Procedure for evaluation and certification
Article 2
1. Applications for the scientific evaluation and certification of quality and non-clinical data relating to an advanced therapy medicinal product shall be submitted to the Agency and shall contain the following: (a) all information necessary to demonstrate that the applicant falls within the scope of this Regulation as set out in Article 1; (b) an indication as to whether the application relates to quality data only or to quality and non-clinical data; (c) a reference to any applications for certification previously submitted for the same advanced therapy medicinal product, an indication as to whether a certificate has been granted or not and an explanation of the added value of the new application and of the differences between the new application and the application previously submitted; (d) the relevant fee as provided for in Council Regulation (EC) No 297/95 ( 6 ) ; (e) the data referred to in module 3 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the second subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5. (f) where the application relates to both quality data and non-clinical data, the data referred to in module 4 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the third subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5. For the purposes of point (e) of the first subparagraph, the application shall contain at least the following data: (a) general information and information related to the starting and raw materials; (b) manufacturing process of the active substance(s), with the exception of data on process validation; (c) characterisation of the active substance(s), limited to the data necessary to adequately describe the active substance(s); (d) control of active substance(s), with the exception of data on the validation of the assays; (e) description and composition of the finished product. For the purposes of point (f) of the first subparagraph, the application shall contain at least the following data: (a) primary pharmacodynamic data supporting the rationale for the proposed therapeutic use; (b) pharmacokinetics bio-distribution data, if relevant to corroborate the primary pharmacodynamic data; (c) at least one toxicity study. 2. If the application fulfils the requirements laid down in paragraph 1 the Agency shall acknowledge receipt of a valid application. 3. The Committee for Advanced Therapies shall evaluate the valid application within 90 days following its acknowledgment of receipt. For the purposes of that evaluation, the Committee for Advanced Therapies shall, in particular with a view to the subsequent evaluation of any future application for clinical trial and marketing authorisation, determine whether: (a) the quality data submitted and the quality testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.3 and 3 of Part I, in Part IV and, where relevant to quality data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC; (b) where applicable, the non-clinical data and the non-clinical testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.4 and 4 of Part I, in Part IV and, where relevant to non-clinical data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC. 4. Within the period referred to in paragraph 3, the Committee for Advanced Therapies may request the applicant to provide supplementary information within a given time limit. In that case, the period referred to in paragraph 3 shall be suspended until the supplementary information requested has been provided. 5. When the Committee for Advanced Therapies has completed its evaluation, the Agency shall inform the applicant accordingly and provide him without delay with the following documents: (a) an evaluation report detailing in particular the reasons for the conclusion reached by the Committee for Advanced Therapies on the application; (b) if appropriate on the basis of this evaluation, a certificate identifying the quality and, where applicable, non-clinical data submitted and the corresponding testing methodologies followed by the applicant, which meet the scientific and technical requirements referred to in the second subparagraph of paragraph 3; (c) where deemed appropriate by the Committee for Advanced Therapies, a list of issues for future consideration by the applicant as regards the compliance with the scientific and technical requirements of Annex I to Directive 2001/83/EC of the quality and, where applicable, non-clinical data submitted, and the corresponding testing methodologies followed by the applicant.