gov lk

All marketing authorization holders of medicines are hereby informed that renewal of registrations which hold full registration certificate will be accepted as per the format prescribed in the published guideline GL-021- Guideline on Registration of Medicines (V 1.0 / Rev No :0 effective date: 15/10/2019) with effect from 15/05/2022.

Dossiers should be submitted before the expiry of the current full registration certificate to entitle this format. Sales details & price details should be enclosed with each application as per the published web notice.

Web access to the published guideline (Click here to view)

However, if there is any practical difficulty to comply with above format, those dossiers will be accepted till 31st December 2022 as per the CTD format.

Please note that all renewal dossiers should be submitted as per the new format with effect from 01st January 2023. 

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