The European Commission (EC) is seeking views from stakeholders on the application of the Regulation on advanced therapy medicinal products (Regulation 1394/2007). Under the Regulation, the Commission is required to assess the application of the Regulation. The Commission has invited comments by 31 March 2013. A copy of the Commission’s consultation document can be found below.


Public consultation paper on the regulation of advanced therapy medicinal productsPDF file (opens in new window) (36Kb)


Further information can be found on the Commission’s website: (external link)


The MHRA will be responding to the Commission’s consultation and would be interested in seeing any responses submitted by UK stakeholders to the Commission’s consultation. UK respondents are encouraged to send copies of their responses to the MHRA by 15 March 2013, to allow them to be taken into account in formulating the MHRA’s response. If you would like to copy your response to the MHRA, please email it to