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Procedure NamePharmaceutical Product Registration- MOH
Description

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

Fee $ 5,000 JMD

Required Information

No.

Type of information

Note

1

 Application Form, supporting documents 

Process Steps

Step 1

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

Step 2

Applicant prepares the document and pays prescribed fee 

Step 3

The cashier accepts payment and issues the receipt

Step 4

 The receipt is received 

Step 5

Applicant visit MOH and makes the  paper application and submits documentation 
Step 6  Officer reviews submission with client 
Step 7

a) If documentation is deemed incomplete then:

i) The cashier accepts payment and issue required 

b) The payment has been made require

Step 8

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

Step 9

 If the product requires testing then:

i)  Samples are sent to the Government Chemist

ii) Officers receives report from Government Chemist

iii) Clinical Data received

If the product does not require testing then clinical data is received  

Step 10 Officer then presents findings to the Committee
Step 11 The application is reviewed 
Step 12

If additional information is received then:

i) Applicant is requested to provide additional information or correct documentation 

ii) Applicant receives advice about required information and information is provided by the applicant 

iii) Applicants will follow Step 9 after additional information is given by the applicant

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

Step 13

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

 

CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
Registration of New Drugs (Foods and Drugs Act 1964)15-02-201915-02-2019Ministry of Health & WellnessThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
License for the Registration of Pharmaceutical ProductsLicensing RequirementMinistry of Health & WellnessA person shall not sell, manufacture, import or distribute drugs which are not registered with the Ministry of Health and a fee of $25.00 has been paid in respect of such registration.The Minister of Health has the discretion exempt any person from these requirements.The Food and Drugs Act09-09-9999Good