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).
However, with the objective of assuring urgent availability of the face masks, personal protective equipment, IR thermometers, PCR kits and machines and hand sanitizers required for battling against the pandemic COVID 19, the NMRA had temporarily waived off the requirement for registration for the said items.
At present, since the COVID 19 is under control and adequate stock of the above items have already been imported to fulfill the requirement of Sri Lanka, the NMRA has decided to restrict issuing waiver of registration (WOR) for the said articles. Accordingly, applications would no longer be accepted for the WOR with effect from 26th June 2020 and the applicants are advised to obtain registration for the same before importation of above-mentioned products as per requirements of the NMRA Act.
Those who have already applied for the WOR are hereby informed to submit the requested documents and the samples on or before 26th June 2020.
Please note that the NMRA would be compelled to reject the applications for WOR which do not fulfil the above requirements within the specified time.
NMRA is not responsible for demurrages for above mentioned products which will be imported after 26th June 2020.
- Details
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).
However, with the objective of assuring urgent availability of the face masks, personal protective equipment, IR thermometers, PCR kits and machines and hand sanitizers required for battling against the pandemic COVID 19, the NMRA had temporarily waived off the requirement for registration for the said items.
At present, since the COVID 19 is under control and adequate stock of the above items have already been imported to fulfill the requirement of Sri Lanka, the NMRA has decided to restrict issuing waiver of registration (WOR) for the said articles. Accordingly, applications would no longer be accepted for the WOR with effect from 26th June 2020 and the applicants are advised to obtain registration for the same before importation of above mentioned products as per requirements of the NMRA Act.
Those who have already applied for the WOR are hereby informed to submit the requested documents and the samples on or before 26th June 2020.
Please note that the NMRA would be compelled to reject the applications for WOR which do not fulfil the above requirements within the specified time.
NMRA is not responsible for demurrages for above mentioned products which will be imported after 26th June 2020.
- Details
To all representatives of companies,
All authorized agents for pharmaceuticals are hereby informed that NMRA would entertain applications for registration of Frusemide (Furosemide) Iv Injection on priority and expedited review basis.
Chief Executive Officer NMRA- Details
To all representative of companies,
All authorized agents are hereby informed that NMRA will not be accepting any dossier (Medicine, Medical Devices & Borderline products) without following information:
- The retail price of the country of origin.
- The retail prices of the other countries the product is exported.
- The maximum retail price you are going to sell in Sri Lanka.
- Details
NMRA has decided to implement the following color codes for Warfarin tablets in order to prevent the confusion in identifying different strengths by the patients.
0.5 mg - White 1 mg - Brown 3 mg - Blue 5 mg - PinkFailing to abide this will create unnecessary problem when clearing at custom.
Chief Executive Officer NMRA- Details