National Medicines Regulatory Authority

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This guideline intends to provide home delivery of therapeutic goods is permitted solely as a value-added service by licensed retail pharmacies. Such services are intended to enhance patient access to therapeutic goods. It is imperative that therapeutic goods are delivered to patients' homes in a manner that safeguards their well-being, ensures the quality and integrity of the therapeutic goods, and minimizes risks. This guideline outlines the key requirements for ensuring the proper handling, packaging, and delivery of therapeutic goods, as well as measures to uphold patient safety during the process.

NMRA welcomes your comments & feedback on the Draft guideline for the establishment of home delivery service for supply of therapeutic goods by licensed retail pharmacies

This will be started from 07th of March 2025 to 17th of March 2025.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to pa20@nmra.gov.lk & aa18@nmra.gov.lk by 17th of March 2025

Current issues related to the products coming under the category of borderline products;

A. Classification application submission and customs release for the products which may come under the borderline product category

As per the NMRA Act, since 2016, the Borderline Product Regulatory Division has being continuously involved in the product registration. Majority of importers have brought such products to the country without obtaining the product registration from NMRA and recently Sri Lanka Customs introduced an online platform called as ASYCUDA SYSTEM to release the products linking with other relevant government regulatory bodies.

Once introducing this ASYCUDA SYSTEM, many importers were unable to release their products through the system due to unavailability of product registration. As a result of, it creates a gap between a regulatory perspectives and continuation of market field causing an accumulation of goods at Sri Lanka Customs.

For this matter following solutions were proposed:

1. Products release through the ASYCUDA SYSTEM only;

Products that fall under the borderline category will be released only through the ASYCUDA system, and registration is a mandatory requirement. However, a deadline was proposed for the classification applications submission: April 30, 2025 to release the product through the ASYCUDA system without the product registration (Classification application submission is mandatory ) and the consignments could be released until 31, October 2025

2. Normal registration approval process will be effective for the applications submitted from May 1, 2025, and product release will be conducted through the ASYCUDA system only for the registered products.

3. Anyhow during the registration process (including the classification step) if any product is rejected, the consignment clearance will be discontinued (for 1 & 2).

4.For consideration of custom clearance of a product, it is mandatory to upload the acknowledgment form/s of application submission (Classification, Sample Import license and Registration Dossier) 3. Offence against the misleading/incorrect information found in a product:

5.Offence against the misleading/incorrect products;

Any misleading/incorrect information (related to a product) in an advertisement, on the label, PIL, packaging materials or in any other manner will be punishable offence under the requirements of the NMRA Act, No. 5 of 2015.

B. Publication of new guideline related in borderline products

A guideline will be published in due course for the following list of products, including TUL(Tolerable Upper Levels), Minimum, and Maximum levels. Once the guideline is published, adherence to the guideline will be required for the continuation of product registration

List of ingredients :Fluoride, Probiotics, Chondroitin, D-Mannose, Alpha-lipoic acid (ALA),Choline, Glucosamine, Co-enzyme Q10, Inositol, Omega 3 (EPA +DHA), Omega 6 (gamma Linoleic acid), Taurine, N-Acetyl cysteine, Methyl Sulphonyl Methane (MSM), N-Acetyl L-tyrosine, Vitamin K2, Phosphatidycholine (Lecithin), Carnitine and Boron

C. Export only products;

Export only products will not be considered for product registration under the category of borderline products.

Exceptions: product registration in reference NRAs

D. Model label for registered borderline products

A sticker or label on the commercial pack will be mandatory for all registered borderline products, with effective from August 31, 2025.

Model label:

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Notice to all Authorized Local Agents

Subject : Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of March 2025, the United States Dollar (USD) rate is considered as 297.27 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

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