• The Principal investigator who intends to conduct a clinical trial in Sri Lanka shall make the application to NMRA. However in situations where a sponsor or a person designated by the sponsor (eg: CRO) or any local parties involving the coordination of a clinical trial (eg: Site management organization) such details should be disclosed to the authority.
• Application must be in filled in English language and all other data, particulars supporting documentations, labels and package inserts must also be in English.When supporting documentation is not originally in English, a copy of the document in its original language, accompanied by authenticated translation in English shall be submitted.
• Application should be submitted manually (one hardcopy and soft copy on appropriate data storage device as Portable Document Format (PDF) files) in a hard file cover ( box file)
• The stipulated Application Form should accompanied by a covering letter with essential documents as described in the Clinical Trial Guideline.

(Refer more details GL-019- Guideline for the conduct of Clinical Trials in Sri Lanka)