"The European Commission has extended the consultation period for the revision of Annex 13 of the GMP Guide until 31 January 2009 following the addition of an explanatory note concerning reconstitution. Under the conditions stated in article 9(2) of Directive 2005/28/EC reconstitution prior to use is not subject to the holding of a manufacturing authorisation. Click here to find the updated draft Annex 13."
The initial draft was released in April 2008 (see GMP-News)
Cited from: EMEA Inspections
On behalf of the European Compliance Academy (ECA)