(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.

(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.

(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.

(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.

(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.

(a)

seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notįfied body is not required; or

(b)

exclude from the evaluation the check of conformity of the medical device with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007.