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Jamaica Drug Product Registration

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Jamaica Drug Product Registration

Ministry of Health and Wellness Jamaica Drug and Product Registration

Regulatory Authority

Standards and Regulation Division, Ministry of Health

Link for Regulatory Authority

https://www.moh.gov.jm/standards-and-regulation-division/

Local Authorised

Yes

Registration Fee

  • Application fee JMD 26,000
  • Registration fee up to JMD 300,000

License Validity

5 years.

Pharmaceutical and Regulatory Affairs

Pharmaceutical and Regulatory Affairs focuses on the following three (3) areas:

  • Product Registration
  • Import Permit Processing

Registration and Monitoring of Institutions and Facilities

Jamaica Drug Product Registration

The Drugs and Other Items Act 1940

Among the key regulatory functions that are done through Pharmaceutical & Regulatory Affairs Department include registration of drugs and other products/items. It includes scientific evaluation of the technical documents provided during the registration that leads to license of a drug or another related product. 

It is regarded as one of the principal tools for ensuring compliance with the quality, safety, and efficacy of drugs as well as of other products covered by the Food and Drugs Act and Regulations.

The term ‘drug’ refers to any material that meets the definition specified in the Act. These include substances that must be registered such as drugs, medicinal plants and some vitamins and supplements. There may also be a registration of these therapeutic claims that may be made by cosmetic, food or device.

In cases where products, which are secure enough to be put on the market without certification, get a written approval from the Ministry of Health. After registration or approval of products, permissions are given to permit importation through issues made on behalf of the Ministry by the department.

Registration Forms and Requirements

Before an item is registered or assessed, a form is first completed and submitted to the Ministry of Health, Standards and Regulations Division. These application forms must be accompanied by the required information for the process of approval. Relevant forms are listed below for application forms and the relevant supporting documentation needed.

Registration/Application Form

  • The first step involves completing the official registration/application form provided by the Ministry of Health. This form is typically specific to the type of product or item being registered.

Supporting Documentation

The application form must be accompanied by comprehensive supporting documentation. The exact requirements may vary depending on the nature of the item, but commonly required information includes:

  • Product Information: Detailed description of the item, including its name, composition, and intended use.
  • Manufacturing Details: Information about the manufacturing process, location, and facilities. This may include Good Manufacturing Practice (GMP) compliance details.
  • Quality Control Measures: Documentation outlining quality control procedures to ensure the consistent quality of the product.
  • Safety Data: Scientific data establishing the safety of the product for human use, including any toxicity studies or safety assessments.
  • Efficacy Data: Scientific evidence demonstrating the efficacy of the product, especially in the case of pharmaceuticals.
  • Labelling and Packaging: Samples of labels and packaging materials, ensuring compliance with regulatory standards.
  • Pharmacovigilance Plan: For pharmaceuticals, a plan for monitoring and reporting adverse reactions or side effects.
  • Authorized Representative Details: Information about the entity or individual acting as the authorized representative, if applicable.
  • Fees and Payment Details: Details on the fees associated with the registration process and payment instructions.

Submission Process

  • Clear instructions on how to submit the completed application form and supporting documentation. This may include details on the preferred mode of submission (physical or electronic) and any specific deadlines.

Review and Approval Process

  • Information on the subsequent steps, including the timeline for review, potential inspections, and the criteria used for approval.

Import Permit Processing

Before importation, approval is necessary for goods under the purview of the Food and Drugs Act, 1964 and Precursor Chemicals Act, 2005. The customer should fill in the appropriate application form and pay the application fee prior the importation. Imports of a product are allowed only when the same has been considered, approved, and before the sale or use in Jamaica.

A permit is required for the importation of the following items:

  • Precursor Chemicals, Psychotropic Substances, Narcotic Drugs and other controlled Substances (Yellow Form)
  • Foods and Drugs (Blue Form)
  • Cosmetics, Chemicals and Medical Devices (Pink Form)

Yellow Form (Precursor Chemicals, Psychotropic Substances, Narcotic Drugs, and other controlled Substances)

  • Used for the import of controlled or restricted substances that have potential for abuse or addiction. These include narcotics, psychotropic drugs, and precursor chemicals used in manufacturing narcotics and psychotropics.
  • Requires providing information on the composition, intended use, dosage form, quantity to be imported, etc.
  • Subject to thorough review to verify the legitimacy of the requested substances. Extra scrutiny given to ensure no potential for diversion or abuse.
  • Approval granted only if the need for importation is justified, and measures are in place to prevent misuse or illegal diversion.

Blue Form (Food and Drugs)

  • For pharmaceutical products, natural health products, medical devices, veterinary drugs, foods, food additives, etc.
  • Application must include product composition, claims, directions for use, safety data, manufacturing details, labelling specifics, etc.
  • Rigorous scientific review of quality, safety, efficacy claims, and regulatory compliance.
  • Testing may be required to verify composition, purity, potency, sterility, stability.
  • Approval given only to products meeting high standards of quality, safety and effectiveness.

Pink Form (Cosmetics, Chemicals, Medical Devices)

  • Covers a wide range of consumer products like cosmetics, household chemicals, medical devices, etc.
  • Requires details on product composition, specifications, quality control, safety studies, labelling, etc.
  • Review focuses on safety, quality control, and regulatory compliance.
  • Confirmation needed that ingredients, testing, manufacturing, and labelling meet Jamaican standards.
  • Approval granted only to products not posing undue risk with proper labelling as per regulations. 

Registration and Monitoring of Institutions and Facilities

Nursing Homes Registration Act in Jamaica:

  • Any facility that provides accommodation, nursing care, and treatment to people suffering from illnesses, injuries, or disabilities requires registration with the Ministry of Health.
  • The specific facilities covered include:

Private Hospitals – Privately owned and operated hospitals or clinics providing inpatient nursing care and medical treatment.

Professional Practices – Facilities such as doctors’ offices that provide nursing care and minor medical treatments.

Homes for Senior Citizens – Residential facilities providing nursing care and support services for seniors.

24 Hour Nursing Homes – Facilities dedicated to providing 24-hour nursing care for chronically ill, disabled, or elderly residents who cannot care for themselves.

Infirmaries – Long-term care facilities providing nursing care for the chronically ill or disabled who need constant care and supervision.

Adult Day Centres – Offer supervised care and nursing services during the daytime for disabled/elderly adults who live at home.

Charitable Organization Homes – Residences operated by charities to provide nursing care for the poor, homeless, or those lacking family support.

Convalescent Homes – Short-term skilled nursing care and rehabilitation services for recovering patients.

Ambulatory Services – Facilities providing outpatient nursing care such as wound care, IV therapy, dialysis.

Dialysis Services – Outpatient facilities specifically for dialysis treatment and nursing care.

  • Psychiatric nursing homes have specialized mental health oversight but are also monitored by the Ministry for basic standards.
  • Annual renewal of registration is required for compliance monitoring and quality assurance. Facilities are regularly inspected.
  • The Act aims to ensure appropriate levels of nursing care, services, staffing, safety, and oversight at all facilities caring for Jamaica’s ill and infirm.

Reporting of Suspected Adverse Reactions (Serious and Non-Serious)

Submission of Reports

  1. Suspected adverse reaction (ADR) reports can be submitted to the National Pharmacovigilance Centre (NPvC) by various sources, including healthcare professionals, consumers, marketing authorization holders (MAHs), or other organizations.
  2. Only valid Individual Case Safety Reports (ICSRs) qualify for reporting.

Minimum Requirements for Reporting

  • Patient Information: Information about one single identifiable patient, including initials, patient identification number, date of birth, age, age group, or gender. The information should be as complete as possible.
  • Suspected Adverse Reaction(s): At least one suspected adverse reaction should be reported. An unspecified adverse reaction without further details does not qualify as a valid ICSR.
  • Suspected Substance/Medicinal Product: At least one suspected substance or medicinal product involved in the adverse reaction should be reported.
  • Reporter Information: Information about one or more identifiable reporters (primary sources), including their qualification (e.g., physician, pharmacist, other healthcare professional, consumer, or other non-healthcare professional), name, initials, or address. Contact details for the reporter should be recorded whenever possible to facilitate follow-up activities.

Incomplete Cases and Follow-Up

  1. If any of the above four elements are missing, the case is considered incomplete and does not qualify for reporting.
  2. Follow-up activities are necessary to obtain additional detailed information relevant for the scientific evaluation of the cases.

Reporting Timelines

  • The clock for reporting a valid ICSR starts as soon as the information containing the minimum reporting criteria is brought to the attention of any healthcare provider or personnel of the marketing authorization holder, including medical representatives. This date is considered day zero.
  • Reporting timelines are based on calendar days:
    1. Serious valid ICSRs should be reported within 15 days from the date of receipt of the reports.
    2. Non-serious valid ICSRs should be reported within 90 days from the date of receipt of the reports.

Reporting Channels

  1. MAHs are responsible for reporting any adverse reactions involving their products registered in Jamaica.
  2. MAHs may use the local PharmWatch Drug Monitoring Form or the Council for International Organizations of Medical Sciences (CIOMS) form for reporting ADRs occurring in Jamaica.

Submission of Reports

Reports can be sent via email to PharmWatch@moh.gov.jm or mailed to the following address: PharmWatch Standards and Regulation Division Ministry of Health Masonic Building, 45-47 Barbados Avenue Kingston 5, Jamaica, West Indies

Periodic Benefit-Risk Evaluation Reports (PBRERs) Submission

  1. MAHs are responsible for sharing post-market surveillance data and PBRERs/PSURs with the Standards and Regulation Division (SRD).

PBRERs must be submitted based on specific timelines, as outlined in the provided guidelines, and should adhere to the ICH Guideline E2C (R2) format.

Substandard and Falsified Medical Products

SF medical products threaten public health because they can harm the patients and fail to treat the targeted indications. Products from all classes of therapeutics have been affected as such medicines, vaccines and diagnostic agents. It affects the whole world. Indeed, forged medical supplies are produced all over the world and in all areas of the world. 

Both generic and innovator drugs are involved. Even though antibiotics and anti-malarial are commonly affected, products vary from costly anti-cancer products to affordable pain treatments.

·       Prevention,

·       Detection, and

·       Response

Impact of Substandard and Falsified Medical Products:

Identifying and Reporting a Substandard or Falsified Medical Product

Substandard and falsified medical products present significant challenges in detection due to their deceptive nature. Falsified products are often meticulously designed to resemble genuine ones, making them difficult to distinguish visually. While they may not immediately cause obvious adverse reactions, these products frequently fail to effectively treat the intended disease or condition, leading to serious health consequences, including death.

Identification Methods

  • Packaging Examination
    • Careful examination of the packaging is crucial. Look for any signs of damage, spelling mistakes, or grammatical errors, which may indicate a falsified product.
  • Check Dates and Details
    • Verify the manufacture and expiry dates on the packaging and ensure they match the dates on the inner packaging. Discrepancies may signal a falsified product.
  • Physical Inspection
    • Inspect the medicine itself to ensure it appears correct, without discoloration, degradation, or unusual smells. Any abnormalities may indicate a substandard or falsified product.
  • Pricing Consideration
    • Suspiciously low prices compared to market norms should raise concerns, as this could indicate a substandard or falsified product.
  • Seek Professional Advice
    • If you suspect that a product is not working properly or have experienced an adverse reaction, consult your pharmacist, doctor, or another healthcare professional immediately for guidance.

Reporting Procedure

  • Suspected substandard or falsified medicinal products should be reported to the Standards and Regulation Division using the PharmWatch Drug Monitoring Form, which can be accessed at the following link: PharmWatch Drug Monitoring Form.
  • When reporting, it is crucial to include the batch number and a photograph of the product for accurate identification.

Submission Options

  • Completed forms can be submitted via email to PharmWatch@moh.gov.jm or mailed to the following address:

PharmWatch Standards and Regulation Division Ministry of Health Masonic Building 45-47 Barbados Avenue Kingston 5 Jamaica, West Indies

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