The European Medicines Agency is reminding pharmaceutical companies that a number of incentives related to fees for are expiring on 30 December 2012.
Regulation (EC) No 1394/2007
on advanced therapy medicinal products (the ‘ATMP Regulation’) introduced a number of fee-related incentives that were applicable during a transitional period. Some of these incentives, which were applicable to cell-based and gene-therapy medicines ended on 30 December 2011, but other incentives applicable to tissue-engineered products will end this December. These include:
- a 50% reduction in fees for marketing authorisation and for post-authorisation activities in the first year following the granting of the marketing authorisation (granted under Article 19 of the ATMP Regulation). These apply to hospitals or micro, small or medium-sized enterprises (SMEs) that proved that there was a particular public-health interest in the medicine concerned in the Community;
- a full waiver of fees for applications submitted for the authorisation of medicines that were legally on the European Union market in accordance with national or Union legislation on 30 December 2008 (granted under Article 29(3) of the ATMP Regulation).
A number of incentives for ATMPs will continue to apply after 30 December 2012. These include:
- fee reductions for scientific advice, i.e. a 90% reduction for SMEs and 65% for other applicants (granted under Article 16(2) of the ATMP Regulation);
- fee reductions for the certification procedure for SMEs submitting quality and non-clinical data (granted under Article 18 of the ATMP regulation);
- other possible fee incentives applicable to SME applicants and SME marketing-authorisation holders of ATMPs derived from Commission Regulation (EC) No 2049/2005 (the SME Regulation).