S.L. 458.42 ст. 4Inspections.

(1) The Authority shall, by means of repeated inspections in the case of medicinal products for human use, ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by these regulations.

(2) The Authority shall, by means of repeated inspections, ensure that manufacturers and importers of active substances, including active substances that are intended for export, comply with European Union good manufacturing practice for active substances.

(3) The Authority shall also take into account the compilation, published by the Commission, of Community procedures on inspections and exchange of information.

(4) For the interpretation of the principles and guidelines of good manufacturing practice, the Authority and the manufacturers shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC, published by the Commission in the "Guide to good manufacturing practice for medicinal products and for investigational medicinal products". In the case of advanced therapy medicinal products, the guidelines on good manufacturing practice specific to advanced therapy medicinal products referred to in Article 5 of Regulation No. 1394/2007/EC on advanced therapy medicinal products shall be taken into account.

(5) The Medicines Authority shall establish and implement in its inspectorate a properly designed quality system that shall be complied with by inspectorates' personnel and management. The quality system shall be updated as appropriate.