All marketing authorization holders of medicine are hereby informed that NMRA would not register new products, renew or issue import license of existing external preparations containing combinations of antifungal with potent or very potent steroids.
Combinations of antifungal with mild steroid can be considered for registration. The potency of steroid is considered as per the classification mentioned in the BNF.
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As per the announcement published on 25.08.2023 at NMRA offical website, applicants are informed to submit following documents.
1. Request letter for the certificate extension
2. Original GMP Certificate
3. Copy of the latest GMP report
Applicant can submit above mentioned documents on every Monday at the dossier accepting point to the manufacturing regulatory division's officals.
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All local manufactuers of Medicines, Medical Devices, Borderline Products and Cosmetics are hereby informed that the NMRA has decided to grant one year extension to the validity of the GMP certificates issued to Local Manuafcturers who are manufacturing Medicines (only for the category B), Medical Devices, Borderline Products (only for the external preparations) and Cosmetics
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All marketing authorization holders of cosmetics are hereby informed that cosmetic dossiers will be accepted on the 31st Thursday, August 2023 instead of 30th Wednesday, August 2023 due to unavoidable circumstance. Sorry for the inconvenience caused.
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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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