Balance diet and physical activities make you smart & healthier.
- If you need a supplement clearly identify your need.
- Check the registration status of the product with NMRA.
- Check the labels before you buying a supplement.
Definition
“Borderline products” are products having combined characteristics of medicines along with foods, medical devices or cosmetics.
The following criteria shall be taken into consideration when evaluating borderline products for registration :
- The intended use of the product (or its primary function) and its mode of action
- The therapeutic claims made by the manufacturer regarding the product in terms of it’s ability to treat or prevent diseases
- Pharmacologically active substance(s), if any, used in the product.
- The concentration of the active substances
- The level of efficacy of the active substance of the product
- The ingredients used and the concentrations at which they are used.
According to the National Medicines Regulatory Authority Act No. 05 of 2015 the National Medicines Regulatory Authority shall be responsible for the regulation and control of registration, licensing, manufacture, importation and all other aspects pertaining to borderline products;
The Borderline Products Evaluation Committee (BPEC) will carry out the technical evaluation of products submitted for registration and assist the Authority to regulate and control all aspects pertaining to borderline products.
Scope and Responsibilities of the NMRA in the approval of borderline products
The National Medicines Regulatory Authority (NMRA) is responsible to build a healthier nation by ensuring the availability of quality and safe borderline products in Sri Lanka. As such all products which may come under Borderline Product category should be registered with the Authority.
All foreign borderline products manufactures should submit application for registration through a Marketing Authorization Holder (local agent) in Sri Lanka who shall be responsible for the registration, licensing, importation, sale and distribution, handing of quality failures and all aspects pertaining to the particular medical device in Sri Lanka.
The product registration process is in two steps:
I. Preliminary evaluation (Product classification) –Valid period (only 1 year)
II. Product registration- Valid period ( 1 year, 2 year or 5 years)
Local agent profile creation and obtaining a Preliminary evaluation report (Product classification report) are mandatory requirements to initiate the product registration process, and application submission should be done through eNMRA facility.
Except in Preliminary evaluation (Product classification) and profile creation all the other applications should be submitted manually.
Obtaining formulation approval is mandatory requirement before submitting the registration dossier to the NMRA This is applicable for only local manufactures.
Common product types
1.Multi vitamins & multi minerals
2.Multivitamins
3.Glucosamine only products
4.Pro & Prebiotics
5.Glucosamine combinations
6.Coenzyme Q10 products
7.Glutathione containing products (oral dosage forms)
8.Enzyme containing products
9.Herbal & multivitamin combinations
10.Medicated toothpastes (Special toothpastes containing Potassium Nitrate and other salts)
11.Sun protection creams (SPF value > 30)
12.Fish oil products
13.Amino acid containing products
14.Preparation containing collagen peptides, cartilages, bone particles, etc
Required documents:
- Preliminary evaluation (product classification).
- Formulation approval (Applicable only for local manufacturers)
- Sample import license (Applicable only for foreign manufacturers)
- Application form for sample import license
- Product registration (Local)
- Product registration (Foreign)
Required documents for “Preliminary evaluation (Product Classification)” under Borderline Category National Medicines Regulatory Authority
- Covering letter including contact details of the local agent (e-mail address, phone numbers, address)
- Copy of Letter of Authorization from the manufacturer which addressed to Director General, NMRA
- Formulation (for a device-not applicable)
- Copy of Free Sale Certificate /COPP/ or a certificate to prove the registration status in country of origin(Not applicable for local manufacturer)
- Copy of Certificate of Analysis for Finish Product
- Specimen coloured label, Packaging materials ( art work acceptable)
- Clinical evidences for claims
- Legible product information leaflet
- Patient information leaflet, Promotional materials(If applicable)
All applicants who submit applications under Borderline products should submit the composition of unit dose along with the batch manufacturing formula.
Amount of all active ingredients per unit dose should be given in the form of vitamin or mineral and units according to the "Guideline on Product categorization Reference details Vitamins & Elements"
Examples:
- Minerals in elemental level (Na but not as Sodium chloride)
- Vitamins (Vitamin A but not as retinol, beta-carotene, etc)
- Units (Vitamin D in μg/day, Zn in mg/day)
All noncompliant applications with above will be rejected with effect from 13th of July 2020.
Validity period of Prelimineray Evaluation Report (Classification report) is one year and product registration dossiers should be submitted within the validity period of the Classification report.
Required Documents for formulation approval (local)
- Preliminary evaluation report (Classification report)
- Covering letter
Required documents for applying Sample Import Licence for Borderline Products National Medicines Regulatory Authority
- Preliminary evaluation report (Classification report) issued by NMRA with the approved formulation.
- Application for a Licence to import a limited Quantity of any Borderline Product(s) for Testing, Examination, Distribution, Sample Analysis or Clinical Trial
- Copy of Business Registration Certificate.
- Copy of Letter of Authorization from the manufacturer which addressed to Director General, NMRA (If more than one local agent present, the list of local agents provided by the manufacturer).
- Catalogue (If a device)
- Copy of Free Sale Certificate /Copy of COPP
- Specimen coloured label and packaging materials.
Required documents for product registration (local).
- Business registration certificate.
- Preliminary GMP report or GMP certificate/ISO certificate.
- Preliminary Evaluation report.
- If New-formulation approval letter.
- If Re Registration-Previous Registration certificate.
- Letter of Authorization from the manufacturer which addressed to DG/NMRA (If applicable)
- Wholesale License (If available).
- Registration certificates of other countries
- Manufacturing formula with batch size and master formula with function of each ingredient
- Manufacturing process with process flow diagram clearly.
- Manufacturing process validation report for three consecutive commercial batches (If applicable).
- Certificate of analysis for finished Product/Finish product test-report with specifications.
- Finish product test specifications (If applicable)
- Analytical validation report (if applicable).
- Stability data for 3 commercial batches (If applicable).
- Published Clinical trial data for finish product (If applicable).
- Catalogue (If applicable).
- Approved Product Information Leaflet (If applicable).
- Patient Information Leaflet (If applicable).
- Promotional Material (If applicable).
- Packaging materials- Specimen coloured label & six side displayed secondary package (If applicable).
- Specifications & Certificates of Analysis of Packaging materials.
- API certificates (If applicable).
- API GMP compliance certificates (If applicable).
- Certificates of excipients (If applicable).
- Two samples (If applicable).
- Post marketing data (If applicable).
Required Documents for product registration (Foreign).
- Business registration certificate.
- Free Sale certificate or COPP.
- GMP certificate/ISO certificate.
- Manufacturing site approval letter (If applicable).
- Preliminary Evaluation Report (Classification Report).
- If New- Sample Import License.
- If Re Registration -Previous Registration certificate.
- Letter of Authorization from the manufacturer which addressed to DG/NMRA (If more than one local agent present, the list of local agents provided by the manufacturer).
- One local agents present for the same manufacturer, the list of local agents to be included to the letter).
- Registration certificate of other countries.
- Wholesale License (If applicable).
- Manufacturing formula with batch size and master formula with function of each ingredient.
- Manufacturing process with process flow diagram clearly.
- Manufacturing process validation report for three consecutive commercial batches (If applicable).
- Certificate of analysis for finished product/Finish product test-report with specifications.
- Finish product test specifications (If applicable)
- Analytical validation report (if applicable).
- Stability data for 3 commercial batches (if applicable).
- Published Clinical trial data for finish product (If applicable).
- Catalogue (If applicable).
- Approved Product Information Leaflet (PIL) by the NMRA
- Patient Information Leaflet (If applicable).
- Promotional Material (If applicable).
- Packaging materials- Specimen coloured label & six side displayed secondary package(If applicable).
- Specifications & Certificate of Analysis of Packaging materials.
- API certificates(If applicable).
- API GMP compliance certificates(If applicable).
- Certificates of excipients(If applicable).
- Two samples(If applicable).
- Post marketing data(If applicable).
- Post marketing data-In SL(If applicable only).
- Preliminary evaluation (product classification)
