To: All applicants who submit samples for analysis for registration purposes.

The test methods followed by NMQAL are mostly Pharmacopoeia methods. Almost all pharmacopoeia monographs need Reference Standards and those standards should be obtained from the sources recommended in the test monograph. These sources are mainly United States Pharmacopoeia (USP), British Pharmacopoeia (BP), Indian Pharmacopoeia (IP), European Pharmacopoeia etc.

In most cases the laboratory is unable to issue quality reports of the samples received due to lack of Reference Standards. To overcome this difficulty the Authority Board granted approval to request the applicants to submit the Reference materials for pre marketing testing and deduct the cost for the Reference material from the total fee of the laboratory tests.

Hence, applicants are requested to submit the Reference Standard with the sample if the specification of the sample is one of the above pharmacopoeia.

NMQAL will deduct the cost of the Reference material which is indicated in the relevant latest standard catalogue published by the source (USP, BP, IP etc).

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Note: If the cost of the standards has been given in any other currency in the catalogue, foreign currency rates are converted at the selling rate on last working day of the preceding month which was published by the Central Bank of Sri Lanka and total payable amount is calculated as above accordingly.

If the test method is non pharmacopoeia (i.e. Manufacturer’s in house method) required Reference Standards (with relevant qualification data) must be provided by the applicant free of charge at the time of samples submitted to NMQAL for testing.

This procedure is effective from 06th June 2022.

(Date: 31 May 2022)