This section explains what is termed as a medicine and their different categories.
Information is also given to provide guidance on the type of applications and how to apply for the approval of medicines that can be made available for use in Sri Lanka.
Definition of a medicine:- Any substance or mixture of substances manufactured, sold, offered for sale or represented for use in -
- The diagnosis, treatment, mitigation or prevention of disease, abnormal physical states or the symptoms thereof in man or animal.
- Restoring, correcting or modifying functions of organs in man or animal
- A medicine or combination of medicine ready for use and placed on the market under a special name or in a characteristic form, both patent and non-proprietary preparations;
- A product made out of medicinal herbal extract;
- Nutraceutical with therapeutic claims; and
- Vaccines and sera,
- but does not include an Ayurvedic medicine or a Homoeopathic medicine;
The NATIONAL MEDICINES REGULATORY AUTHORITY ACT, No. 5 OF 2015 provides the authority to the NMRA to regulate all aspects pertaining to medicines.
National Medicines Regulatory Authority (NMRA) will thereby regulate and control manufacture, importation, storage, distribution, transportation, pricing, wholesale and retail sale, advertising, and disposal of medicines to ensure that medicines made available in the country are of good quality, efficacious, safe, and affordable.
The National Medicines Regulatory Authority Act specifies that no person shall manufacture or import any medicine without registering such medicines with the NMRA.
The Medicines Evaluation Committee (MEC) formed under NMRA Act will use registration and certification procedures to carry out scientific and technical reviews, inspections and surveillance activities of the medicines forwarded for registration to ensure the quality, efficacy, safety, need and cost of such medicines. The MEC consist of experts drawn from various specialties in medical and pharmaceutical fields who meets monthly to decide on applications submitted for marketing authorization of medicines and to make policy decisions relevant to marketing authorization of medicines.