S.L. 458.47 Art. 2Application of provisions.

(1) The following provisions shall apply to investigational medicinal products for human use:

(a) the principles of good clinical practice and detailed guidelines in line with those principles, as referred to in Article 1(3) of Directive 2001/20/EC, for the design, conduct and reporting of clinical trials on human subjects involving such products;

(b) the requirements for authorisation of the manufacture or importation of such products, as provided for in Article 13(1) of Directive 2001/20/EC;

(c) the detailed guidelines, provided for in Article 15(5) of Directive 2001/20/EC, on the documentation relating to clinical trials, archiving, qualifications of inspectors and inspection procedures.

(2) (a) When applying the principles, detailed guidelines and requirements aforementioned, the Licensing Authority, hereinafter referred to as "the Authority", shall take into account the technical implementing modalities provided for in the detailed guidance published by the Commission in The Rules Governing Medicinal Products in the European Union.

(b) When applying the principles, detailed guidelines and requirements referred to in subregulation (1) to non-commercial clinical trials conducted by researchers without the participation of the pharmaceutical industry, the Authority may introduce specific modalities in order to take into account the specificity of these trials as far as regulations 8 to 19 are INVESTIGATIONAL MEDICINAL PRODUCTS (HUMAN USE)

concerned.

(3) The Authority may take into account the special position of trials whose planning does not require particular manufacturing or packaging processes, carried out with medicinal products with marketing authorisations within the meaning of Directive 2001/83/ EC, manufactured or imported in accordance with the same Directive and conducted on patients with the same characteristics as those covered by the indication specified in the marketing authorisation.

(4) Labelling of investigational medicinal products intended for trials of that nature may be subject to simplified provisions laid down in the good manufacturing practice guidelines on investigational medicinal products: Provided that the Authority shall inform the Commission as well as the other Member States of any specific modalities implemented in accordance with this subregulation.