# Council Decision of 28 July 1989 on the acceptance by the European Economic Community of an OECD decision/recommendation on compliance with principles of good laboratory practice (89/569/EEC), Appendix ANNEX III: GUIDANCE FOR THE EXCHANGE OF INFORMATION CONCERNING NATIONAL PROCEDURES FOR MONITORING COMPLIANCE

Extent: E+W+S+N.I.

Part II, paragraph 2 of the Council Act contains a Decision that Member States exchange information related to their procedures for monitoring compliance with GLP principles. This Annex provides guidance concerning the types of information which should be exchanged. While information concerning all of the aspects covered in the ‘guides for compliance monitoring procedures for good laboratory practice’ (Annex I) are relevant to an understanding of other Member States' procedures for GLP compliance monitoring, certain types of information are of particular importance. These include:
the GLP principles adopted nationally;
the scope of the national programme for monitoring compliance with GLP principles in terms of the types of chemicals and tests covered;
the identity, legal status, and organizational structure of the (national) GLP monitoring authority(ies);
the procedures followed during laboratory inspections and study audits, and the frequency of routine inspections;
the number and qualifications of inspectors;
the actions available to the (national) GLP monitoring authority(ies) in cases of non-compliance, including the ability to inform other Member States, when necessary, of the results of laboratory inspections and study audits;
the arrangements for protecting confidentiality of information;
the procedures for initiating, conducting and reporting on laboratory inspections and study audits at the request of other Member States;
the procedures for obtaining information on laboratories which have been inspected by a (national) GLP monitoring authority of another Member State, including such laboratories' compliance status;
and
the nature of laboratory certifications that studies were carried out following GLP principles.
Recognition of national procedures for monitoring compliance with GLP principles may not be immediately forthcoming from other Member States. Member States should be prepared to meet genuine concerns in a cooperative way. It may be that a Member State is unable to judge the acceptability of the GLP compliance monitoring procedures of another solely on the basis of the exchange of written information/In such cases, Member States may seek the assurance they require through consultation and discussion with relevant (national) GLP monitoring authorities. In this context, OECD provides a forum for the discussion and solving of problems relating to the international harmonization and acceptance of GLP compliance monitoring procedures.
To facilitate international liaison and the continuing exchange of information, the establishment of a single GLP monitoring authority covering all good laboratory practice activities within a Member State has obvious advantages. Where more than one authority exists, a Member State should ensure that they operate in a consistent way, using comparable procedures and having similar GLP compliance programmes. The authority or authorities with responsibilities for international contacts should be identified by Member States.
Situations will arise where a national regulatory authority of a Member State will need to request information on the GLP compliance status of a laboratory located in another Member State. On rare occasions, and where good reason exists, a particular study audit may be requested by a regulatory authority of another Member State. Arrangements should be provided whereby these requests may be fulfilled and the results reported back to the requesting regulatory authority.
Formal international contact should be established for the exchange of information between GLP monitoring authorities. However, this should not be understood to prevent informal contacts between regulatory authorities and the GLP monitoring authority in another Member State, to the extent that such contacts are accepted by the Member State concerned.
National authorities should note that authorities from another Member State, may wish to be present at a laboratory inspection or study audit that they have specifically requested; or they may wish that representative(s) from the Member State seeking a special laboratory inspection or study audit present at that inspection or audit. In these cases, Member States should enable inspectors from another Member State to participate in laboratory inspections and study audits carried out by their GLP monitoring authority.

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Source: https://www.legislation.gov.uk/eudn/1989/569/annex/1/annex/III (the official version)
Page: https://openlegislation.uk/eu-decision-1989-569/annex-1/annex-III
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.