EU/420
WTO/TBT
CE Europäische Union
  • 11 - Medizintechnik
2017-01-08
2016-11-10

Medicinal products for human use

Draft Implementing Regulation on the detailed arrangements for the Good Clinical Practic einspections procedures, including the qualification and training requirements for inspectors (9 pages, in English)

This draft Implementing Regulation on the detailed arrangements for Good
Clinical Practice inspections procedures, including the qualification
and training requirements for inspectors, provides for, inter alia:

·   requirements as regards the experience, training and qualifications for GCP inspectors;

·   rules on conflict of interest and impartiality for GCP inspectors;

·   empowerment of inspectors and applicable confidentiality requirements;

·   obligation for the Member States to adopt detailed procedural rules, inter alia, for the appointment of experts accompanying inspectors, arranging inspections in third countries;

·   principle of mutual recognition of inspections findings and obligation of cooperation.