S.L. 427.56 Art. 4Certification of results. verification of Good Laboratory Practice.

Where a laboratory has carried out a test in accordance with regulation 2(1), it shall give a notice in writing to the person verification of the organizational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.

(2) This regulation is not concerned with the interpretation and evaluation of test results.

(3) The compliance with Good Laboratory Practice of any testing laboratory claiming to use Good Laboratory Practice in the conduct of tests on chemicals shall be verified using the procedure laid down in this regulation.

(4) Where the provisions of subregulation (3) have been complied with, and the results of the inspection and verification are satisfactory, the competent authority may provide endorsement of a claim by a laboratory that it and the tests that it carries out comply with Good Laboratory Practice, using the formula ‘Assessment of conformity with Good Laboratory Practice according to Directive 2004/9/EC on ........................... (date)’.

(5) The competent authority shall inspect the laboratory and audit the studies in accordance with the provisions laid down in the Second Schedule.

(6) The competent authority shall ensure that commercially sensitive and other confidential information to which it gains access as a result of Good Laboratory Practice compliance monitoring activities is made available only to those national and international bodies which the Minister may, from time to time, designate, and to a laboratory or study sponsor directly concerned with a particular inspection or study audit.

(7) The names of the laboratories subject to inspection by the competent authority, their Good Laboratory Practice compliance status and the dates upon which laboratory inspections or study audits have been conducted shall not be considered to be confidential.