APPLYING FOR COMPLIANCE ACCORDING TO THE PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP)
It allows the Entity (Test Facility – TF or Test Site – TS) to obtain compliance with the Principles of Good Laboratory Practice (GLP) from Organisation for Economic Co-operation and Development (OECD) to perform non-clinical testing and laboratory safety studies on chemical substances.
These studies are required for the registration of new products, which enables their introduction on to the market.
Who can apply for compliance?
Any national laboratory, public or private, wishing to declare the application of GLP in the conduct of non-clinical tests and laboratory studies on chemical substances.
When can you apply?
At any time.
How to apply?
Request the application form and instructions by bpl@ipq.pt.
What is the price to apply?
Consult the Regulation of prices for GLP / IPQ.
Procedure
Deadline for issuance/decision
A decision on recognition is taken about 1 month after receivingthe receipt of the TF’s or TS’s response to the inspection report carried out by the Portuguese Institute for Quality (IPQ).
Expiry date
2 years.
What is the support legislation?
- Decree-Law No. 95/2000 of 23 May (Concerning inspection and verification of the OECD Principles of Good Laboratory Practice)
- Decree-Law No. 99/2000 of 30 May (Rules concerning the application of the OECD principles of Good Laboratory Practice).
- Directive 2004/9/EC (On the inspection and verification of good laboratory practice)
- Directive 2004/10/EC (On the approximation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances).
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