Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Translations
The Agency shall provide for the translations of the documents referred to in points (a) to (d) of Article 9(4) and points (a) to (e) of Article 34(4) of Regulation (EC) No 726/2004 that are required for the purpose of granting a Community marketing authorisation.
SME Office
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.
User Guide
The Agency shall, upon agreement of the Commission, publish a detailed User Guide on the administrative and procedural aspects of the provisions laid down in Regulation (EC) No 726/2004, which are of particular relevance for SMEs. The User Guide shall be kept updated. The User Guide shall also contain references to existing national provisions for SMEs applicable to the pharmaceutical sector. For the purposes of the second paragraph, the Member States shall communicate those references to the Agency.
Articles on this page are reproduced verbatim from official open data. See the attribution line.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.