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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.
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.
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
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)
An applicant for marketing authorization 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.
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.
Submission of Registration Application
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
Changes may be required to the content of particulars related to the medicine that were submitted at the time of applying for registration, due to various reasons such as technical and scientific advances, new findings that affects its quality, safety, efficacy, or simply changes of administrative nature. Marketing authorization holder is legally bound to inform any such changes to the National Medicines Regulatory Authority.
Regulation 16 of the Medicine Regulations No. 2145/1 of 14.10.2019 requires the marketing authorization holder to comply with variation guidelines published by NMRA, and to inform forthwith the following:
For multisource products, ‘Guideline for Variations of Medicines’ published by NMRA applies
Marketing authorization holders for relevant products are required to submit a variation application to NMRA with the prescribed form when there is any material change, procedural change, change to labeling, any other changes that would affect product’s quality, safety, or efficacy.
Variations are categorized as follows;
Major Variations (MAV)
Proposed changes that may affect directly and/or significantly the aspects of its quality, safety and efficacy of a registered medicine and they do not fall within the definition of a minor variation or a new registration. Prior to implementation of such changes, approval of the NMRA is necessary
Minor variations requiring approval (MIV1)
Proposed changes may have minimum impact on the quality, safety, and efficacy of a registered medicine. NMRA approval for the change is still required prior to implementation.
Minor variations requiring notification (MIV2)
These changes are mainly of administrative nature with no significant impact on quality, safety, and efficacy of the registered medicine. Marketing authorization holder requires only notifying the change to the NMRA.
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.
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
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.
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.
NB: Once registration is granted; variations are also managed through WHO collaborative procedure.
Reference:https://extranet.who.int/prequal/content/collaborative-registration-faster-registration
Lot release of vaccines & sera during the period of 01.01.2023 to 30.06.2023
Vaccines released by NCL - year 2019
Lot Releases (From 01 - 07 - 2019 to 31 - 12 - 2019
Reference National Regulatory Authorities Identified for Market Authorization of Medicines
Reference National Regulatory Authorities Identified for Market Authorization of Vaccines and New Molecule Entities
If a particular medicine required by a patient is not registered or not available in Sri Lanka, NMRA allows import of such a medicine through a personal user Letter of Authorization. The general public can apply for a personal user license by logging into https://www.enmra.nmra.gov.lk furnishing required details or by handing over the documents directly to NMRA during working hours.
The following documents are required:
A maximum of 100 doses can be imported by using the Personal User License. No fee is charged by NMRA for this purpose.
A person travelling to Sri Lanka can carry medicine for his personal use, without prior approval of the NMRA under the following conditions. The quantity of any single medicine required for the duration of his stay in Sri Lanka or the quantity required up to ninety days whichever is less. Prior approval of the NMRA should be obtain for quantities exceeding 90-day requirement. The medicine administered through intramuscular or intravenous route is not permitted. The medicine specified in Schedule III is not permitted. The medicine should be packed in the original container, if it is not in the original container, it should be appropriately labelled to identify the name and strength of the medicine with usage instructions Medical records or prescription should be produced when necessary.
Approval of Foreign Manufacturing Facilities
Introduction & Scope:
The process applies for overseas manufacturing sites who intended to get marketing authorization for their products in Sri Lanka. The procedure includes a desk review of essential documents including the site master file. A GMP inspection of the site may be necessary before approval of the site.
A foreign manufacturer who wants to register products in Sri Lanka needs to appoint a Sri Lankan business entity as its local authorized agent. The local agent will furnish applications on behalf of its principal company, the foreign manufacturer. A separate application needs to be submitted to each manufacturing site from which the manufacturer plans to export products to Sri Lanka.
Application has to be submitted online via NMRA’s web portal eNMRA which requires uploading of essential information and documents to enable a desk review. If all documents indicate fulfilment of NMRA requirements, the next step would be to carry out a GMP inspection of the facility. The NMRA Act, No. 5 of 2015 (section 51) & regulations 2 to 10 of part I of medicines regulations pronounce the legal requirements. The NMRA would exempt onsite GMP inspection if the particular site had been inspected by a stringent NRA or WHO, in terms of regulation 24 of the medicines regulations. After these procedures, an approved foreign manufacturer can submit an application for marketing authorization of its products through the local agent.
Flow Chart- Foreign Manufacturing Site Approval
The process applies for local manufacturing sites who intended to get marketing authorization for their products in Sri Lanka. The procedure includes a desk review of essential documents including the site master file and several GMP Inspections.
A local manufacturer who wants to register products in Sri Lanka needs to furnish applications regarding his manufacturing facilities. A separate application needs to be submitted to each manufacturing site.
Application has to be submitted online via NMRA’s web portal eNMRA which requires uploading of essential information and documents to enable a desk review and GMP Inspections.
The NMRA Act, No. 5 of 2015 (section 51) & regulations 26 to 30 of part II of medicines regulations pronounce the legal requirements.
After these procedures, an approved Local manufacturer can submit application for formulation approvals.
After obtaining the formulation approval and GMP approval for commercial manufacturing of the facility, local manufacturer can apply for the product registration. After that, local manufacturer can apply for the manufacturing license.
Site Master Files are submissions to NMRA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of Medicines, Medical Devices, Borderline products and cosmetics.
Guidance for Site master Files
References:
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
The National Medicines Regulatory Authority Act No. 5 of 2015 interprets GMP guidelines as ‘good manufacturing guidelines issued by the World Health Organization’. As such, the National Medicines Regulatory Authority (NMRA) adopts the WHO GMP guidelines along with its subsequent updates for the purpose of regulation of pharmaceutical manufacture. The manufacturers are expected to adhere to the Good Manufacturing Practices throughout their activities.
Pharmaceutical manufacturers who intend to apply for marketing authorization in Sri Lanka may be subjected to one or several GMP inspections prior to their site approvals.
GMP Guidelines available on WHO website:
WHO good manufacturing practices for pharmaceutical products: main principles:
https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf?ua=1
WHO good manufacturing practices for sterile pharmaceutical products:
WHO good manufacturing practices for biological products:
https://www.who.int/publications/m/item/annex-2-WHO-gmp-for-biological-products
Guideline on Approval of an Overseas Manufacturing Plant of Medicines
Guideline on Preparation of Site Master Files
Guideline for preparation and conduct of the GMP inspection
Healthcare professional such as doctors, dentists, pharmacists and nurses are encouraged to report suspected adverse events encountered in their day to day practice.
Using the ADR google form given by the following link here, you can report Adverse Events.
Adverse Drug events reporting
Address
Director General / CEO
National Medicines Regulatory Authority,
No: 120,
Norris Canal Road,
Colombo 10.
Telephone
+94 112 698 896, +94 112 698 897
Fax
+94 112 689 704
A copy of the form shall be forwarded to Adverse Drug Reaction Monitoring Unit of the Department of Pharmacology, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08. (TP/ Fax: +94 112 697 483).
When a new chemical entity (NCE) is first marketed, it would have been tested only in a limited number of patients/volunteers. Rare adverse drug reactions/events could be identified only after the drug is marketed and used by a much larger population. Safety information in use in special groups such as children, elderly, pregnant women etc. are not often available at the time of first marketing of a new drug.
The Advertising Evaluation Sub Committee of the NMRA regulates advertisements - printed and electronic material - related to medicines, devices, borderline products to ensure such advertisements are ethical, accurate and appropriate.
Working definition & general rules
Advertisement includes any representation by any means whatsoever, for the purpose of promoting directly or indirectly the manufacture, sale or disposal of any medicine, medical device, borderline product.
Our Scope & Responsibility
Procedure for applying approval for advertisements
All the applicants who which to obtain approval for the advertisement on medicines, medical device and borderline products should be followed below procedure.
1. Submit the duly filled application (Please mention email address correctly for sending evaluation sheet) along with copy of valid registration certificate, story board of the advertisement to the accepting counter on every Friday (From 9.00 am to 3.30 pm)for obtaining the payment note for processing fee (1000USD).
2. Payment Receipt issued by account division should be submitted to NMRA after the payment along with the application with following documents to accepting pharmacist (Every Friday from 9.00 am to 3.30 pm). Application should be submitted in a file. Accepting pharmacist accepts the application and assign a reference number.
Documents Needed to be enclosed with the application :-
3. All the applications will be tabled to the committee (Once a month) and evaluation reports will be emailed to the applicants.
4. Approved letters can be collected from the issuing counter.in the advertisements
Applicants should consider the following when designing an advertisement:
Application for license to Import Medicine
Archived guidelines
Dollar rates are converted at the selling rate on last working day of the preceding month (30.11.2024) which was published by the Central Bank of Sri Lanka.
(I) Processing Fees,(II) Fees for additional data evaluation,(III) Processing fees for Clinical Trial,(IV) Fees for Certificates of Registration,(V) Fees for License,(VI) Fees for Other Approvals,(VII) Fees for Analysis,(VIII) Fees for License to deal in Medicines in Retail Pharmacies, Wholesale Establishments and Transporting of Medicines,(IX) Fee for Good Manufacturing Practice Inspection (GMP) - Local,(X) Fee for Good Manufacturing Practice Inspection (GMP) - Foreign,(XI) Fee for sample import license for clinical trials,(XII) Fee for Advertisement
Under section 109 of National Medicines Regulatory Authority Act. No.5 OF 2015,the Authority may grant permission in special circumstances to import and supply a particular pharmaceutical product in specified quantities of an unregistered medicine under a waiver of registrations approval. The special circumstances include medicine used to save a life, to control an infection or an epidemic or may other national emergency or for national security.
Applicants should submit the filled and signed Application from for waiver of registration to the NMRA along with the recommendation of the Ministry of Health
Importers should refer the guideline for the WOR of pharmaceutical products imported into Sri Lanka.
After receiving approval, the applicant shall submit the importation details to the NMRA within 28 calendar days of importation by filling the Notification of importation from.
(Above procedure effects from 15 November 2024)
Note: Incomplete application will not be tabled to WOR Committee.
Issued Waiver of Registration - Medicines, Approved by the 59th Medicines Evaluation Committee
All dossiers & related documents for medicine registration will be accepted after applying by filling the Google form through the link or the QR code below.
Fill the following checklist and submit two copies with the dossier to the accepting point.
Effective from 27 September 2024, all market authorization holders are required to submit their eCTD dossiers using the following Google Form. This submission is in addition to the hard copy dossier submission.
Important Instructions :
Rename the eCTD dossier : Before submitting, please rename your eCTD dossier according to the dossier number received from the accepting counter.
Submission Deadline : Ensure that both the eCTD and hard copy dossiers are submitted by the specified deadlines.
National Medicines Regulatory Authority,
State Engineering Corporation Building (2nd Floor),
No. 130,
W.A.D Ramanayaka Mawatha,
Colombo 02,
Sri Lanka