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Pharmaceutical Licence

Secure a License in order to produce new pharmaceutical drugs.

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How to apply for Pharmaceutical License

Pharmaceutical Drug Category

What Type of Pharmaceutical Products are you applying for?

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.

Medical Device
Choose
Pharmaceutical Drug
Choose

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

Apply now for your Licence

The address and contact information for the Ministry is indicated below:

Pharmaceutical and Regulatory Affairs

10-16 Grenada Way
Kingston 5

Phone 876-633-8172

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