National Medicines Regulatory Authority Act 2015 · As enacted · Part IV · General
65. Cancellation or suspension of registration and licence
Official English translation. Where it differs from the Sinhala or Tamil text, the Act itself says which text prevails.
Official translationFrom Department of Government Printing, unchanged
Where the Authority is of the opinion that –
the holder of certificate has failed to comply with any condition subject to which any medicine has been registered;
the medicine does not comply with any prescribed requirement;
it is not in the public interest that the medicine shall be available;
the medicine has not been imported to Sri Lanka within two years from the date of registration;
the holder of certificate has failed to comply with any direction of the Authority; or
the holder of certificate has violated any provision of this Act or any regulation made thereunder, the Authority shall cause notice of cancellation or suspension to be issued to the holder of certificate in respect of such medicine.
Any such notice shall specify the grounds on which the Authority’s opinion is based, and shall indicate that the holder of certificate may within one month after receipt thereof submit to the Authority in writing any comments he may wish to submit.
Where the holder of certificate fails to submit his comments within the time stipulated therefor or after consideration of any comments submitted, the
Authority may suspend or cancel the Certificate of
Registration and any related license and inform in writing the suspension or cancellation to the holder of certificate immediately.
Where the holder of certificate, does not apply for a renewal of such Certificate six months before its expiry date, the registration or licence of the medicine for which such
Certificate relates, shall be deemed to have automatically been cancelled.
Part V
General
Part VI
Rules and Regulations
Part VII
Repeals and Transitional Provisions
Part VIII