SME Office
Article 11
1. The Executive Director of the Agency shall set up dedicated administrative structures and specific procedures for the establishment of an SME Office. 2. The SME Office shall have the following tasks: (a) to give advice to applicants on the administrative and procedural steps necessary to comply with the requirements laid down in Regulation (EC) No 726/2004; (b) to ensure the appropriate monitoring of all requests and applications submitted by the same applicant and related to a particular medicinal product; (c) to organise workshops and training sessions for applicants on the administrative and procedural steps necessary to comply with the requirements laid down in Regulation (EC) No 726/2004.