CHAPTER 3MARKETING AUTHORISATION PROCEDURE
Article 8Evaluation procedure
1.The Committee for Medicinal Products for Human Use shall consult the Committee for Advanced Therapies on any scientific assessment of advanced therapy medicinal products necessary to draw up the scientific opinions referred to in Article 5(2) and (3) of Regulation (EC) No 726/2004. The Committee for Advanced Therapies shall also be consulted in the event of re-examination of the opinion pursuant to Article 9(2) of Regulation (EC) No 726/2004.
2.When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus. If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members. The draft opinion shall mention the divergent positions and the grounds on which they are based.
3.The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the Chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) or Article 9(2) of Regulation (EC) No 726/2004 can be met.
4.Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
5.The Agency shall draw up specific procedures for the application of paragraphs 1 to 4.
Article 9Combined advanced therapy medicinal products
1.Where a combined advanced therapy medicinal product is concerned, the whole product shall be subject to final evaluation by the Agency.
2.The application for a marketing authorisation for a combined advanced therapy medicinal product shall include evidence of conformity with the essential requirements referred to in Article 6.
3.The application for a marketing authorisation for a combined advanced therapy medicinal product shall include, where available, the results of the assessment by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device part or active implantable medical device part.
The Agency shall recognise the results of that assessment in its evaluation of the medicinal product concerned.
The Agency may request the relevant notified body to transmit any information related to the results of its assessment. The notified body shall transmit the information within a period of one month.
If the application does not include the results of the assessment, the Agency shall 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 notified body is not required.