S.L. 458.42 Art. 5Conformity with good manufacturing practice.

(1) It shall be the duty of the manufacturer to ensure that manufacturing operations, including those of medicinal product intended only for export, and intermediate products, active substances and excipients, are carried out in accordance with European Union good manufacturing practice and with the manufacturing authorisation.

(2) It shall be the duty of the manufacturers and importers of active substances, including active substances that are intended for export, to comply with the current European Union good manufacturing practice for active substances.

(3) For medicinal products imported from third countries, the importer shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union and that such products have been manufactured by manufacturers duly authorised to do so.