CHMP udvidede derfor, den 20. april 2005 efter anmodning fra Europa- Kommissionen og i henhold til artikel 31 i direktiv 2001/ 83/ EF, med senere ændringer, og gennemgangen af CHMP i henhold til artikel 18 i Rådets forordning (EF) nr.
Therefore, on 20 April 2005 further to a request from the EC, the CHMP broadened the scope of the procedure under Article 31 of Directive 2001/ 83/ EC, as amended and the review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, to include the assessment of serious skin reactions in the ongoing class review in addition to the cardiovascular safety aspects.