gov lk

Required documents for “Preliminary evaluation (Product Classification)” under Borderline Category National Medicines Regulatory Authority

1.Covering letter including contact details of the local agent (e-mail address, phone numbers,
2. Copy of Letter of Authorization from the manufacturer which addressed to Director General,
3. Formulation (for a device-not applicable)
4. Copy of Free Sale Certificate /COPP/ or a certificate to prove the registration status in
country of origin (Not applicable for local manufacturer)
5. Copy of Certificate of Analysis for Finish Product
6. Specimen colored label, Packaging materials (art work acceptable)
7. Clinical evidences for claims
8. Legible product information leaflet
9. 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 &

o Minerals in elemental level (Na but not as Sodium chloride)
o Vitamins (Vitamin A but not as retinol, beta-carotene, etc)
o 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.

120, Norris Canal Road, Colombo 10