Last month July 2014 Next month
S M T W T F S
week 27 1 2 3 4 5
week 28 6 7 8 9 10 11 12
week 29 13 14 15 16 17 18 19
week 30 20 21 22 23 24 25 26
week 31 27 28 29 30 31
No events
Registration/Assessment Guidelines, Forms & Lists PDF Print E-mail
Written by Administrator   
Friday, 15 January 2010 15:38
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.

For more information on the registration process CLICK HERE

 

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.

 

DOWNLOAD HERE:

icon Requirements for registration of a New Drug (128.72 kB 2010-01-15 16:34:55)

icon Requirements for registration of Herbal Products (110.84 kB 2010-01-15 16:36:16)

icon Requirements for assessment of items considered as food and drink (137.27 kB 2010-01-15 16:33:15)

icon List of Requirements for Medical Device (119.22 kB 2010-03-08 15:05:00)

icon Requirements for assessment of Home In-Vitro Devices (18.97 kB 2010-01-15 16:30:41)

icon Guidelines for the sale of energy drinks in Jamaica (113.2 kB 2010-01-15 16:24:16)

 

 

Lists

PDF - List of items now requiring a permit

PDF - List of drugs registered for 2009

PDF - List of drugs registered for January 2010

 

Last Updated on Monday, 08 March 2010 15:14