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
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
Grove’s in-country regulatory affairs team provide a full support service
post-submission, and work with clients in the following areas:
Marketing authorization transfer services
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
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 in bulgaria given
any change in national legislation, regulations and policies
Provide relevant safety updates
Key product areas covered:
Food and dietary supplements