NATIONAL AUTHORITY FOR MONITORING

Data on safety testing must be submitted to receiving authorities for marketing authorisation of the product. As part of the review process GLP compliance of the submitted data is verified. In addition, the GLP compliance status of the test facility at which the study was carried out, is checked by consulting information on inspections provided by the GLP National Monitoring Programmes (NMP).

OECD countries in which non-clinical health and environmental safety testing is carried out according to the OECD GLP Principles have established GLP/NMP with responsibilities for monitoring GLP compliance of test facilities within their territories. GLP compliance is verified by NMP through inspections of GLP test facilities, and audits of GLP studies. A test facility which has been subject to periodic inspections by a GLP/NMP and found to be operating in compliance with the Principles of GLP, is recognized as a GLP compliant test facility.

In most countries, facilities that wish to become recognized as GLP compliant can apply to the national CMP. The GLP/NMP then conducts an inspection to determine if the test facility complies with the OECD principles of GLP. In other countries, GLP/NMP can inspect any test facility claiming to conduct studies according to the GLP principles.

The Portuguese Institute for Quality, IP (IPQ) is a public institute, created in July 1986, with legal identity and administrative autonomy, under the terms of its Organic Law, approved by Decree-Law no. 71/2012, of 21 March, amended by Decree-Law no. 80/2014, of 15 May. IPQ’s mission is to coordinate the Portuguese Quality System and other regulatory qualification systems conferred by law, as well as to promote and coordinate activities that aim to contribute to demonstrating the credibility of the action of economic agents.

Within the scope of Decree-Law No. 95/2000, of 23 May, and Decree-Law No. 99/2000, of 30 May, which transposes Directives 2004/9/EC and 2004/10/EC, IPQ is designated as the National Authority for Monitoring the application of the OECD GLP principles in the execution of non-clinical tests and laboratory studies on chemical substances, included in the generic designation of chemical products. IPQ as a Competent Authority for the inspection and assessment of compliance with the provisions of Decree-Law no. 95/2000, is responsible for matters related to GLP for its area of competence, including contacts with Regulatory and Monitoring Authorities GLP, and domestic or foreign industry.