| 1.
| | This Act may be cited as the National Medicines Regulatory Authority Act, No. 5 of 2015 and shall come into operation on such date as the Minister may appoint by Order published in the Gazette (hereinafter referred to as "the appointed date"). |
| 2.
| | Establishment of the National Medicines Regulatory Authority. |
| 3.
| | Objects of the Authority. |
| 4.
| | Constitution of the Authority. |
| 5.
| | Chairman of the Authority. |
| 6.
| | Conflict of interests of the members. |
| 7.
| | Disqualifications to be a member. |
| 8.
| | Ex-officio members. |
| 9.
| | Provisions relating to appointed members. |
| 10.
| | Meetings of the Authority. |
| 11.
| | The Seal. |
| 12.
| | Authority to invite experts to meetings. |
| 13.
| | Remuneration for attending meetings of the Authority. |
| 14.
| | Powers and functions of theAuthority. |
| 15.
| | Appointment of the Chief Executive Officer of the Authority. |
| 16.
| | Staff of the Authority. |
| 17.
| | Public officers to be appointed to the Staff of the Authority. |
| 18.
| | Fund of the Authority. |
| 19.
| | Authority to maintain accounts. |
| 20.
| | Financial year and audit of accounts. |
| 21.
| | Investment of funds. |
| 22.
| | Borrowing powers of the Authority. |
| 23.
| | Annual Report. |
| 24.
| | Declaration of secrecy. |
| 25.
| | Delegation of powers of the Authority. |
| 26.
| | Directions by the Minister. |
| 27.
| | Officers and employees of the Authority deemed to be public officers. |
| 28.
| | Authority deemed to be a Scheduled institution. |
| 29.
| | Expenses in suit or prosecution to be paid out of the Fund. |
| 30.
| | Establishment of National Advisory Committee and divisions. |
| 31.
| | Constitution of the National Advisory Committee. |
| 32.
| | Chairman and c., of the National Advisory Committee. |
| 33.
| | Remuneration of the members of the National Advisory Committee. |
| 34.
| | Appointment of officers, employees and c |
| 35.
| | Functions of the National Advisory Committee. |
| 36.
| | Regulations. |
| 37.
| | Application of certain provisions of this Act in relation to National Advisory Committee. |
| 38.
| | Establishment of the National Medicines Quality Assurance Laboratory. |
| 39.
| | Functions of NMQAL. |
| 40.
| | Regulations. |
| 41.
| | Medicines Regulatory Division. |
| 42.
| | Functions of the MR Division. |
| 43.
| | Medicines Evaluation Committee. |
| 44.
| | Constitution of the MEC. |
| 45.
| | Panel of Experts. |
| 46.
| | Declaration of secrecy. |
| 47.
| | Authority to give general guidelines for the evaluation. |
| 48.
| | Application of certain provisions of this Act in relation to MEC. |
| 49.
| | Regulation of manufacture, importation, sale and distribution of medicine. |
| 50.
| | Labelling, and c.,to be in conformity with the prescribed standards. |
| 51.
| | Sale of prescribed medicine is prohibited unless premises and process of manufacture have been approved. |
| 52.
| | Sale of prescribed medicine prohibited unless the batch from which such medicine is taken approved
as reliable. |
| 53.
| | Sale and c., of prohibited medicine. |
| 54.
| | Possession of prohibited medicine. |
| 55.
| | Advertising, importation, sale and distribution of medicine as treatment for prescribed diseases prohibited. |
| 56.
| | Generic name of a medicine to be written in the prescription. |
| 57.
| | Contravention of the provisions of this Part to be an offence. |
| 58.
| | Requirement to register and c., of medicines. |
| 59.
| | Application for Registration of a medicine. |
| 60.
| | Registration of medicines. |
| 61.
| | Refusal of Registration. |
| 62.
| | Issuing of certificate of registration. |
| 63.
| | Issuing of licence. |
| 64.
| | Renewal. |
| 65.
| | Cancellation or suspension of registration and licence. |
| 66.
| | Medical Devices Regulatory Division. |
| 67.
| | Functions of the MDR Division. |
| 68.
| | Medical Devices Evaluation Committee. |
| 69.
| | Constitution of the MDEC. |
| 70.
| | Panel of Experts. |
| 71.
| | Declaration of secrecy. |
| 72.
| | Authority to give general guidelines for the evaluation. |
| 73.
| | Application of certain provisions of this Act in relation to MDEC. |
| 74.
| | Prohibition of importation and c., of medical devices other than the listed. |
| 75.
| | Regulation of manufacture, importation, sale and distribution of medical devices. |
| 76.
| | Prohibition of manufacturing, importation, assembling, sale and distribution and c., of medical
devices. |
| 77.
| | Labeling, packaging and advertising of medical device. |
| 78.
| | Prescribed standards of a medical device to be maintained. |
| 79.
| | Advertising, importation, sale and distribution of medical devices as a treatment for prescribed diseases
prohibited. |
| 80.
| | Possession of prohibited medical devices. |
| 81.
| | Contravention of the provisions of this Part to be an offence. |
| 82.
| | Requirement to register and c., of medical devices. |
| 83.
| | Application for Registration of a Medical device. |
| 84.
| | Registration of medical devices. |
| 85.
| | Refusal of Registration. |
| 86.
| | Application of the provisions of sections 62, 63,64 and 65. |
| 87.
| | Borderline Products Regulatory Division. |
| 88.
| | Functions of the BPR Division. |
| 89.
| | Borderline Products Evaluation Committee. |
| 90.
| | Constitution of the BPEC. |
| 91.
| | Panel of Experts. |
| 92.
| | Declaration of secrecy. |
| 93.
| | Authority to give general guidelines for the evaluation. |
| 94.
| | Application of certain provisions of this Act in relation to BPEC. |
| 95.
| | Prohibition of importation and c., of borderline products other than listed. |
| 96.
| | Regulation of manufacture, importation, sale and distribution of borderline products. |
| 97.
| | Where standard is prescribed for borderline products. |
| 98.
| | Advertising, importation, sale and distribution of borderline products for prescribed
diseases prohibited. |
| 99.
| | Possession of prohibited borderline product. |
| 100.
| | Contravention of the provisions of this Part to be an offence. |
| 101.
| | Requirement to register and c., of borderline products. |
| 102.
| | Application for Registration of a borderline product. |
| 103.
| | Registration of borderline products. |
| 104.
| | Refusal of Registration. |
| 105.
| | Application of the provisions of sections 62, 63,64 and 65. |
| 106.
| | Prohibition of dishonest dealings. |
| 107.
| | Authority to decide residual shelf-life of medicines and c. |
| 108.
| | Ban or withdrawal and c.,from, use of medicine and c. |
| 109.
| | Emergency and other special circumstances. |
| 110.
| | Sale or distribution of samples of medicine and c., to be prohibited. |
| 111.
| | Permission to import and to accept as a donation of any medicine and c. |
| 112.
| | Importation and c., of medicines and c., for personal use. |
| 113.
| | Licensing of premises for manufacturing and c., of medicine and c. |
| 114.
| | Conditions and c., pertaining to licence. |
| 115.
| | Establishment of the Manufacturing Regulatory Division. |
| 116.
| | Functions of the Manufacturing Regulatory Division. |
| 117.
| | Regulations. |
| 118.
| | Pricing of medicines and c. |
| 119.
| | Every person to carry on a Pharmacy to obtain a licence. |
| 120.
| | Requirement to comply with Good Pharmacy Practices. |
| 121.
| | Regulations. |
| 122.
| | Appeals. |
| 123.
| | The Appeals Committee. |
| 124.
| | Authorized Officers. |
| 125.
| | Powers of Authorized Officers. |
| 126.
| | Procedure in respect of articles and vehicles seized. |
| 127.
| | Authorized Officer to produce before court the part of the sample retained by him. |
| 128.
| | Copy or extract of document taken by an Authorized Officer. |
| 129.
| | Analysis. |
| 130.
| | General offences. |
| 131.
| | Punishment for the contravention of the provisions of this Act. |
| 132.
| | Person committing offence to be arrested without a warrant and to be tried by a
Magistrate's Court. |
| 133.
| | Where the accused proves that some other person is guilty of the offence. |
| 134.
| | Defence. |
| 135.
| | Presumptions. |
| 136.
| | Offence committed by body of persons. |
| 137.
| | Approved Analyst. |
| 138.
| | Report or certificate of the Approved Analyst or an Additional Approved
Analyst. |
| 139.
| | Priority for trial and appeal under this Act. |
| 140.
| | Application of other written laws. |
| 141.
| | Rules. |
| 142.
| | Regulations. |
| 143.
| | Institution of proceedings. |
| 144.
| | Repeal of Act,No. 27 of 1980. |
| 145.
| | Transitional provisions. |
| 146.
| | Interpretation. |
| 147.
| | In case of an inconsistency the Sinhala text shall prevail. |