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All topical and oral Glutathione containing products should be registered under the Borderline Products Regulatory Division/NMRA.
Intravenous (IV) products are not registered under the Borderline Products Regulatory Division and intravenous Gluathione containing products are not recommended as skin lightening agents. (31st BPEC-2021/02/16)
NMRA prior approval should be obtained for advertisement purpose of all such products.
Therefore, you are requested to initiate the product registration and follow the below instructions.
2. Submission for product classification
3. Obtained the Sample Import Licenses
4. Submit the registration dossier
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The following conditions should be strictly followed by the pharmacist/s and staff during opening hours.
- Maintain the minimum distance of 1 m between each customer and dispensing pharmacist to ensure social distancing.
- Hand sanitizing facility should be available at the entrance to the pharmacy and customers should disinfect hands thoroughly before entering the pharmacy.
- A notice should be displayed on the main door stating: -Opening hours of the pharmacy. - Requirement of a valid prescription or a clinical record with the customer for purchasing prescription medicines.
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Extension of validity period of registration certificate and licenses of Medicines, Medical Devices, Borderline products and Cosmetic Products and licenses of retail pharmacy, Wholesale and transport for therapeutic goods.
I. Extension of the validity period of registration certificate and licenses.
It is hereby noticed that, considering the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to extend the validity period of certificates of registration and import licenses pertaining to Medicines, Medical Devices, Borderline Products and Cosmetics and licenses pertaining to retail pharmacy, Wholesale and transport for therapeutic goods up to 31st December 2020. The extension is applicable for certificates and licenses expiring after 30th of June 2019.
Restriction for issuing Waiver of Registration (WORs) with effect from 26th of June 2020
With reference to the National Medicines Regulatory Authority Act, No. 05 of 2015, no medicine, medical device or border line product shall be manufactured or imported without registering such items with the National Medicines Regulatory Authority (NMRA).
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Hon.Pavithradevi Wanniarachchi,Minister of Health and Indigenous Medical Services informed that all the pharmacies should be opened to public on 2,3 and 6 April 2020.
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Implementation of the recommendations of the National Language Commission regarding labelling of Medicines
I wish to highlight you the following recommendations made by the Chairman, National Language Commission by letter No. OLC/C/177(a) dated 19.10.2012.- All information and advices labelled on medicines that can be brought from pharmacies and other sales outlets without a prescription or without the supervision of a pharmacist should be in accordance with the national language policy.
- With regard to prescription only medicines, information that a patient should be compulsorily aware of such as the name, directives for use, dose, important side effects, storage instructions, date of expiry etc. should be in accordance with the national language policy.
Point 1, above is already implemented for schedule I drugs as a patient information leaflet in both Sinhala and Tamil languages. On the directive of the Supreme Court related to case No. SC (FR) 102/2016, meetings of all relevant stakeholders were convened to explore the ways of implementing the national language policy for medicines classified under other schedules. Based on discussions that took place at these meetings, the National Medicines Regulatory Authority (NMRA) has decided to implement the following:
- With effect from 1" January 2020, the generic name of the finished product should be labelled in Sinhala and Tamil languages on all medicines. As some foreign manufacturers might find it not viable to have a customized label specifically to Sri Lanka due to lesser volume marketed in Sri Lanka, the NMRA would allow the respective marketing authorization holders to paste a sticker depicting the same information on the label. The sticker shall not cover essential information such as the batch number, date of expiry, storage recommendations and any precautionary statements.
- Also, marketing authorization holders would be required to insert a patient information leaflet. This requirement would be implemented step by step and NMRA has selected the following medicines in the initial step:
- Metformin
- Atorvastatin
- Losartan potassium
- Ciprofloxacin (oral dosage forms only)
- Co-amoxiclav (oral dosage forms only)
NMRA would publish the content for the patient information leaflet for each of above medicine and the date of implementation would be announced in due course.
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National Medicines Regulatory Authority (NMRA) recently launched their updated and newly integrated user friendly website.
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