Category

Licensing Procedure 

Responsible Agency       

Pharmaceutical and Regulatory Affairs

Address: 10-16 Grenada Way

Kingston 5

Phone: 876-633-8172

Email:

Legal base of the Procedure

The Foods and Drugs Act

No.

Type of information

Note

1

Step 1

Applicant visits/ calls MOH for the List of Requirements and information is provided by MOH officer 

Step 2

Step 3

The cashier accepts payment and issues the receipt

Step 4

 The receipt is received 

Step 5

a) If documentation is deemed incomplete

i) The application requested to provide additional or correct documentation 

ii) The applicant pays the prescribed fee 

iii) The cashier accepts payment and issue required 

b) A payment has been made require

a) If payment has not been made then:

i) The applicant pays the prescribed fee

ii) The payment is received and receipt is issued 

b) If payment has been made receipt will be issued and the product requires testing

 If the product requires testing then:

i)  Samples are sent to the Government Chemist

ii) Officer receives report from Government Chemist

iii) Scientific Officer reviews Clinical Data and Studies 

If the product does not require testing then Scientific Officer reviews Clinical Data and Studies 

If the submission is a new moiety then:

i) A scientific officer reviews studies 

ii) Additional information may be required 

If the submission is not a new moiety then:

i) Officer presents findings to Committee 

ii) Committee reviews application 

If additional information is required then:

i) Then applicants are required to flow step 10 (i and ii) 

If no additional information is required then the product will be considered for approval

If the product is not  approved then:

i) then the applicant is notified about rejection in writing 

ii) Importer receives a rejection letter 

The product will be approved 

If the product is a List 4 then:

i) Product Information sent to Pharmacy Council for listing 

ii) Officer receives product listing 

iii) Product Registration is prepared 

iv) Product License is issued to the applicant 

v) Product License is received 

If the product is not under list 4 then:

i) Product Registration is prepared 

ii) Product License is issued to the applicant 

iii) Product License is received