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
- Multi vitamins & multi minerals
- Multivitamins
- Glucosamine only products
- Pro & Prebiotics
- Glucosamine combinations
- Coenzyme Q10 products
- Glutathione containing products (oral dosage forms)
- Enzyme containing products
- Herbal & multivitamin combinations
- Medicated toothpastes (Special toothpastes containing Potassium Nitrate and other salts)
- Sun protection creams (SPF value > 30)
- Fish oil products
- Amino acid containing products
- 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 product classification
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 colored 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 Preliminary 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)
Required documents for “Preliminary evaluation (Product Classification)” under Borderline Category National Medicines Regulatory Authority
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"
All noncompliant applications with above will be rejected with effect from 13th of July 2020.