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Public consultation (MLX 353): Consultation on advanced therapy medicinal products

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Document details:

Type: Publication
Series No: MLX 353
Audience: Healthcare professionals
Published: 23 July 2008
Format: Electronic and paper
Size: A4
Pages: 14
Price: Free
ISBN/ISSN:
Author: MHRA
Copyright: Crown
   

Related information:

MHRA pages:

MLX 353 seeks your views on proposals for the UK’s exemption scheme for advanced therapy medicinal products (ATMPs) under Article 28 (2) of Regulation EC No 1394/2007 (“the ATMP Regulation”). Alongside this are proposals for linked changes to the UK “Specials” regime (ie the national arrangements set up under a derogation in Article 5.1 of Directive 2001/83/EC) specifically in relation to those Specials that are ATMPs. The document also seeks views on the amendments that are required to the Medicines for Human Use (Marketing Authorisation etc) Regulations 1994 in order to introduce measures in the UK to enforce the obligations set out in the ATMP Regulation.

The deadline for response is 15 October 2008.

› Online response form for MLX 353

 

Page last modified: 23 July 2008