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 instances where products are deemed safe enough to be placed on the market without formal registration, the Ministry of Health grants a written approval. Once registered or approved, products are allowed importation by way of permits granted by the department on the Ministry’s behalf.
Registration Forms and Requirements
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. These application forms must be supported by the relevant information necessary for the approval process. For application forms and the necessary supporting documentation needed please see relevant forms listed below.