Borderline Products
Navigating Borderline Product Registration in Sri Lanka
Expert classification and registration support for products that fall betweenmedicines, foods, cosmetics, and medical devices.
What is a Borderline Product?
Defining the Grey Area
“Borderline products” are among the most complex to register, as they have combined characteristics of different product categories. The NMRA defines them as:
“Products having combined characteristics of medicines along with foods, medical devices or cosmetics.“
Correct classification is the critical first step. The NMRA evaluates these products based on several key criteria to determine their primary function and appropriate regulatory path:
- Intended Use: The product’s primary function and its mode of action.
- Therapeutic Claims: Any claims made by the manufacturer about treating or
preventing disease. - Active Substances: The presence and concentration of any pharmacologically active ingredients.
- Efficacy and Ingredients: The proven effectiveness and the specific formulation of the product.
At RAQ, our primary goal is to help you achieve the correct classification for your product, setting the foundation for a successful registration.
The NMRA Schedule System
Understanding Your Product's Market Placement
Once classified, the NMRA assigns borderline products to one of three schedules, which determines how they can be sold in Sri Lanka. This classification is based on the product’s risk profile.
| Schedule | Sales Requirement | Prescription | Risk Level |
|---|---|---|---|
| Schedule I (General Sales Products) | Retail sales license not necessary | Prescription not necessary | Minimum Risk |
| Schedule IIA | Sold only in pharmacy | Prescription not necessary | Low Risk |
| Schedule IIB | Sold only in pharmacy | Prescription is necessary | High Risk |
Our End-to-End Registration Services
A Strategic Approach to a Complex Process
Product Classification Support
This is the most crucial phase. We compile and submit the complete Classification Dossier to the NMRA to get an official determination of your product’s category and schedule.
Full Registration Dossier Preparation
Once classification is confirmed, we prepare and submit the full Registration Dossier, ensuring all administrative and quality documents meet the specific requirements for your product’s assigned schedule.
Dossier & Document Review
We meticulously review all your documentation, from the Product Master Formula and Free Sale Certificate (FSC) to stability data and GMP certificates, ensuring everything is compliant before submission.
Professional NMRA Liaison
We act as your professional point of contact with the NMRA, managing both the classification and registration submissions and handling all regulatory queries to
ensure a smooth review.
The RAQ Advantage
Why Partner with RAQ for Borderline Products?
At RAQ by Healin’ Pvt Ltd, we understand the intricacies of borderline product registration.
Expertise in Classification
The success of a borderline product registration hinges on the initial classification. Our deep understanding of the NMRA's evaluation criteria gives your product the best chance of being classified correctly from the start.
Strategic & Meticulous
We understand the nuances between schedules and the specific documentation required for each. Our attention to detail prevents common errors that can lead to delays or incorrect classification.
A Clear Path Forward
The ambiguity of borderline products can be a significant business challenge. We provide a clear, strategic path through the regulatory process, allowing you to plan your market entry with confidence.
Call to Action
Clarify Your Product's Path to the Sri Lankan Market
Don’t let regulatory ambiguity hold you back. Contact us today for an expert consultation on your borderline product.