Post-authorisation follow-up of efficacy and adverse reactions, and risk management
1. In addition to the requirements for pharmacovigilance laid down in Articles 21 to 29 of Regulation (EC) No 726/2004, the applicant shall detail, in the marketing authorisation application, the measures envisaged to ensure the follow-up of efficacy of advanced therapy medicinal products and of adverse reactions thereto.
2. Where there is particular cause for concern, the Commission shall, on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
In addition, the Agency may request submission of additional reports evaluating the effectiveness of any risk management system and the results of any such studies performed.
Evaluation of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 24(3) of Regulation (EC) No 726/2004.
3. The Agency shall forthwith inform the Commission if it finds that the marketing authorisation holder has failed to comply with the requirements referred to in paragraph 2.
4. The Agency shall draw up detailed guidelines relating to the application of paragraphs 1, 2 and 3.
5. If serious adverse events or reactions occur in relation to a combined advanced therapy medicinal product, the Agency shall inform the relevant national competent authorities responsible for implementing Directives 90/385/EEC, 93/42/EEC and 2004/23/EC.
Traceability
1. The holder of a marketing authorisation for an advanced therapy medicinal product shall establish and maintain a system ensuring that the individual product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used.
2. The hospital, institution or private practice where the advanced therapy medicinal product is used shall establish and maintain a system for patient and product traceability. That system shall contain sufficient detail to allow linking of each product to the patient who received it and vice versa.
3. Where an advanced therapy medicinal product contains human cells or tissues, the marketing authorisation holder, as well as the hospital, institution or private practice where the product is used, shall ensure that the traceability systems established in accordance with paragraphs 1 and 2 of this Article are complementary to, and compatible with, the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells.
4. The marketing authorisation holder shall keep the data referred to in paragraph 1 for a minimum of 30 years after the expiry date of the product, or longer if required by the Commission as a term of the marketing authorisation.
5. In case of bankruptcy or liquidation of the marketing authorisation holder, and in the event that the marketing authorisation is not transferred to another legal entity, the data referred to in paragraph 1 shall be transferred to the Agency.
6. In the event that the marketing authorisation is suspended, revoked or withdrawn, the holder of the marketing authorisation shall remain subject to the obligations laid down in paragraphs 1, 3 and 4.
7. The Commission shall draw up detailed guidelines relating to the application of paragraphs 1 to 6, in particular the type and amount of data referred to in paragraph 1.
