National Medicines Regulatory Authority

This is a reminder regarding the earlier notice issued on 5th of March 2025, concerning the labeling requirement for registered borderline products.

As stated in the earlier notice, it will be mandatory for all registered borderline products to carry a sticker or label on the commercial pack, effective from 31st of August 2025.We kindly urge all relevant stakeholders to ensure full compliance with this requirement by the stated deadline.

Model label:

All local manufacturers are hereby requested to submit data related to second brand/generic applications for pharmaceutical products that are already registered with the National Medicines Regulatory Authority.

This information is being collected to support regulatory evaluation and database updates.

Kindly fill in the Google Form using the link below and attached the mandatory documents listed.

Click here to access the Google Form :

https://forms.gle/4t9PJwBErcN2ZgPY9

Mandatory Documents (to be uploaded for each product and each strength):

1.   Copy of the previous Registration Certificate

2.  Copy of the last Evaluation Report

3.  Duly filled Declaration Format declaring the sameness of the product (separate declaration required for each product an each strength)

Instructions:

• Submit separate entries for product/strength.
• Ensure that all attached documents are clear, complete and legible.

Your timely cooperation in this matter is highly appreciated.

This web notice is published to avoid inconvenience during customs 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 been initiated from 80th Subcommittee of BPEC)

Click Here: Rejected Borderline Classification Applications

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All Market Authorization Holders of medicines are hereby informed that, with effect from 01^stAugust 2025 applications for the renewal and re-registration will not be considered for registration unless the following documentation is submitted at the time of application submission, in accordance with the provisions of Section 65(d) of the National Medicines Regulatory Authority Act, No.5 of 2015.

1.    Imported Medicines:

Application must be included;

•   Evidence of Importation during the past two (02) years,

•   Proof of participation in tenders, or

•   A written clarification for the absence of importation or non-participation in tenders during the specific period.

2.    Locally Manufactured Medicines:

Application must be included;

·     Evidence of production within the past two (02) years,

·     Proof of participation in tenders,or

·     A written explanation if the product has not been manufactured or has not participated in tenders during the specific period.

Important:

Applications submitted without the above mandatory information will not be accepted for evaluation. This requirement is enforced under the authority of Section 65(d) of the NMRA Act, which empowers the Authority to ensure the continuous availability of registered medicinal products in the market.

Additionally, for applications already submitted without the required documentation, evaluators are instructed to request the necessary information via email prior to granting registration.

Your strict compliance with this directive is expected.

This is to inform all Marketing Authorization Holders and Importers of Medicines that the National Medicines Regulatory Authority (NMRA) will restart the procedure of including the Maximum Retail Price (MRP) on import licenses and the submission of pricing information for import license renewals. This procedure is in line with the provisions of the NMRA Act and relevant regulations.

Accordingly, the approved MRP will be included in import licenses at the time of renewal for all import licenses expiring on or after 1st of November 2025. Therefore, all import license renewal applications for licenses expiring on or after 1st of November 2025 must be submitted ten (10)weeks prior to the license expiry date.

Applicants are required to commence document submission immediately, from today on wards, to ensure timely processing of renewal applications for licenses expiring on or after 1st of November 2025.

In addition, the NMRA Pricing Division will send an email request for price details as part of this process. Marketing Authorization Holders and importers are requested to respond and submit the price details in the standard pricing format within two weeks to ensure timely processing.

Failure to comply with the specified timeline may result in delays in license renewal and potential disruption to product availability.

We urge all import license holders to strictly adhere to the above requirements and ensure the timely submission of all necessary documentation.

CEO
National Medicines Regulatory Authority(NMRA)

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