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Regulatory Overview

This section explains what is termed as a medicine and their different categories.

Information is also given to provide guidance on the type of applications and how to apply for the approval of medicines that can be made available for use in Sri Lanka.

Definition of a medicine:
  • Any substance or mixture of substances manufactured, sold, offered for sale or represented for use in -
    • The diagnosis, treatment, mitigation or prevention of disease, abnormal physical states or the symptoms thereof in man or animal.
    • Restoring, correcting or modifying functions of organs in man or animal
  • A medicine or combination of medicine ready for use and placed on the market under a special name or in a characteristic form, both patent and non-proprietary preparations;
  • A product made out of medicinal herbal extract;
  • Nutraceutical with therapeutic claims; and
  • Vaccines and sera,
  • but does not include an Ayurvedic medicine or a Homoeopathic medicine;
The Scope & Responsibilities of the NMRA in the approval of Medicines

The NATIONAL MEDICINES REGULATORY AUTHORITY ACT, No. 5 OF 2015 provides the authority to the NMRA to regulate all aspects pertaining to medicines.

National Medicines Regulatory Authority (NMRA) will thereby regulate and control manufacture, importation, storage, distribution, transportation, pricing, wholesale and retail sale, advertising, and disposal of medicines to ensure that medicines made available in the country are of good quality, efficacious, safe, and affordable.

The National Medicines Regulatory Authority Act specifies that no person shall manufacture or import any medicine without registering such medicines with the NMRA.

The Medicines Evaluation Committee (MEC) formed under NMRA Act will use registration and certification procedures to carry out scientific and technical reviews, inspections and surveillance activities of the medicines forwarded for registration to ensure the quality, efficacy, safety, need and cost of such medicines. The MEC consist of experts drawn from various specialties in medical and pharmaceutical fields who meets monthly to decide on applications submitted for marketing authorization of medicines and to make policy decisions relevant to marketing authorization of medicines.

NMRA grants Priority review to following Products
  • ABACAVIR SULFATE 60 MG + LAMIVUDINE 30 MG TABLETS
  •  ABACAVIR TABLETS 300 MG
  •  ABCIXIMAB INJECTION 2 MG / ML
  •  ACETAZOLAMIDE INJECTION 500 MG
  •  ACETYLSALICYLIC ACID TABLETS 300 MG
  •  ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION 250 MG
  •  ACITRETIN CAPSULES / TABLETS 10 MG
  •  ACTINOMYCIN D INJECTION 500 MCG
  •  ADALIMUMAB INJECTION 40 MG / 0.8 ML
  •  ADENOSINE INJECTION USP 3 MG / ML
  •  ADRENALINE INJECTION SYRINGE AUTO INJECTION 0.15MG / 0.3 ML, 0.3 MG / 0.3 ML
  •  ALBENDAZOLE ORAL SOLUTION USP 200 MG / 5 ML
  •  ALLOPURINOL TABLETS 100 MG
  •  ALLYLESTRENOL TABLETS 5 MG
  •  ALPROSTADIL INJECTION USP 0.5 MG / ML
  •  ALTEPLASE (RECOMBINANT HUMAN TISSUE TYPE PLASMINOGEN ACTIVATOR INJECTION 20 MG / 50 MG
  •  AMANTADINE CAPSULES 100 MG
  •  AMIKACIN SULPHATE INJECTION BP 500 MG / 2 ML, 250 MG / 2 ML, 100 MG / 2 ML
  •  AMILORIDE HYDROCHLORIDE 5 MG + HYDROCHLOROTHIAZIDE 50 MG TABLETS
  •  AMINOPHYLLINE INJECTION 25 MG / ML
  •  AMISULPRIDE TABLETS 100 MG, 200 MG, 300 MG
  •  AMITRIPTYLINE HYDROCHLORIDE TABLETS 25 MG, 10 MG
  •  AMPHOTERICIN B FOR INJECTION 50 MG
  •  ANIDULAFUNGIN FOR INJECTION 100 MG
  •  ANTI HEMOPHILIC FACTOR-HUMAN INJECTION 220-2000 IU VIAL
  •  ANTI RABIES SERUM EQUINE 1000 IU IN 5ML
  •  ANTI RHO-D IMMUNOGLOBULIN INJECTION 300 MCG
  •  ANTI THYMOCYTE GLOBULIN EQUINE 250 MG / 5 ML
  •  ANTIHEMOPHILIC FACTOR VIII CONCENTRATED HUMAN INJECTION 250 IU
  •  ARTEMETHER 20 MG + LUMEFANTRINE 120 MG TABLETS
  •  ARTESUNATE FOR INJECTION 60 MG
  •  ATAZANAVIR CAPSULES 300 MG
  •  ATENOLOL INJECTION 5 MG / 10 ML
  •  ATOMOXETINE CAPSULES 10 MG, 25 MG
  •  ATRACURIUM BESYLATE INJECTION 25 MG / 2.5 ML
  •  ATROPINE EYE DROPS 1% W/V
  •  ATROPINE INJECTION BP 15 MG / 25 ML, 1 MG / 1 ML
  •  AZACITIDINE FOR INJECTION 100 MG / VIAL
  •  AZATHIOPRINE TABLETS 50 MG
  •  BALANCED SALT SOLUTION
  •  BARIUM SULPHATE FOR SUSPENSION
  •  BCG VACCINE
  •  BENDAMUSTIN HYDROCHLORIDE FOR INJECTION 100 MG VIAL
  •  BENZHEXOL TABLETS 2 MG
  •  BENZTROPINE MESYLATE INJECTION 1 MG / 1 ML
  •  BENZYL PENICILLIN FOR INJECTION 300 MG (500,000 U), 600 MG (1,000,000 U)
  •  BERACTANT INTRATRACHEAL SUSPENSION 200 MG in 8 ML
  •  BICALUTAMIDE TABLETS 150 MG
  •  BLEOMYCIN FOR INJECTION 15 UNIT
  •  BOTULINUM TOXIN TYPE A 100 U / 50 U
  •  BROMAZEPAM 1.5 MG / 3 MG
  •  BUPIVACAINE INJECTION 0.5%
  •  BUSPIRONE HYDROCHLORIDE TABLETS 20 MG
  •  CABAZITAXEL INJECTION 60 MG / 1.5 ML WITH SOLVENT
  •  CABERGOLINE TABLETS 0.5 MG
  •  CANAGLIFLOZIN TABLETS 100 MG
  •  CARBAMAZEPINE Tablets 100 mg, 200 mg / Syrup 100 MG / 5 ML
  •  Carbergoline Tablets BP 500 mcg
  •  CEFEPIME FOR INJECTION 1 G, 500 MG
  •  CeEFOTAXIME FOR INJECTION 1 G, 500 MG, 250 MG
  •  CEFPIROME FOR INJECTION 1 G
  •  CEFTAZIDIME FOR INJECTION 500 MG
  •  CEFTRIAXONE FOR INJECTION 250 MG, 500 MG
  •  CEFUROXIME SODIUM FOR INJECTION 1.5 G, 250 MG
  •  CERITINIB CAPSULES 150 MG
  •  CETUXIMAB SOLUTION FOR INJECTION 5 MG / ML
  •  CHLORAMBUCIL TABLETS 2 MG
  •  CHLORAMBUCIL TABLETS BP 5 MG, 2 MG
  •  CHLORAMPHENICOL CAPSULES 250MG
  •  CHLORAMPHENICOL SODIUM SUCCINATE INJECTION 1 G, 500MG
  •  CHLORDIAZEPOXIDE TABLETS 10 MG / 5 MG
  •  CHLOROQUINE PHOSPHATE TABLETS 250 MG
  •  CHLORPHENIRAMINE MALEATE INJECTION 10 MG / ML
  •  CHLORPROMAZINE HYDROCHLORIDE 25 MG / 50 MG
  •  CHLOTHALIDONE TABLETS 6.25 MG
  •  CHOLECALCIFEROL TABLETS 400IU
  •  CHORIOGONADOTROPIN INJECTION
  •  CICLOSPORIN CAPSULES 25 MG, 50 MG, 100 MG / EYE DROPS 0.1% / ORALS SOLUTION 100 MG / ML
  •  CILNIDIPINE TABLET 5 MG / 10 MG
  •  CILOSTAZOL TABLETS USP 50 MG / 100 MG
  •  CITALOPRAM HYDROBROMIDE TABLETS 10 MG / 20 MG
  •  CLOBAZAM TABLETS 5 MG
  •  CLOFAZIMINE TABLETS 100 MG
  •  COAGULATION FACTOR IX (HUMAN)
  •  CORTICOTROPHIN CARBOXYMETHYLCELLULOSE INJECTION 60 IU / ML
  •  CO-TRIMOXAZOLE ORAL SUSPENSION IP 240 MG / 5 ML
  •  CRISANTAPASE INJECTION 10000 U
  •  CYCLOPHOSPHAMIDE FOR INJECTION BP 100 MG / 200 MG / 500 MG / 1000 MG
  •  CYCLOPHOSPHAMIDE Tablets ALL STRENGTH
  •  CYCLOSERINE CAPSULES 250 MG
  •  CYTARABINE INJECTION BP 100
  •  MICONAZOLE 2% + HYDROCORTISONE 1% CREAM
  •  POVIDONE IODINE CREAM
  •  PRAZOSIN 2.5 MG/ 5MG TABLETS
  •  TRICLOFOX ORAL SOLUTION 500 mg/5 ml
Details
120, Norris Canal Road, Colombo 10
 011-2687743
 info@nmra.gov.lk
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