
This month the European Medicines Agency (EMEA) published some new QRD documents updates. These included a
List of frequently used non-standard abbreviations to be used in SPC and labelling. This is version 9 of the original list: it runs for three pages and contains around 30 terms and their non-standard abbreviations in 23 languages. There are warnings that some terms have abbreviations in some languages only, while in others the full term must be used (eg there is no Portuguese abbreviation for "percutaneous transluminal coronary angioplasty". The notice contains no indication as to the list's legal status.
STOP PRESS: it now seems that the "SPCs" mentioned here are themselves a non-standard abbreviation for "Summaries of Product Characteristics", referred to as SmPCs by those who like to distinguish them from supplemtary-protection-certificate-type SPCs . Thanks, Trevor Cook (Bird & Bird) for pointing this out.
No comments:
Post a Comment