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REACH

Information requirements and test methods and quality of data

What studies does ECHA accept as GLP studies?

In general, ECHA accepts data as GLP data where this data comes:

  • from countries that are OECD member states or full adherents to the OECD mutual acceptance of data (MAD) system; and
  • (from countries that are provisional adherents to the OECD MAD system and in which laboratories have been inspected jointly by the GLP monitoring authority concerned and by an OECD GLP monitoring authority.

Studies that are conducted in a laboratory situated in a country which has not joined the OECD MAD system can be accepted by ECHA as GLP compliant studies under the following conditions:

  • Before performing the study, the GLP compliance of the laboratory has been inspected by: an EU GLP monitoring authority (including Norway through EEA agreement); or GLP monitoring authorities in Israel, Japan and Switzerland with whom the EU holds mutual recognition agreements; or other GLP monitoring authorities of OECD member states or full adherents to the OECD mutual acceptance of data (MAD) system on a case-by-case basis; and
  •  The laboratory has been found to be operating in compliance with GLP principles.

http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm

See also Q&A 119.

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