NATIONAL MONITORING PROGRAM

In accordance with part A of the annex to Decree-Law no. 95/2000, the GLP National Monitoring Program (NMP) of each competent Authority for this purpose must be prepared and made public: this must ensure that the test facilities adequately implement the GLP Principles in carrying out the studies and are in a position to guarantee the adequate quality of the data resulting from them. Thus, IPQ as the National OECD GLP Principles Monitoring Authority, for the area of industrial chemicals, has published its GLP/NMP, which aims to provide instructions for test facilities that conduct studies within the scope of these Principles.

The scope and extension of the GLP/NMP of IPQ are defined in Decree-Law No. 95/2000 and Decree-Law No. 99/2000. These diplomas make direct reference to the OECD GLP Principles, revised in 1997, and correspond to the provisions contained in Directives 2004/9/EC and 2004/10/EC, regarding the operation of the NMP/GLP.

The GLP/NMP applies to safety studies of all chemical substances, including physical-chemical, toxicological and ecotoxicological studies, as well as field studies. According to point 2 of article 2 of Decree-Law no. 99/2000, “Except when exempted by specific legislation, this law is still applicable to non-clinical studies of safety for health and the environment, required by regulation for the purpose of licensing or registering pharmaceutical products, pesticides, food additives, feed additives, cosmetics, veterinary drugs and similar products, as well as for the regulation of industrial chemicals ”.

The GLP National Monitoring of IPQ can be consulted here.