Borderline product regulatory affairs
Borderline product classification and registration in Sri Lanka
Some products have features associated with medicines, foods, cosmetics or medical devices, making their regulatory category less obvious.
RAQ Consultation helps clients review intended use, ingredients, concentrations, claims and product documents before preparing for the applicable National Medicines Regulatory Authority (NMRA) classification and registration requirements.
Why classification matters
The product determines the category, not the name on the box
The NMRA's borderline-product assessment considers matters such as the product's intended use and mode of action, its claims, and the active substances it contains and their concentrations. A product described commercially as a supplement, herbal product or personal-care item is not automatically assigned to a particular regulatory category.
A preliminary review can identify the questions and evidence that should be presented, but the formal classification decision belongs to the NMRA.
More detail: the NMRA's published evaluation criteria
The NMRA describes borderline products as products with combined characteristics of medicines along with foods, medical devices or cosmetics. It regulates them under the National Medicines Regulatory Authority Act No. 5 of 2015, and its Borderline Products Evaluation Committee carries out the technical evaluation. The NMRA's published criteria are:
Intended use and mode of action
What the product is for, its primary function and how it works.
Therapeutic claims
Whether the product is claimed to treat or prevent disease.
Pharmacologically active substances
Whether the product contains any, and which.
Concentration of active substances
How much of each active substance the product contains.
Level of efficacy
The efficacy of the active substances in the product.
Ingredients and concentrations
All ingredients used and the amounts at which they are used.
More detail: why a name or dosage form is not enough
Nor does the fact that a product contains vitamins, minerals or plant extracts, or comes as a capsule, tablet or powder, decide its category on its own. Some such products are classified as borderline products; others are not. The NMRA looks at the product as a whole. The label, packaging artwork, product leaflet and any promotional material are submitted with the classification application, so the way a product is presented and the claims made for it form part of the file the NMRA evaluates.
How RAQ assists
Get the classification questions answered first
- 01
Preliminary assessment
Review the product and flag classification issues that may affect the pathway.
- 02
Classification document support
Organise the data and declarations required for the applicable NMRA assessment.
- 03
Local formulation documentation
Assist with relevant formulation-approval material and the current submission requirements.
- 04
Imported-product dossier review
Assess supporting documents and local-authorisation information for the applicable route.
- 05
Registration coordination
Support document preparation and regulatory follow-up within the agreed engagement.
The NMRA decides classification and registration. RAQ cannot guarantee approval or an approval date.
The NMRA route
Classification and the next regulatory steps
Steps 2 and 3 are alternatives: the first applies to locally manufactured products, the second to imported products.
NMRA route · summary
- Preliminary evaluation and classification: the responsible applicant provides the product information needed for the NMRA to assess whether it falls within the borderline-product category. The NMRA issues the classification report under the relevant process.
- Local formulation requirements: locally manufactured borderline products need formulation approval, which the NMRA lists as the step for local manufacturers. Under the NMRA's current specific notice for new local applications, the formulation-approval documents, other than the classification report, are submitted together with the classification application, with the applicable formulation-approval fee at that stage.
- Imported-product requirements: for imported borderline products, the applicable process includes classification, Sample Import Licence requirements and registration documentation as set out by the NMRA.
- Product registration: a classification decision is not the same as product registration. The applicant must meet the applicable product-registration requirements and any manufacturing, labelling or safety obligations.
More detail: the full sequence, including the applicant profile
- Preliminary assessment (optional, by RAQ): before applying, RAQ can review the intended use, claims, dose and composition and give a view on the likely category questions. This is RAQ's opinion only; it is not a classification.
- Profile: the NMRA requires a local agent or local manufacturer profile before classification. When checked on 25 October 2026, the NMRA's page stated that online profile creation was temporarily on hold because of a system failure and that submissions were manual.
- Classification application: the product file is submitted to the NMRA's Borderline Products Regulatory Division.
- NMRA classification report: the NMRA's classification decision. A report may be issued as awaiting additional data, in which case further information is requested.
- Sample Import Licence (imported) or formulation approval (local).
- Registration: the registration dossier is evaluated. The registration period is stated on the registration certificate.
More detail: after registration
Model label
Since 31 August 2025, a sticker or label following the NMRA's model is mandatory on the commercial pack of every registered borderline product.
Customs release
The NMRA states that borderline products are released only through the ASYCUDA system, that the normal registration procedure applies to submissions from 1 May 2025, and that rejection at any stage discontinues consignment clearance.
Import and manufacturing data
Applicable importers and local manufacturers must submit import or manufacturing data in the format prescribed by the NMRA, including the relevant quarterly reporting periods.
Changes and advertising
Changes to a registered product use the NMRA's variation application (F-BPR-008). Advertising requires prior written NMRA approval.
The NMRA's registration requirements refer to the previous registration certificate for re-registration. When checked on 25 October 2026, the borderline page did not describe a separate renewal procedure, so RAQ confirms the current requirements with the NMRA well before a registration expires.
The NMRA published a general notice on amendments to registration certificates and licences on 2 September 2026. How it applies to borderline products is confirmed with the NMRA for each case.
Local and imported projects
Three circumstances that should not be confused
Local · new applications
New locally manufactured applications
The current local notice brings classification and formulation-document submission together for new applications. It does not mean that classification and formulation approval are automatically granted together.
Local · transitional
Previously submitted local classification applications
Where the classification application had already been filed before the new notice applied, the NMRA's transitional instruction directs the applicant to submit the formulation-approval application separately, with the classification report, under the earlier procedure.
Imported
Imported borderline products
Imported products are assessed using the relevant foreign-product documentation, local authorisation and subsequent Sample Import Licence and registration requirements. The NMRA requires foreign manufacturers to apply through a Marketing Authorization Holder (local agent) in Sri Lanka.
More detail: imported products, the Marketing Authorization Holder and free sale certificates
Three applications
- Classification (preliminary evaluation): the NMRA issues a classification report.
- Sample Import Licence: applied for with the classification report. It is a licence to import a limited quantity of the product for the purposes the NMRA lists, such as testing, examination and sample analysis.
- Product registration: the registration dossier is evaluated.
Marketing Authorization Holder
The Marketing Authorization Holder (local agent) is responsible for registration, licensing, importation, sale and distribution, and handling of quality failures. The manufacturer's Letter of Authorization is addressed to the NMRA's Director General / CEO.
RAQ Consultation supports international manufacturers with Sri Lankan regulatory requirements, documentation, NMRA applications and coordination with appropriately authorised local agents; see MAH and local regulatory support. Formal representation arrangements are assessed separately according to applicable regulatory requirements. The MAH's legal responsibilities rest with the appointed MAH.
Foreign manufacturing sites
Foreign manufacturing sites need NMRA approval, with a separate application for each site. The NMRA describes a desk review that includes the site master file; a GMP inspection may be required, and the NMRA states that it would exempt the onsite inspection if the site had been inspected by a stringent regulatory authority or the WHO.
| Issued by | NMRA position (summary) |
|---|---|
| Government food and drug authority, or recognised government food regulator | Accepted |
| Another government body | Must clearly state that the product is freely sold in the country of origin, with verifiable documents such as GMP certificates |
| Ministry of Commerce or Industry | GMP certificate and manufacturing licence with the product list also required |
| Chamber of Commerce | Acceptable only for cosmetic-related borderline products |
A valid Certificate of Pharmaceutical Product addressed to Sri Lanka may be used instead. It must state that the product is licensed in the country of origin, include its explanatory notes and be signed by a designated person. The NMRA's checklists (F-BPR-009 and F-BPR-010) state that, where a certificate gives no validity period, its issue date should not be more than two years before submission.
More detail: local manufacturing sites
The NMRA describes licensing of local manufacturing sites through a desk review of the site master file and GMP inspections, followed by formulation approval, product registration and product manufacturing licences. It lists a separate GMP certificate application as optional for local manufacturers. RAQ's quality and GMP consulting can help a manufacturer prepare.
The registration dossier includes manufacturing-site evidence and a valid manufacturing licence with the product list. The NMRA's overview lists an ISO certificate where a GMP certificate is not available, while its registration checklist refers to GMP evidence. RAQ confirms with the NMRA which site evidence is accepted for each product and site.
Local manufacturing
Manufacturing-site and GMP requirements for locally manufactured borderline products
Manufacturers producing borderline products in Sri Lanka must comply with the applicable NMRA manufacturing-site approval and Good Manufacturing Practice (GMP) requirements.
The manufacturing-site process may involve facility assessment, review of the Site Master File and supporting quality documentation, and NMRA GMP inspections or audits where required.
For product registration, applicants must provide the relevant manufacturing-site documentation, GMP evidence, manufacturing licence and other supporting records required under the applicable NMRA procedure. The NMRA's Borderline Products page lists a GMP report or GMP certificate for the manufacturing site, an ISO certificate if a GMP certificate is not available, and a valid manufacturing licence with the product list.
An alternative document is not an exemption
An alternative document mentioned in NMRA guidance, such as an ISO certificate where a GMP certificate is not available, should not be treated as an automatic exemption from manufacturing-site approval or GMP obligations. The NMRA does not state which ISO standard or issuing body it accepts for this purpose, so its applicability must be established for the particular product and manufacturing arrangement.
Manufacturing-site approval is separate from product classification, formulation approval and individual product registration. Imported products provide GMP evidence for the overseas manufacturing site with their own registration documents; the local site-approval process described here applies to manufacturing in Sri Lanka.
RAQ Consultation assists local borderline-product manufacturers with facility documentation, Site Master Files, GMP gap assessments, SOP development, inspection preparation and regulatory coordination. See Quality systems and GMP consulting.
Formulation, ingredients and claims
What we look at during document review
Product composition
Ingredient identities, quantities, unit-dose and batch formula information, and relevant specifications must be sufficiently clear for the applicable evaluation.
Intended use and claims
Claims on labels, inserts, advertisements and other materials should reflect the product's regulatory category and available evidence.
Market documentation
The source and content of Free Sale Certificates, Certificates of Pharmaceutical Product, manufacturer authorisations and quality documents may matter, depending on the product and stage.
Warnings and schedules
The NMRA has category-specific scheduling and labelling requirements. The applicable schedule should be confirmed rather than assumed from the product name or format.
More detail: formula and ingredient requirements
The NMRA requires the unit-dose composition (master formula) with the batch manufacturing formula. If overages are added, their quantities and percentages must be stated; raw-material specifications are given, and active ingredients are distinguished from excipients. Vitamins and minerals are expressed in the forms and units of the NMRA's reference guideline: for example sodium as Na, not as sodium chloride. The NMRA states that non-compliant applications are rejected.
The NMRA publishes reference guidance used in its evaluation, including for vitamins and elements, additional active ingredients, amino acids, iodine and collagen. It states that its committee makes the final decision (for example on collagen products). These references are not a self-assessment tool. The NMRA has also listed ingredients, including fluoride, probiotics and glucosamine, for which a further guideline is awaited, and states that once it is published, adherence will be required for products to remain registered.
More detail: claims
Health-benefit claims must be supported by data submitted for evaluation. Misleading or incorrect information on a label, leaflet, pack or advertisement is an offence under the NMRA Act. RAQ recommends reviewing claims, dose and composition together before a classification application, because each can affect the outcome.
More detail: schedules and special cases
Risk schedules
The NMRA classifies borderline products into three risk-based schedules (Schedule I, IIA and IIB) and publishes lists of registered products by schedule. The documents required for a particular schedule are confirmed with the NMRA for each product.
Schedule IIB special category
An NMRA notice of 1 July 2026, addressed to Marketing Authorization Holders, requires "Prescription Only" on the label and leaflet for this category, among other leaflet requirements. Its exact scope is confirmed with the NMRA for each product.
Export-only products
The NMRA states that export-only products are not considered for registration as borderline products, except in connection with registration by reference regulatory authorities.
Typical documentation areas
Documents often needed for initial review
- Product name, dosage form and intended use.
- Manufacturer, manufacturing-site and local applicant information.
- Letter of Authorization where applicable.
- Quantitative master and batch formula information.
- Label artwork, directions and patient or consumer information.
- Applicable analysis and quality documents.
- Free Sale Certificate or other acceptable foreign regulatory documentation for imported products, where required.
- Existing NMRA reports, correspondence or application references, if any.
The NMRA publishes a one-year validity for the classification report. Its separate submission instructions also set deadlines for requesting the relevant Sample Import Licence or formulation approval and for filing registration while that licence or approval remains valid. The sequence and dates should be confirmed for the individual application.
Time limits published by the NMRA
- 1 year
- Classification report validity, counted from its approval date. The NMRA states that the registration process should be started within this period.
- 3 months
- For each additional-data submission, counted from the classification report that requested it. No more than two additional-data submissions are allowed per classification application.
- 1 year
- The Sample Import Licence or formulation approval application is made within one year of classification approval, and that licence or approval is valid for one year.
- Within validity
- The registration dossier is submitted while the Sample Import Licence or formulation approval is valid.
The NMRA states that failing to submit within these periods may lead to rejection of consignment clearance approval. These are deadlines for applicants, not NMRA decision times. The NMRA has not published separate time limits for the combined local submission introduced in July 2026; RAQ confirms the current position for each application.
Detailed document checklist: classification application
- Covering letter
- Manufacturer's Letter of Authorization addressed to the Director General / CEO of the NMRA (imported products)
- Master formula and batch manufacturing formula
- Free sale certificate or Certificate of Pharmaceutical Product (imported products)
- Declaration
- Finished-product certificate of analysis
- Label and packaging artwork, product information leaflet and any promotional material
Detailed document checklist: formulation approval (local manufacturers)
- Classification report (not required for new combined submissions)
- Covering letter with contact details (email, telephone numbers and addresses)
- Formulation: master formula and batch manufacturing formula
- Legible product information leaflet or pack insert
- Legible specimen coloured label and packaging materials (artwork acceptable)
Detailed document checklist: Sample Import Licence (imported products)
- Classification report issued by the NMRA
- Application for a licence to import a limited quantity of borderline products
- Copy of the business registration certificate
- Copy of the manufacturer's Letter of Authorization addressed to the Director General / CEO of the NMRA
- Catalogue, if applicable
- Valid free sale certificate or Certificate of Pharmaceutical Product
- Specimen coloured label and packaging materials
Detailed document checklist: registration dossier
- Classification report, and the Sample Import Licence (imported) or formulation approval (local)
- Manufacturing-site GMP evidence and manufacturing licence with the product list
- Finished-product specifications and certificate of analysis; certificates of analysis and the GMP certificate for active ingredients
- Master and batch formula, manufacturing process and flow diagram
- Stability data or a shelf-life declaration, as the product's schedule requires
- Product leaflet, labels, maximum retail price and samples
- The NMRA's acknowledgment form (F-BPR-011)
- Imported: manufacturer's Letter of Authorization and free sale certificate or Certificate of Pharmaceutical Product
Common documentation problems we help identify
- Formulas that give salts instead of elemental amounts, omit overages or do not match the label.
- Claims on the label or in promotional material that go beyond the evidence or affect the classification.
- Free sale certificates from issuers the NMRA accepts only with extra documents, or not at all for the product type.
- A classification report, licence or approval that expires before the next application is submitted.
- Additional-data requests answered late or incompletely, using up the two permitted submissions.
- Missing stability data or shelf-life declarations where the product's schedule requires them.
FAQs
Frequently asked questions
Is a food supplement always a borderline product?
No. Classification depends on the product's characteristics and the NMRA's assessment. The commercial term used for a product does not by itself determine its regulatory category.
Does an ISO certificate exempt a local manufacturer from NMRA GMP requirements?
No. The NMRA's Borderline Products page mentions an ISO certificate only where a GMP certificate is not available. That does not remove the manufacturing-site approval and GMP obligations, and its acceptance must be established for the particular product and site. See local manufacturing sites and GMP.
Can RAQ issue a classification report?
No. RAQ can assist with preliminary review and application preparation, but the NMRA makes formal classification decisions.
Does the new local submission process remove formulation approval?
No. The notice changes when the relevant documents and fee are submitted for new local applications. It does not remove the requirement for the NMRA's substantive evaluation or decision.
Is imported-product registration the same as local formulation approval?
No. The applicable procedures differ between imported products and locally manufactured products.
Can we import products while classification is pending?
Importation and customs clearance depend on the current requirements and the product's regulatory status. Do not assume a pending application authorises commercial importation.
Is a product registered abroad automatically accepted?
No. Foreign registrations and certificates can support the file, but the NMRA classifies and evaluates each product under its own requirements.
How long does registration take?
It depends on the product, the completeness of the file and any additional-data requests. The NMRA publishes time limits for applicants, not decision dates. RAQ does not guarantee approval or an approval date.
Official NMRA references
- NMRA: Manufacturing sites (opens in a new tab) ↗
- NMRA: Borderline Products (process, forms, guidelines, schedules) (opens in a new tab) ↗
- NMRA: Notice to local manufacturers of borderline products (1 July 2026) (opens in a new tab) ↗
- NMRA: Details related to borderline applications (opens in a new tab) ↗
- NMRA: Schedule IIB special category criteria (1 July 2026) (opens in a new tab) ↗
- NMRA: Guidelines (opens in a new tab) ↗
- NMRA: Announcements (opens in a new tab) ↗
Contact RAQ
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