Donation, procurement and testing
Article 3
Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with Directive 2004/23/EC.
Regulation (EC) No 1394/2007 CHAPTER 2 — MARKETING AUTHORISATION REQUIREMENTS
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Clinical trials
Article 4
1. The rules set out in Article 6(7) and Article 9(4) and (6) of Directive 2001/20/EC in respect of gene therapy and somatic cell therapy medicinal products shall apply to tissue engineered products. 2. The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
Good manufacturing practice
Article 5
The Commission shall, after consulting the Agency, draw up guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products.
Issues specific to medical devices
Article 6
1. A medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex I to Directive 93/42/EEC. 2. An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex 1 to Directive 90/385/EEC.
Specific requirements for advanced therapy medicinal products containing devices
Article 7
In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of an advanced therapy medicinal product containing medical devices, bio-materials, scaffolds or matrices shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.
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