Where the Office does not consider the examination report to constitute a sufficient basis for decision, it may provide of its own motion, after consultation of the applicant, or on request of the applicant for complementary examination.

Subject to any arrangements which may have been concluded between the Community and third countries, the Commission, upon receipt of a reasoned request from a Member State or on its own initiative, or a Member State may propose that the trial site and/or the sponsor's premises and/or the manufacturer established in a third country undergo an inspection.

Wishing to have a coherent approach at European level and to act effectively against HIV/AIDS, malaria and tuberculosis in developing countries, Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom (hereinafter referred to as "the participating Member States") and Norway have taken the initiative, with developing countries, for setting up a research and development programme entitled "The European and Developing countries Clinical Trials Partnership" (hereinafter referred to as the EDCTP Programme) in order to obtain a critical mass in terms of human and financial resources and the combination of additional expertise and resources available in various countries across Europe and the developing countries.