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5. The licence holder must ensure that any blood or blood component imported into the United Kingdom and used by the manufacturer’s licence holder as a starting material or raw material in the manufacture of an exempt advanced therapy medicinal product meets equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components(1).
(1)
OJ No L 91, 30.3.2004, p. 25, as amended by Commission Directive 2011/38/EU, OJ No L 94, 12.4.2011, p. 28.