Pharmaceutical License
Process Overview
Discover the application process and what steps must be taken in order to secure a Licence to produce pharmaceutical drugs.
Registration of drugs and other products/items are major regulatory functions executed through the Pharmaceutical & Regulatory Affairs Department. It involves in-depth scientific evaluation of the technical documentation submitted in support of registration resulting in licensing of a drug or other related product. It is one of the primary mechanisms through which the quality, safety and efficacy of drugs, and other products mentioned in the Food and Drugs Act and Regulations are ensured.
‘Drug’ refers to any substance that conforms to the definition prescribed by the Act. Such substances generally require registration and include drugs, herbal preparations and some vitamins and supplements. Registration may also be required for any cosmetic, food or device making therapeutic claims.In order for an item to be registered or assessed, a form must first be completed and submitted to the Ministry of Health, Standards and Regulation Division.
The process for Registration of Pharmaceutical Products involves broadly the following steps:
- application and payment
- application pre-screening and document verification
- scientific assessment
- evaluation by the Product Registration Committee (PRC)
- approval/rejection of the application
- if approved – registration of the product(s).