Please be informed that the public day for Market Authorization Holders (MAH) of Medicines will be held on every Thursday starting from 24th August 2023 at 9.00 to 3.30 pm at NMRA premises.
Maximum allowed participants are as follows;
SLCPI Members - 7
Non SLCPI Members - 3
Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) will be issued appointments for SLCPI members.
Non SLCPI Members - Appointments can be collected from NMRA on every Tuesdays during office hours.
Your kind co-operation in this regard will be highly appreciated.
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To all Marketing Authorization Holders of Medical Devices, are hereby informed that Medical Device Dossiers will be accepted on 3rd of August 2023 instead of 01st of August 2023 due to the public holiday (Poya day). Sorry for the inconveniences caused.
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To All Importers of Medical Devices
All importers of medical devices are hereby informed to submit following documents for the acceptance of new dossiers and re-registration dossiers of medical devices
Required documents for the new dossiers and re-registration dossiers of medical devices
- Comprehensive table of content (Index)
- Application form signed by authorized person (schedule 1 Form A / Form B)
- Letter of authorization from legal manufacturer
- Copy of foreign manufacturing site approval letter (If applicable)
- Copy of GMP report issued by NMRA for locally manufactured products
- Copy of sample license (for New)/ previous registration (for RR)
- Original free sale certificate issued by relevant health authority
- Hygienic certificate (If applicable)
- ISO certificate
- EC certificate
- EC design examination certificate (If applicable)
- COA /Finished product inspection report
- Stability report with protocol & declaration of shelf life (If applicable)
- Sterility report (If applicable)
- EO residual test report (If applicable)
- Electrical safety data report (If applicable)
- Performance evaluation test report for IVD (If applicable)
- Biological evaluation report (If applicable)
- Third party test report (If applicable)
- Bovine Spongiform encephalopathy (BSE) report (If applicable)
- Atomic energy authority approval for radiation emitting devices
- List of countries with evidence for other country registration
- List of standard accessories, spare parts, reagent & consumables (If applicable)
- Instruction for use (IFU) for IVD kits
- Product labels-Original/ Artwork/ Draft & product catalogue
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All marketing authorization holders of cosmetics are hereby informed that Cosmetic dossiers will be accepted on the 20th Thursday, July 2023 instead of 19th Wednesday, July 2023 due to unavoidable circumstance. Sorry for the inconvenience caused.
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To All Importers of Medical Devices
All importers of Medical Devices are hereby informed to include ten (10) models with minor changes which do not affect the quality, safety or effectiveness of the device or intended use for each registration certificate in the future.
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