# Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (Text with EEA relevance), Article 11: SME Office

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2005/2049/article/11 (the official version)
Page: https://openlegislation.uk/eu-regulation-2005-2049/article-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.