Combined advanced therapy medicinal products
Article 9
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.