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 ; and
- 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 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.
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
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 200,000 IU / ML INJECTION
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
Step 1 - Approval of new manufacturer for registering medicines
- An application to be submitted for approval of the manufacturing site. If the manufacturer is from a foreign country, a local company authorized to represent the manufacturer should be appointed and all applications should be furnished through the aforesaid local agent.
- Upon approval of the manufacturing site, an application for registration of the medicines which are manufactured by the pertinent manufacturer should be submitted.
Step 2 - Registration of Medicines
Types of Application : Medicines are broadly subdivided into the following categories for the submission of applications for approval
A Chemical moiety which has not been previously registered in Sri Lanka, including an active ingredient of a salt, an ester or complex of a previously approved Chemical moiety
Any physical form of a registered medicine in Sri Lanka other than the available registered forms
A new combination product is a formulation of two or more medicines in a single dosage form which has not been previously registered in Sri Lanka
Any new product of already registered medicine in Sri Lanka
- Vaccines & Sera (Guidelines for Handling and Storage of Vaccines in the Private Sector)
- Plasma products
- Bio-technological products
- Other biological products
The applicant for marketing authorization (i.e. the local manufacturer or the local importer representing the manufacturer) should submit an application (Documents required) in the format given in the Schedule IV, Form A of CDD Regulations with drug samples to the National Medicines Regulatory Authority (NMRA). Prior to submitting the application, a sample license needed to be obtained from the NMRA in order to facilitate customs clearance when importing the registration samples.
Guidelines on Evaluation of Similar Bio therapeutic Products (SBPs)
Marketing Authorization of Medicines through WHO collaborative registration procedure
Since 2017, NMRA of Sri Lanka has been listed in the WHO/PQ website as a Drug Regulatory Authority participating in the collaborative registration procedure of the World Health Organization, which allows WHO pre-qualified medicines including vaccines to enter the Sri Lankan market through a fast-track and verification procedure.
Prerequisites:
• The manufacturer should be an approved entity in Sri Lanka. If not, the manufacturer should find a suitable Sri Lankan pharmaceutical company as its authorized agent and apply through such authorized agent to be an approved manufacturer.
• The manufacturer should indicate its intent of applying through the collaborative registration procedure to both NMRA and WHO and should give its consent for the WHO to share all relevant review reports, inspection reports and lab testing results etc. with the focal points of the NMRA.
Commitment of the NMRA
• NMRA once committed to accept an application for marketing authorization through the procedure, undertakes to give its decision on the relevant application within a timeline of 90 days, subjected to stop-clocks.
• NMRA agrees to treat any information provided by WHO/PQ team through its access-restricted website as confidential and proprietary to WHO/PQT, and to use such information only for the purpose, and to make no other use thereof.
Procedure
The steps below are product specific and are triggered by the applicants / manufacturers through a submission of an application to register a prequalified in Sri Lanka.
1. Manufacturer/ Applicant: A manufacturer who is interested in marketing one of its pre-qualified products in Sri Lanka should submit an expression of interest via email to WHO by sending completed Appendix 2. The applicant also submits completed Appendix 3A to NMRA, Sri Lanka. (These appendices are formats given by WHO)
2. NMRA: Once the request from manufacturer is received, NMRA has the option to agree or decline to use the procedure for that specific product. The decision of the NMRA will be conveyed to the applicant as well as to WHO. If NMRA declines to use the procedure, reasons for such decision should be indicated.
3. Manufacturer/ Applicant: Once NMRA agrees to accept the application through the procedure, the complete dossier is submitted to NMRA through his authorized agent in Sri Lanka.
4. WHO: Proceeds to give focal points of the NMRA access to the specific folder with confidential information about that specific product (WHO prepared assessment reports and inspection reports).
5. NMRA: The focal points can download these reports and use them for review processes / decision making. The timeline for decision making is 90 days subjected to stop clocks.
NB: Once registration is granted, variations are also managed through WHO collaborative procedure.
Reference:https://extranet.who.int/prequal/content/collaborative-registration-faster-registration
An applicant for marketing authorisation of medicine is required to submit minimum two packs representative of commercial packs he intend to market in Sri Lanka, along with the application for marketing authorization. If the manufacturer is from overseas, a sample license from NMRA would be required in order to facilitate customs clearance when importing such registration samples.
The following documents are required to be furnished by the applicant along with the application (Schedule XI) for import of registration samples.
- Request letter for a sample license by the applicant
- Letter of authorization by the manufacturer indicating the applicant as his local agent
- Letter of approval for the manufacturing site by NMRA (CP approval letter)
NMRA reserves the right to refuse to issue a sample license to a particular product. Currently NMRA does not accept applications if there are twenty or more registered products of the particular item.
Once the applicant obtains the sample license, he is required to abide by the condition of the license, which is specified in relevant regulations. Particularly, the applicant should maintain all records pertaining to goods imported on such sample licenses.
Import of registration samples
Flow chart
Figure 1: Registration of NP Applications
The certificate of registration is valid for 5 years. Under specific circumstances (e.g. when the drug is a new chemical entity, the manufacturer is new to this country) a provisional registration will be issued first, which is valid for one or two years.
A renewal application in Schedule IV form A and other documents required should be submitted 6 months before expiration of the existing registration.
Any changes (variation) of registered medicine should be informed to NMRA, NME, NDF, NCP
Figure2 : Registration of NMEs, NDF & NCPs
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