PHARMACY AND MEDICINES REGULATORY AUTHORITY

CHAPTER 35:01
PHARMACY AND MEDICINES REGULATORY AUTHORITY

ARRANGEMENT OF SECTIONS

    SECTION

PART I
PRELIMINARY

    1.    Short title

    2.    Interpretation

PART II
THE PHARMACY AND MEDICINES REGULATORY AUTHORITY

    3.    Establishment of the Authority

    4.    Functions of the Authority

    5.    Powers of the Authority

    6.    Members of the Authority

    7.    Tenure of office and vacancy

    8.    Filling of casual vacancies

    9.    Proceedings during meetings of the Authority

    10.    Honoraria of members

    11.    Confidentiality

    12.    Disclosure of interest

    13.    Funds of the Authority

    14.    Financial year of the Authority

    15.    Accounts and audit

    16.    Annual report

    17.    Committees of the Authority

    18.    Director General and other staff

    19.    Delegation to the Director General

    20.    Seal of the Authority

    21.    Immunity

PART III
REGISTRATION AND REGULATION OF PHARMACISTS, PHARMACY TECHNOLOGISTS, PHARMACY ASSISTANTS AND MEDICAL REPRESENTATIVES

    22.    Registration of persons under this Act

    23.    Residential requirements of applicants

    24.    Persons eligible to be registered under this Act

    25.    Procedure for registration

    26.    Certificate of registration

    27.    Application for retention of name on register

    28.    Removal of name from the register

    29.    Notification of registration and removal from register

    30.    Appeals against refusal to register or against removal from register

    31.    Display of certificate in practice premises

    32.    Registration of premises

    33.    Company conducting wholesale or retail pharmacy business

    34.    Representatives of deceased or insolvent pharmacists

    35.    Exemptions from this Part

    36.    Pharmacy Committee

    37.    Performance of disciplinary function

    38.    Loss of certificate of registration

    39.    Registration of medical representatives

PART IV
REGISTRATION AND REGULATION OF PHARMACY PRACTICE PREMISES

    40.    Prohibition of unregistered pharmacy practice premises

    41.    Application for a licence

    42.    Issuance of a licence

    43.    Rejection of application

    44.    Display of licence

    45.    Retention fees

    46.    Surrender of a licence

    47.    Transfer of a licence

    48.    Amendment of a licence

    49.    Loss of a licence

    50.    Standard of pharmacy practice

    51.    Management of hospital and retail pharmacies

    52.    Dispensing licence

    53.    Veterinary shop licence

    54.    Register of pharmacy practice premises

    55.    Publication of premises

PART V
LICENCES, IMPORT AND EXPORT PERMITS

    56.    Prohibition of certain operation without a licence

    57.    Pharmaceutical manufacturing licence

    58.    Import permit

    59.    Export permit

    60.    Additional permit requirements for narcotics, etc.

    61.    Register of licences and permits

PART VI
REGULATION AND REGISTRATION OF MEDICINES AND ALLIED SUBSTANCES

    62.    Marketing authorization

    63.    Categories of medicines

    64.    Medicines list

    65.    Prohibition of sale of prescription only medicines without prescription

    66.    Labeling of medicine

    67.    Sale of medicine, etc.

    68.    Advertising of medicines

    69.    Recall of medicine, etc. from circulation

    70.    Medicines Safety and Quality Monitoring Committee

    71.    Register of marketing authorizations

    72.    Establishment of national pharmacovigilance system

    73.    Medicine Committee

PART VII
REGULATION OF CLINICAL TRIALS

    74.    Prohibition of conducting clinical trial without certificate

    75.    Application for clinical trial certificate

    76.    Granting of clinical trial certificate

    77.    Monitoring, inspection and reporting of clinical trial

    78.    Register of clinical trial certificates

PART VIII
THE NATIONAL MEDICINES QUALITY CONTROL LABORATORY

    79.    Establishment of National Medicines Quality Control Laboratory

PART IX
INSPECTIONS

    80.    Inspectors and inspections

PART X
OFFENCES AND PENALTIES

    81.    Contempt of the Pharmacy Committee

    82.    Theft of medicines or allied substance

    83.    Failure to keep proper records

    84.    Issuing false prescription of medicines

    85.    Unregistered dealer, product or premises

    86.    Conducting pharmacy business on unlicensed premises

    87.    Assembling, importing, selling, etc., medicinal product without product licence

    88.    Penalty for contravening sections 85, 86 and 87

    89.    Failure to comply with a manufacture’s licence

    90.    Failure to comply with a wholesale dealer’s licence

    91.    Managing retail pharmacy practice without a licence

    92.    Failure to comply with a dispensing licence

    93.    Failure to comply with a medicine store licence

    94.    Clinical trial without protocols and regulatory approvals

    95.    Non-compliance with requirements on medicine schedules

    96.    Import or export without permit

    97.    Modification of a product without approval

    98.    Sale of falsified or substandard medicine

    99.    No labeling of product

    100.    Sale of product with wrong leaflet or package insert

    101.    Disregard for prohibited advertisements

    102.    Miscellaneous offences and penalties

    103.    Additional penalties

    104.    Manufacture, import, export, etc., of substandard substances

    105.    Sale of expired medicines

    106.    Misleading information

    107.    Sale of dangerous cosmetics

    108.…