufacture/import and marketing of medicines and medical devices is heavily regulated in Bulgaria. Navigating the system is fraught with pitfalls and understanding the key regulatory players, structures and systems in what will continue to be an evolving regulatory situation is vital to building a sustainable business in Bulgaria.
As your local regulatory affairs specialist in Bulgaria Grove has access to the key institutions regulating the market, notably, BDA (the Bulgarian Drug Agency) and the Ministry of Health.
Grove provides regulatory services in Bulgaria in any one of a number of areas and can, if necessary, act as a full-service regulatory.
GROVE REGULATORY CONSULTING IN BULGARIA – PRESUBMISSION AND SUBMISSION ACTIVITIES
With their comprehensive understanding of local regulatory requirements, Grove’s regulatory affairs consultants in Bulgaria work closely with their clients through the necessary pre-submission and submission activities required. Key within this is:
- Regulatory consulting in Bulgaria – regulatory submissions and registration related services specific to Bulgaria
- Preparation and submission of relevant documentation for medicines to BDA to obtain marketing authorization in Bulgaria
- Medical device registration in Bulgaria
- 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
GROVE REGULATORY SERVICES IN BULGARIA – 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
GROVE REGULATORY AFFAIRS CONSULTING IN BULGARIA – MONITORING OF REGULATORY
REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs specialists in Bulgaria 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
