MHRA Questions and Answers for Specials manufacturer’s Data Integrity Definitions and Guidance Revision 1 December 2014 Revision 1.1 March 2015 7 7 Original record True Copy: / Original record: Data as the file or format in which it was originally generated, preserving the integrity (accuracy, ...
'Specials'are unlicensed medicines which are manufactured under a manufacturer’s specialslicence (MS) for a special clinical need and are under the responsibility ofthe prescribing doctor. There is no requirement for QP certification ofproducts manufactured under the provisions of an MS. IMPs are g...