Sri Lanka Updates Borderline Product Regulations and Application Requirements

On March 5, 2025, Sri Lanka’s National Medicines Regulatory Authority (NMRA) issued an announcement introducing new requirements for borderline products, covering registration, customs clearance, ingredient guidelines, and labeling.

Key updates include:

• Mandatory ASYCUDA System for Customs Clearance: Under the new framework, borderline products will only be cleared through Sri Lanka Customs' ASYCUDA system if they have been registered. To facilitate the transition, NMRA has granted a grace period for classification application submission until April 30, 2025. If enterprises meet this deadline, they can release their products without full registration until October 31, 2025. However, starting May 1, 2025, only fully registered products will be eligible for clearance through the system.

• New Ingredient Guidelines: A new guideline defining Tolerable Upper Levels (TUL) and regulatory limits for specific ingredients—including Fluoride, Probiotics, Co-enzyme Q10, and Omega 3—will be introduced. Once published, compliance with these guidelines will become mandatory.

• Mandatory Labeling Requirements: From August 31, 2025, all registered borderline products must display a model label on their commercial packaging.

Model Label (Source: NMRA)To strengthen regulatory oversight, on March 25, 2025, the NMRA issued another announcement detailing application procedures for borderline products, including classification requests, Sample Import Licenses (for imported products), Formulation Approvals (for locally manufactured products), and registration dossier submissions.

• A Classification Report will be valid for one year, with only two additional data submissions allowed per application.

• Applications for Sample Import Licenses and Formulation Approvals must be submitted within one year of receiving Classification Report approval, and these approvals will also be valid for one year.

• Registration dossiers must be submitted within the validity period of the Sample Import License or Formulation Approval.

• Failure to meet these deadlines will result in consignment clearance rejection.

ChemLinked Comments

In Sri Lanka, borderline products refer to items with combined characteristics of medicines along with foods, medical devices, or cosmetics. All such products must be registered with the NMRA through a three-step process:

1. Preliminary evaluation (product classification)

2. Formulation approval (required only for local manufacturers) or sample import license (required only for foreign manufacturers)

3. Product registration

Process of Registration (Source: NMRA)

These regulatory updates reflect NMRA’s intent to tighten control over borderline products while ensuring a smoother transition for businesses. Stakeholders are advised to adhere to the revised deadlines and documentation requirements to prevent clearance disruptions.