The Human Medicines Regulations 2012

Advanced therapy medicinal productsU.K.

5.  No provision of these Regulations that applies only to advanced therapy medicinal products shall apply until 30th December 2012 to advanced therapy medicinal products which—U.K.

(a)are tissue engineered products; and

(b)were legally on the market in the United Kingdom in accordance with United Kingdom or European Union legislation on 30th December 2008.