Registration/Assessment Guidelines, Forms & Lists

Registration of Drugs and other Items

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.

 

Guidelines

Guidelines for Community and Private Health Facilities

Guidelines for the Conduct of Research

 

Lists

List of Precursor Chemicals

List of Registered Drugs for January – December 2013

List of Registered Drugs for January – July 2014

List of Registered Drugs for January – December 2014

Facilities Registered Under Nursing Homes Registration Act

 

Application Forms

Application For Registration in Respect of a Nursing Home

List of Requirements for Assessment of Ingredients Classified as Food or Drink by the MOH

List of Requirements for Energy Drinks September 2011

List of Requirements for Home Use In-Vitro Devices Assessment Form

List of Requirements for Medical Device

List of Requirements for Registration of a New Drug (Revised)

List of Requirements for the Assessment of Cosmetic

List of Requirements for the Assessment of Cosmetics (Definition of Terms)

List of Requirements for the Importation of Radioactive Substances