S.L. 458.42 Art. 16Importation of active substances. Cap. 458.

(1) Active substances shall only be imported if the following conditions are fulfilled:

(a) the active substances have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those laid down by the European Union pursuant to the third paragraph of Article 47; and

(b) the active substances are accompanied by a written confirmation from the competent authority of the exporting third country of the following:

(i) the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the European Union;

(ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the European Union; and

(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the European Union without any delay.

(2) This written confirmation shall be without prejudice to any other obligations set out in the Medicines Act and regulations and, or rules made thereunder. The requirement set out in sub-regulation (1)(b) shall not apply if the exporting country is included in the list published by the European Union Commission as referred to in Article 111b of Directive 2001/83/EC, as amended.

(3) Exceptionally and where necessary to ensure the availability of medicinal products, when a plant manufacturing an active substance for export has been inspected by a European Union Member State and was found to comply with the principles and guidelines of good manufacturing practice as defined in these regulations, the requirement set out in sub-regulation (1)(b) may be waived for a period not exceeding the validity of the certificate of good manufacturing practice. When such waiver is used, this shall be communicated to the European Union Commission.