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    Pharmacovigilance Regulation

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    jaggwe rogers
    This document outlines new regulations for pharmacovigilance in Uganda, including requirements for monitoring drug safety, reporting adverse drug reactions, investigating counterfeit drugs, and related offenses. Key aspects of the regulations include: - Requiring licensed manufacturers and importers to have systems to monitor drug safety and submit periodic safety reports to the National Drug Authority. - Specifying that healthcare professionals must report any serious adverse drug reactions. - Detailing processes for investigating adverse reactions, suspected counterfeit drugs, or other drug safety issues at the Authority's discretion. - Making it an offense to withhold safety information or obstruct the Authority's efforts to obtain information.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Pharmacovigilance Regulation

    Uploaded by

    jaggwe rogers
    48 views10 pages
    This document outlines new regulations for pharmacovigilance in Uganda, including requirements for monitoring drug safety, reporting adverse drug reactions, investigating counterfeit drugs, and related offenses. Key aspects of the regulations include: - Requiring licensed manufacturers and importers to have systems to monitor drug safety and submit periodic safety reports to the National Drug Authority. - Specifying that healthcare professionals must report any serious adverse drug reactions. - Detailing processes for investigating adverse reactions, suspected counterfeit drugs, or other drug safety issues at the Authority's discretion. - Making it an offense to withhold safety information or obstruct the Authority's efforts to obtain information.

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    nda pharmacovigilance

    Original Title

    Pharmacovigilance-Regulation

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    This document outlines new regulations for pharmacovigilance in Uganda, including requirements for monitoring drug safety, reporting adverse drug reactions, investigating counterfeit drugs, and related offenses. Key aspects of the regulations include: - Requiring licensed manufacturers and importers to have systems to monitor drug safety and submit periodic safety reports to the National Drug Authority. - Specifying that healthcare professionals must report any serious adverse drug reactions. - Detailing processes for investigating adverse reactions, suspected counterfeit drugs, or other drug safety issues at the Authority's discretion. - Making it an offense to withhold safety information or obstruct the Authority's efforts to obtain information.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    48 views10 pages

    Pharmacovigilance Regulation

    Uploaded by

    jaggwe rogers
    This document outlines new regulations for pharmacovigilance in Uganda, including requirements for monitoring drug safety, reporting adverse drug reactions, investigating counterfeit drugs, and related offenses. Key aspects of the regulations include: - Requiring licensed manufacturers and importers to have systems to monitor drug safety and submit periodic safety reports to the National Drug Authority. - Specifying that healthcare professionals must report any serious adverse drug reactions. - Detailing processes for investigating adverse reactions, suspected counterfeit drugs, or other drug safety issues at the Authority's discretion. - Making it an offense to withhold safety information or obstruct the Authority's efforts to obtain information.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 10

    STATUTORY INSTRUMENTS

    SUPPLEMENT No. 8 28th March, 2014


    STATUTORY INSTRUMENTS SUPPLEMENT
    to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014
    Printed by UPPC, Entebbe, by Order of the Government.

    S T A T U T O R Y I N S T R U M E N T S

    2014 No. 37.

    THE NATIONAL DRUG POLICY AND AUTHORITY


    (PHARMACOVIGILANCE) REGULATIONS, 2014

    ARRANGEMENT OF REGULATIONS

    Regulation.

    1. Title.
    2. Interpretation.
    3. Requirement for a pharmacovigilance system.
    4. Periodic safety update reports.
    5. Investigations for adverse drug event.
    6. Requirement for health care professional to report.
    7. Reporting of counterfeit drugs.
    8. Investigations into a suspected counterfeit drug.
    9. Offences.

    SCHEDULE

    1263
    S T A T U T O R Y I N S T R U M E N T S
    2014 No. 37.

    The National Drug Policy and Authority (Pharmacovigilance)


    Regulations, 2014.
    (Made under Section 64 of the National Drug Policy and Authority Act,
    Cap. 206)

    IN EXERCISE of the powers conferred upon the Minister responsible for


    health by section 64 of the National Drug Policy and Authority Act and
    on the advice of the National Drug Authority, these Regulations are
    made this 24th day of March, 2014.

    1. Title.
    These Regulations may be cited as the National Drug Policy and
    Authority (Pharmacovigilance) Regulations, 2014.

    2. Interpretation.
    In these regulation unless the context otherwise requires—
    “adverse drug event” means any unwanted medical occurrence in a
    subject to whom a drug is administered and includes an
    occurrence which is not caused by or related to the drug;
    “adverse drug reaction” means a response to a drug which is
    noxious and unintended, and which occurs at doses normally
    used in man for the prophylaxis, diagnosis or therapy of
    disease or for the modification of physiological function;
    “counterfeit drug” means a drug which is deliberately or
    fraudulently mislabeled with respect to its identity, content or
    source;
    “licensed person” means a person licensed under section 14 of the
    Act;
    “periodic safety update report” means a report on the safety
    experience of a drug at defined times, after the drug is
    registered;
    1264
    “pharmacovilance” means the science and activities relating to the
    detection, assessment, understanding and prevention of
    adverse effects or any other possible drug related problem.

    3. Requirement for a pharmacovigilance system.


    (1) A licensed person shall have an appropriate system for
    pharmacovigilance, to manage the safety of the data for the drugs for
    which the licensed person is responsible.
    (2) The following shall have appropriate mechanism of monitoring
    the safety of the drugs that are handled in their day to day activities—
    (a) a manufacturer or importer of drugs who is licensed to do so
    under the Act and regulations made under the Act;
    (b) a licensed person, doctor or health professional who is
    involved in handling drugs intended for human use, in public
    health programs and programs organised and sponsored by
    nongovernmental organisations; and
    (c) any other person as may be determined by the Authority.

    (3) Where the Authority determines that a drug may not be safe to
    use, the Authority shall request a licensed person to submit to the
    Authority—
    (a) a periodic safety update report; and
    (b) any other reports that may be relevant to determine the safety,
    efficacy and quality of the drug, as the Authority may
    determine.

    (4) A report required in subregulation (3) (a) shall be submitted


    using the format in the Schedule to these Regulations, for human drugs
    or veterinary drugs, respectively.

    4. Periodic safety update reports.


    (1) A licensed person shall, for the drugs handled by the licensed
    person, submit to the Authority—
    1265
    (a) on an annual basis, a periodic safety update report of a drug
    that has been manufactured, sold or supplied in Uganda, as the
    case may be, for less than ten years;
    (b) once every three years, a periodic safety update report and the
    efficacy profile of a drug that has been manufactured, sold or
    supplied in Uganda, as the case may be, for more than ten
    years; and
    (c) any other report as the Authority may determine.

    (2) Notwithstanding subregulation (1), the Authority may, where it


    deems necessary, at any time request a licensed person to submit a
    periodic safety update report or any other report as the Authority may
    determine.
    (3) The Authority may, request a licensed person to conduct a
    concise critical analysis of the safety, resistance and efficacy profile of a
    drug and to submit the results of the analysis to the Authority, within the
    time specified.

    5. Investigations for adverse drug event.


    The Authority may conduct an investigation, with regard to a drug
    where—

    (a) an adverse reaction is reported;

    (b) it is suspected or found that a drug of the licensed person does


    not comply with the requirement of the Act;

    (c) there is an international alert with regard to such a drug;

    (d) the drug is recalled in Uganda or in any other country;

    (e) there is need for additional investigations into the drug;

    (f) there is need for educational initiatives to improve the safe use
    of the drugs;
    1266
    (g) there is a change in the scheduling or manufacture of the drug
    to make it safer;
    (h) for regulatory and health promotion interventions, as the
    situation may warrant, including change in supply status or
    withdrawal; or
    (i) where the Authority for any other reason deems it fit to
    conduct an investigation on the drug.

    6. Requirement for health care professional to report.


    A health care professional shall report any serious adverse drug event
    that arises during the process of providing health care.

    7. Reporting of counterfeit drugs.


    (1) Where a drug is suspected to be a counterfeit drug, the licensed
    person, healthcare professional or any other person who suspects that a
    drug is a counterfeit drug shall report to the Authority.

    (2) A person shall not deal in any drug that is confirmed to be a


    counterfeit drug.

    (3) Where the Authority confirms that a drug is a counterfeit drug,


    the Authority shall confiscate the counterfeit drug.

    (4) “Any other person” in sub regulation (1) includes a licensed


    person and a healthcare professional who is employed to handle drugs
    for a public health program or for a nongovernmental organization.

    (5) Where the Authority determines that a drug suspected to be a


    counterfeit needs extra monitoring, the licensed person shall be required
    to submit to the Authority—
    (a) reports of the drug, where the drug has obvious or perceived
    quality defects; and
    (b) any other report which is relevant to the safety, efficacy and
    quality of the drug as the Authority may determine.
    1267
    (6) A report submitted under this regulation shall be in a format
    approved by the Authority or in any other manner as may be prescribed
    by the Authority.

    8. Investigations into a suspected counterfeit drug.


    The Authority may conduct an investigation, with regard to a drug
    where—

    (a) a report of a suspected counterfeit drug is made;

    (b) there is a regional or international alert with regard to a


    counterfeit drug; or

    (c) the Authority deems it fit to conduct an investigation on a


    drug.

    9. Offences
    Any person, who withholds safety information or tries to obstruct the
    Authority from getting information, commits an offence under the Act.

    1268
    SCHEDULE

    FORMATS.
    Regulation 3(4)

    Format of Report on Suspected Adverse Drug Reactions for Human


    Drugs

    Please note that identities of the patient, reporting doctor, pharmacist, nurse
    and health facility are to be kept strictly confidential.

    1. Details of patient

    Surname:
    Other names:
    Age:
    Sex:
    Weight:
    Date of LMP:
    OPD No.:
    Name of health facility:
    District:

    2. Details of the drug


    State the brand and generic names of the suspected drug, indicate why the drug
    was prescribed or taken, state the dates of manufacture and expiry of the drug,
    indicate the route, state the dates when the patient started and stopped using the
    drug, the daily dose, diluents details, lot/batch no. and state whether the drug
    was prescribed or not.

    3. Reaction details
    Please specify and describe the details of the suspected reactions, the date the
    reaction started, the date of notification of the reaction and the date when the
    reaction stopped.

    Mention any treatment that was given to the patient for the reaction. If the
    patient was admitted, record the duration of admission in days, the outcome of
    the treatment (whether the treatment is ongoing, or whether the patient
    recovered or died and if the patient died, indicate the date of death).
    1269
    4. Other drugs used (including self medication, vaccines, herbal
    preparations).
    Record the name of the drug, the indication, daily dose and the dates the patient
    started and stopped using the drug.

    5. Comments.
    Record any other information for example the relevant history, allergies, failure
    of efficacy, counterfeit, test result, follow up data of the drug or patient as the
    case may be.

    6. Details of licensed person who submits report.


    Name:
    Postal address:
    Designation:
    Telephone:
    Telephone/fax number:
    Signature:
    Date:

    1270
    Regulation 3 (4)

    Format of Report on Suspected Adverse Drug Reactions for Veterinary


    Drugs

    Please note that identities of the owner of the animal, veterinary surgeon or
    Para-veterinarian who makes the report and the animal clinic are to be kept
    strictly confidential

    1. Details of owner of animal


    Name:
    Address:
    Telephone number:
    Email address:
    Village:
    Sub-county:
    District:

    2. Details of animal
    Breed:
    Sex:
    Age:
    Weight:
    Productive status:
    Reproductive status:
    Name and identification number of animal:
    Species:

    3. Details of suspected drug


    Record both the brand and generic names of the suspected drug, the condition
    treated, the dates of manufacture and expiry of the drug, the route, the dates
    when the animal started and stopped taking the drug, the dosage and batch
    number.

    4. Drug administered by (if owner is a vet professional, tick both title and
    owner boxes)
    Veterinary doctor
    Owner
    Para-veterinarian
    Others (specify)
    1271
    5. Reaction Details
    Please specify the details of the suspected reactions and indicate whether the
    reaction was immediate or delayed.

    6. Other drugs used within seven days (including drugs administered by


    animal owner, vaccines, herbal preparations)
    Record the name of the drug, the indication, the daily dose and the date the
    animal started stopped taking the drug.

    7. Comments
    Record any other information for example the relevant history, allergies, failure
    of efficacy, counterfeit, test result and follow up data.

    8. Details of the licensed person who submits report


    Name:
    Postal address:
    Designation:
    Telephone and fax numbers:
    Signature:
    Date:

    RUHAKANA RUGUNDA (DR.),


    Minister of Health.

    1272

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