NAtional Medicines Regulatory Authority

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Latest Announcements

Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v

December 12, 2025

Notice regarding transport license applications.

December 12, 2025

Mandatory Trilingual Labeling on Dispensing Envelopes and Containers

December 11, 2025

Rejected Borderline Product Classification Applications as at 09.12.2025

December 11, 2025

Reference values for “Collagen” to be considered under “Borderline Product” Category

December 10, 2025

Important Links

Regulatory Updates

Reference values for “Collagen” to be considered under “Borderline Product” Category

December 10, 2025
  • The safe and effective amount of “Collagen” - 2.5 to 15 grams of hydrolyzed collagen peptides.
  • The final decision (on collagen containing products) will be the committee decision.

Regulatory Updates

Rejected Borderline Product Classification Applications as at 09.12.2025

December 11, 2025

This web notice is published to avoid inconvenience during custom importation, in accordance with the web notice issued on 5th March 2025. Relevant
classification reports will be issued as early as possible. (This publication has initiated from 86th Subcommittee of BPEC)

Click Here : Rejected Borderline Product Classification Applications

Regulatory Updates

Reference values for “Collagen” to be considered under “Borderline Product” Category

December 10, 2025
  • The safe and effective amount of “Collagen” - 2.5 to 15 grams of hydrolyzed collagen peptides.
  • The final decision (on collagen containing products) will be the committee decision.

Regulatory Updates

Olopatadine Hydrochloride Ophthalmic Solution 0.2% w/v

December 12, 2025

New applications are not accepted and renewal of existing applications will not be continued for the 0.2% w/v strength of Olopatadine Hydrochloride Ophthalmic Solution under "Need" clause

Regulatory Updates

Notice regarding transport license applications.

December 12, 2025

Effective December 15, 2025, all applicants for new transport licenses and for the renewal of existing transport licenses are required to use the new application
format and submit all necessary documentation strictly according to the newly published checklists.

Regulatory Updates

Mandatory Trilingual Labeling on Dispensing Envelopes and Containers

December 11, 2025

According to the recommendations of the National Language Commission, all information and instructions displayed on dispensing envelopes and containers for medicines must be provided in Sinhala, Tamil, and English, in compliance with the National Language Policy.

Click Here: