How to apply for Pharmaceutical License
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Pharmaceutical Licence
Secure a License in order to produce new pharmaceutical drugs.
Common Button banner For Pharmaceutical License
How to apply for Pharmaceutical License
Pharmaceutical Licence
Process Overview
Pharmaceutical Drug Category
What Type of Pharmaceutical Products are you applying for?
One of the below
One of the below
Required Documentation
In order to ensure your application is processed expeditiously please verify that all the information is completed accurately, and the supporting documents/information are submitted along with your request.
Application Form
List of Requirements for Medical Device- FRM-SRD-PR-006-R0
Supporting Documents
to be prepared and submitted.
All copied documents submitted must be certified by a Justice of the Peace.
List of Supporting Documents- see further details on the application form)
Three copies of a summarized statement
Details of the tests conducted
Summary of Effectiveness and Safety
A Certificate of Analysis
Three (3) copies of a draft of every label
Three (3) samples of the device in the finished form
Manufacturing processes and the quality assurance programme designed
The Premarket Approval
Package insert for physicians
Information brochure for patients which include short-term as well as long-term risks.
A statement showing the countries in which the product has been approved and or refused
Any other relevant supporting documents can be uploaded using the Generic Upload tool below
Application Form
List of requirements for Registration of New Drugs (Draft)- FRM-SRD-PR-008-R0
Supporting Documents
to be prepared and submitted.
All copied documents submitted must be certified by a Justice of the Peace.
List of Supporting Documents- see further details on the application form)
Two (2) copies of a summarized Product Characteristics (SmPC)
Details of the tests conducted
Control of active ingredient(s) and final product
Description of the Manufacturing Process of Final Product
Stability study protocol and results for ICH Stability Zone IV
Summary of Clinical/Non- Clinical Studies
Certificate of Analysis
Finished product specification and method of analysis (2 copies)
Three (3) copies of a draft of every label
A “Certificate of a Pharmaceutical Product”
Good Manufacturing Practices Certificate
Copy of License to Manufacture
Copy of Product License issued by the drug regulatory authority
Company profile document for new manufacturers
Copies of agreements/ contracts between parties involved in the manufacturing and marketing of a product.
Representative’s Authorization: Document granted by the drug holder.
A statement showing the countries in which the product has been approved and or refused
Any other relevant supporting documents can be uploaded using the Generic Upload tool below
Determine your eligibility
The main function of Standards Research and Development is to develop new and update existing standards and guidelines relevant to the operation of health care facilities in both the public and private sectors. Quality assurance also resides in this Branch where audit tools are developed and used to assess compliance with standards established for health care facilities in the public and private health sectors.
Most products require registration with the Ministry of Health prior to importation, distribution and sale in Jamaica as outlined in the Food and Drugs Act, 1964. These include pharmaceuticals (prescription and over the counter drugs), herbal preparations, natural health products, products containing vitamins and minerals. The following categories of products are assessed:
- New Drug Moieties
- Generic Drugs, Drug Line Extensions, Herbal products, Vitamins and Minerals
- Drugs for treatment of life threatening illnesses e.g. Cancer, HIV
Fees Payment
Pay the relevant Processing Fees…
The registration fee for each presentation is five thousand dollars (J$5,000.00). Cheques must be made payable to the Permanent Secretary, Ministry of Health.
Processing Time:
Status Approval - Maximum of twenty (20) working days.
Submit your Application
You can choose you preferred submission method, either through the online portal or by presenting your filled form in one of MOHW’s offices.
Once your form and all supporting information/documents have been completed, signed, stamped and certified where required, you may visit and submit your request through the appropriate MOHW Office. All requests should be addressed to the Permanent Secretary of the Ministry.
Online submission
You will be able to submit your application entirely online by using the new JBG portal.
Easy
You will be guided through the process
Reliable
Get updates on your progress in real-time
Quick
Simplifies the collaboration with the MOHW
The address and contact information for the Ministry is indicated below:
Pharmaceutical and Regulatory Affairs
10-16 Grenada Way
Kingston 5
Additional steps required for approval...
Once your request has been submitted, there are a few additional steps that the regulating Ministry must perform. This includes the following:
Desk Verification
Scientific Evaluation/Due Diligence
Committee Decision
Licence Issuance/Refusal
- Process Overview
- Pharmaceutical Drug Category
- Required Documentation
- Determine your Elegibility
- Fee Payment
- Submission
- Additional Steps