The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has published two documents on unforeseen variations.
The document refers to Article 5 of Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and includes a timetable for dealing with these variations; the table has now been extended by adding the time slots for 2010.
The document (an MS Excel spreadsheet) also refers to Article 5 of the above Commission Regulation and reflects some recommendations on the classification of variations.
As part of the Heads of Medicines Agencies, the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) has published a number of interesting documents. Apart from the questions-and-answers sections, so-called Best Practice Guides provide valuable information on the point of view of the European registration and surveillance authorities.
The CMDh was established in the revised pharmaceutical legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any questions related to the marketing authorisation of a medicinal product in two or more member states under the mutual recognition procedure or the decentralised procedure. The CMDh started its activities in November 2005 and took the place of the informal Mutual Recognition Facilitation Group, which had been in operation for over 10 years in order to co-ordinate and facilitate the implementation of the mutual recognition procedure.
On behalf of the European Compliance Academy (ECA)