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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.

NMRA will reconsider this decision to be revoked, if the country is declared as “COVID 19 free nation” by the Health Authorities.

II. Extension of approval to import of products which are less than 75% of shelflife up to 31st December 2020.

NMRA has decided to give following concession,

• For Medicines at least 6 month of shelf life to be retained with the product at the time of importing.• For parenterals at least 12 month of shelf life to be retained with the product at the time of importing.• For Vaccines prior approval to be required from the NMRA if the shelf life is below than the 66%.

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