All marketing authorization holders of medicine are hereby informed that NMRA decieded to revoke the decision taken to register only Extended Release Donepazil Hydrochloride Tablets based on the recommendation given by 77th Medicines Evaluation Committee held on 25th April 2023
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All marketing authorization holders of medicine are hereby informed that NMRA decided to re-register multivitamin products which were registered as medicines under the CDDA Act can be continued under medicines based on the recommendation given by the 76th Medicines Evaluation Committee held on 28th March 2023
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All local manufactuerers and marketing authorization holders are hereby informed that dossier accepting point of Medicines Regulatory Division will be opened on 04th of May (Thursday) 2023 from 9.00 a.m to 3.15 p.m.
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To all MAH of Medicines
This is to inform you that the Board of NMRA has approved to expedite evaluation of new dossiers and their additional data which are submitted due to manufacturing site change. The brand of such product should be registered more than five years or more in Sri Lank from previous site.
If you have submitted new applications due to manufacturing site change, please send the list of details as per the following format to This email address is being protected from spambots. You need JavaScript enabled to view it. to expedite evaluation process.
| Name of Local Agent | ||||
| Dossier Number | Name of the product | Brand Name | Name and address of the previous manufacturer | Name and addresss of the new manufacturer |
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All Marketing authorization holders of medicine are hereby informed that 72nd Medicines Evaluation Committee held on 22nd November 2022 recommended not to register new products of Ketorolac Tromethamine Orally Disinegrating Tablets and not to renew or issue import license for existing Ketorolac Tromethamine Orally Disinegrating Tablets.
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