- The requirements apply to the European Economic Area- and not just to the EU- and hence include Iceland, Lichtenstein and Norway.
- The requirement to provide details for a medical device is restricted to those devices defined under the advanced therapy legislation and hence the scope is very limited and does not cover administration devices.
- The information on details of manufacturing processes is not required by July 2, 2012 but will be required when the International Organization for Standardization (ISO ) standards for Identification of Medicinal Products (IDMP) are fully implemented in 2015.
- Investigational medicinal products are not covered by the Article 57 legislation on pharmacovigilance but under the Clinical Trials Directive. The EMA will be issuing a notice shortly about the transition of IMPs to the use of the new specification but it is anticipated that this will be a requirement to implement the standard from February 2012 for new or updated records but not require an update for all IMPs. Although the same technical specification as for authorized products will be used, significantly fewer business rules will be applied to IMPs.
In addition, two sets of controlled vocabularies have been issued which supported the Structured Substance Information (SSI). Further sets of vocabularies will be issued in the near future to be used with the XEVPRM itself, together with a conventions document to be used for naming of substances.