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“Borderline products” are products having combined characteristics of medicines along with foods, medical devices or cosmetics. The following criteria shall be taken into consideration when evaluating borderline products for registration:

• The intended use of the product (or its primary function) and its mode of action
• The therapeutic claims made by the manufacturer regarding the product in terms of its ability to treat or prevent diseases
• Pharmacologically active substance(s), if any, used in the product.
• The concentration of the active substances
• The level of efficacy of the active substance of the product
• The ingredients used and the concentrations at which they are used.

According to the National Medicines Regulatory Authority Act No. 05 of 2015 the National Medicines Regulatory Authority shall be responsible for the regulation and control of registration, licensing, manufacturing, importation and all other aspects pertaining to borderline products; The Borderline Products Evaluation Committee (BPEC) will carry out the technical evaluation of products submitted for registration and assist the Authority to regulate and control all aspects pertaining to borderline products.

Scope and Responsibilities of the NMRA in the approval of borderline products
The National Medicines Regulatory Authority (NMRA) is responsible to build a healthier nation by ensuring the availability of quality and safe borderline products in Sri Lanka. As such all products which may come under Borderline Product category should be registered with the Authority.
All foreign borderline products manufactures should submit application for registration through a Marketing Authorization Holder (local agent) in Sri Lanka who shall be responsible for the registration, licensing, importation, sale and distribution, handing of quality failures and all aspects pertaining to the particular borderline product in Sri Lanka.

Scheduling criteria of Borderline products depending on the level of risk

Borderline products have been classified to three schedules by the BPR division in the registration process depending on the level of risk and to make sure the awareness of the general public regarding the level of risk of such products.

Schedule I

(General sales products)

Schedule IIA

Schedule IIB

Not necessary retail sales license

Sold only in pharmacy

Sold only in pharmacy

Prescription is not necessary

Prescription is not necessary

Prescription is necessary

Minimum risk

Low risk

Risk is high


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