gov lk

 

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.

1. Profile creation

2. Submission for product classification

3. Obtained the Sample Import Licenses

4. Submit the registration dossier

 

 

The following conditions should be strictly followed by the pharmacist/s and staff during opening hours.

  1. Maintain the minimum distance of 1 m between each customer and dispensing pharmacist to ensure social distancing.
  2. Hand sanitizing facility should be available at the entrance to the pharmacy and customers should disinfect hands thoroughly before entering the pharmacy.
  3. 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.

 

Guideline on procedure for expedited Marketing Authorization for Emergency use permission, Registration/Licensing of COVID 19 vaccines in Sri Lanka

The National Medicines Regulatory Authority accepts applications of vaccines against COVID 19 to be considered for emergency use authorization / registration. COVID 19 vaccines are eligible for rapid regulatory review under section 109 of the NMRA Act No. 5 of 2015 and related guidelines. 

Expression of Interest (EOI) to National Medicines Regulatory Authority by Applicant of COVID-19 vaccines

Application format for Expedited Marketing Authorisation

 

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.

120, Norris Canal Road, Colombo 10
 011-2687743
 info@nmra.gov.lk