Site visits
Article 3
The Committee for Advanced Therapies may inform the applicant that a site visit of the premises where the advanced therapy medicinal product concerned is being developed is necessary in order to complete its evaluation in accordance with Article 2. It shall inform the applicant of the objectives of the site visit. If the applicant accepts the conduct of a site visit, it shall be carried out by inspectors from the Member States who hold the appropriate qualifications. In that case, the time-limit laid down in Article 2(3) shall be suspended until the visit report has been made available to the Committee for Advanced Therapies and to the applicant.