Scientific recommendation on advanced therapy classification
Article 17
1. Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product. The Agency shall deliver this recommendation after consultation with the Commission and within 60 days after receipt of the request. 2. The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of commercial confidential nature.