Previous instability within the regulatory affairs framework in Romania, and a relative lack of transparency compared to some other Central and Eastern European markets together with an unpredictability of clawback application left many struggling in recent years. Short-term balance sheet issues and a resultant inability to plan for the future and invest accordingly have not been uncommon.
The last five years have, however, seen significant change within the Romanian healthcare market and the associated procedures for regulatory affairs. Measures have been taken to try to investigate and address corruption issues related to procurement decisions, and greater clarity has been introduced with regards to local pricing and reimbursement policies and procedures.
As your local regulatory partner Grove has access to the key institutions regulating the market, notably, the National Agency for Medicines and Medical Devices (NAMMD), the Ministry of Health, and the National Health Insurance House (NHIH).
- NAMMD’s key areas of responsibility relate to: the issue of marketing authorizations, wholesale distribution authorizations and manufacturing and import licenses; the authorization of clinical trials; supervision of advertising and promotional activities; health technology assessments for medicines; the approval of the donation of any medicines; and, the monitoring of all pharmacovigilance activities.
- In addition to managing the social health insurance system, NHIH has considerable influence with regards to the reimbursement of medicinal products.
- The Romanian Ministry of Health is notable for its role in approving maximum prices for medicinal products, the regulation of medicine reimbursement and its organization of national tenders for the acquisition of, amongst other products, medicines and medical devices.
Grove provides regulatory consulting services in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY CONSULTING IN ROMANIA – 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 affairs consulting – regulatory submissions and registration related services specific to the Romanian 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 SERVICES IN ROMANIA – 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
- Support for the management of national Agency databases
- Submission of annual specific national declarations
- Packaging/labelling compliance
REGULATORY AFFAIRS CONSULTING IN ROMANIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs consulting team in Romania 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
- Food and dietary supplements