Before the trial can start in each country a regulatory approval from the country's regulatory authority must be applied for (click here for a list). The approval of the regulatory authority will ensure that they have no objections for the trial to be carried out in their country. This will also enable smooth import of the trial materials. In some cases a separate import licence is required. The national authority in your country will be able to advise you on this.

The coordinating centre will assist investigators in putting together the application pack, but in most cases the submission has to be done by the investigator. The coordinating centre will also deal with the authority's requests for further information or documentation. A regular and timely communication between the coordinating centre and the investigator must be maintained to process the application as quickly and efficiently as possible.

Trial materials cannot be sent to investigators until a national approval / import licence is valid.

Essential elements of a regulatory application:
EU COUNTRIES (Section J checklist)

NON-EU COUNTRIES