Medicines and Allied Substances (Importation and Exportation) Regulations, 2017 (S.I. No. 57 of 2017).

These Regulations concern an importation permit issued under section 35 or an exportation permit issued under section 36 of the Medicines and Allied Substances Act, 2013. The Regulations provide for, among other things, the application for and issue of a permit and the transfer, amendment, suspension or cancellation of a permit. The Authority shall revoke a permit if (a) the permit holder contravenes the provisions of the Act or breaches the terms and conditions of the permit; (b) the permit holder fails to take corrective measures following the suspension of the permit; (c) it comes to the attention of the Authority that the medicines or allied substances in respect of which the permit was issued are not suitable or have become known to be dangerous or contain substances dangerous to human health, animal health or the environment; (d) the permit holder fails to comply with any other relevant written law; or (e) the permit holder obtained the permit by fraud or deliberate or negligent submission of false information or statements.