National Medicines Regulatory Authority (NMRA) of Sri Lanka has declared the ‘List of Countries’ to be exempted from the manufacturing site audits. Essentially, this list refers to the respective health authorities in the specified countries, also termed as ‘’Reference Countries.’’ The health authorities included in the list are:
- US FDA
- Health Canada
- MFDS-South Korea
An applicant with approval of their manufacturing site from any of the health authorities will be automatically granted exemption from the time-consuming and cost-intensive site audits by the NMRA, Sri Lanka. This exemption is not applicable for manufacturers of Cosmetics, Food supplements, Class 1 and Class 2a devices.
However, as mandated by the NMRA, all Pharmaceutical manufacturers must register the CP (Company profile or manufacturing site) through a Local agent in Sri Lanka. Without a CP registration certificate, the NMRA does not allow the submission of the sample license application or product registration application to the E-NMRA website. This process is mandatory for manufacturers of Class 2b and Class 3 medical devices.
If the manufacturer is registered with a Health Authority that is not included in the list, they would be subject to a manufacturing site visit at any given time from the NMRA (dependent on CP registration and acceptance or rejection from the NMRA). This opportunity given by the NMRA welcomes manufacturers to register their products and set up business operations in Sri Lanka.
In a nutshell, the applicants must be aware of the end-to-end product registration, Health Authority interactions, local representation, market authorization and Regulatory intelligence. How accurate is your knowledge of the regional Regulatory processes? Evaluate with an expert. Stay informed. Stay compliant.