The National Medicines Regulatory Authority (NMRA) of Sri Lanka, established in 2015, is an independent authority in the Ministry of Health that ensures that medicinal products meet safety, quality, and efficacy standards. It regulates medicines, medical devices, borderline products, clinical trials, and cosmetics.

The NMRA is governed by a board that provides strategic leadership and advises on the authority’s functioning. The National Medicines Regulatory Authority’s Board regulates labeling requirements for healthcare products to strengthen safeguards against falsified products entering the market.

The draft “Notice,” published on 15.07.2024 and amended on 13.08.2024, envisions two changes to the labelling requirements.

As per the notification, QR codes or 2D barcodes on the product’s labelling, which are intended for logistics control, are allowed. However, indication of website addresses is not allowed.

1. Product-specific QR or bar code of the manufacturer encoding the following information (application three months after the first of September 2024):

• The product name
• The generic name and strength
• Batch number
• Date of manufacturer
• Date of expiry
• Name of the manufacturer and site address

2. Stickers to be placed on each commercial pack indicating the wording “NMRA approved” and the retail price (applicable from the first of October 2024)

The label is recommended to be implemented for all batches released to the market with effect from 1^st November 2024.

The container of every medicine classified under Schedules II and III of the NMRA regulations shall be accompanied by a printed insert containing information drawn up in accordance with the summary of product characteristics.

Every medicine specified in Schedule I or Group A of Schedule II of the NMRA regulations shall be accompanied by a patient information leaflet (a leaflet accompanied with the medicinal product containing specific information in lay language for the patient).

If the product is sold without a separate leaflet, the information that is required in the PIL must be stated on the outer carton or the primary label.

Purpose of the NMRA guidelines:

• Product Identification for product suppliers in the market
• Avoid medication errors
• Achieve proper handling & storage of the product
• Traceability of the product in case of quality concerns

On draft notification – final authoritative instruction is under discussion with pharmaceutical stakeholders, post which final notification will be released as compliance guidelines.

NHMA expects the fullest corporation to implement these controls and help prevent falsified products from entering the market.

Resource – https://www.nmra.gov.lk/pages/guidelines