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Adaptation of Annexes
The Commission shall, after consulting the Agency and in accordance with the regulatory procedure with scrutiny referred to in Article 26(3), amend Annexes I to IV in order to adapt them to scientific and technical evolution.
Report and review
By 30 December 2012, the Commission shall publish a general report on the application of this Regulation, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation. In this report, the Commission shall assess the impact of technical progress on the application of this Regulation. It shall also review the scope of this Regulation, including in particular the regulatory framework for combined advanced therapy medicinal products.
Committee procedure
1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121(1) of Directive 2001/83/EC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Amendments to Regulation (EC) No 726/2004
Regulation (EC) No 726/2004 is hereby amended as follows: 1. in the first subparagraph of Article 13(1), the first sentence shall be replaced by the following: ‘Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community.’; 2. Article 56 shall be amended as follows: (a) in paragraph 1, the following point shall be inserted: ‘(da) the Committee for Advanced Therapies;’ (b) in the first sentence of the first subparagraph of paragraph 2, the words ‘paragraph 1(a) to (d)’ shall be replaced by ‘paragraph 1(a) to (da)’; 3. the Annex shall be amended as follows: (a) the following point shall be inserted: ‘1a. Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products ( *1 ) . ( *1 ) OJ L 324, 10.12.2007, p. 121 ’;" (b) In point 3, the second subparagraph shall be replaced by the following: ‘After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.’
Amendments to Directive 2001/83/EC
Directive 2001/83/EC is hereby amended as follows: 1. in Article 1, the following point shall be inserted: ‘4a. Advanced therapy medicinal product: A product as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products ( *2 ) . ( *2 ) OJ L 324, 10.12.2007, p. 121 ’;" 2. in Article 3, the following point shall be added: ‘7. Any advanced therapy medicinal product, as defined in Regulation (EC) No 1394/2007, which is prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient. Manufacturing of these products shall be authorised by the competent authority of the Member State. Member States shall ensure that national traceability and pharmacovigilance requirements as well as the specific quality standards referred to in this paragraph are equivalent to those provided for at Community level in respect of advanced therapy medicinal products for which authorisation is required pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( *3 ) . ( *3 ) OJ L 136, 30.4.2004, p. 1 . Regulation as amended by Regulation (EC) No 1901/2006 ( OJ L 378, 27.12.2006, p. 1 ).’;" 3. in Article 4, the following paragraph shall be added: ‘5. This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells, on grounds not dealt with in the aforementioned Community legislation. The Member States shall communicate the national legislation concerned to the Commission. The Commission shall make this information publicly available in a register.’; 4. in Article 6(1), the first subparagraph shall be replaced by the following: ‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1394/2007.’
Transitional period
1. Advanced therapy medicinal products, other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation on 30 December 2008, shall comply with this Regulation no later than 30 December 2011. 2. Tissue engineered products which were legally on the Community market in accordance with national or Community legislation on 30 December 2008 shall comply with this Regulation no later than 30 December 2012. 3. By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraphs 1 and 2 of this Article.
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union . It shall apply from 30 December 2008.
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