CMDh News – November 2014
02.12.2014
CMDh News - November 2014
Outcome on the referral for testosterone-containing medicines
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a regulatory body representing EU Member States, has endorsed by consensus the recommendations of the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) on testosterone-containing medicines in the referral procedure under Article 31 of Directive 2001/83/EC of the European Parliament and Council. Testosterone-containing medicines should be used only when the testosterone lack is confirmed by signs and symptoms and laboratory tests. The product information is to be updated with warnings against the use of testosterone in suffering from severe heart, liver or renal diseases. Adopted variations in the summary of product characteristics and package leaflet should be implemented as type IB variations..
More information on the referral procedure is accessible on the EMA webpages, or here.
Outcome on the referral for valproate-containing medicines and related substances
The CMDh has endorsed by consensus the PRAC recommendations on the valproate - containing medicines and related active substances in the referral procedure under Article 31 of Directive 2001/83/EC of the European Parliament and Council. For these medicines warnings on the use of valproate medicines in women and girls will be strengthened due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb. In addition, the CMDh has agreed with the proposed risk minimisation measures and obligation for marketing authorisation holders to carry out a drug utilisation study to assess the risk minimisation measures and better investigate the valproate prescription practice. The adopted changes in the summary of product characteristics and package leaflet are to be implemented by applying for a type IB variation and the educational material should be attached at the same time.
More information on the referral procedure is accessible on the EMA webpages, or here.
Implementation of the outcome of the referral for Tazocin and associated names
An inconsistency has been detected in the product information for Tazocin and associated names as amended after the Article 30 referral (EMEA/H/A-30/1149) with regards to the dosing recommendation for the treatment of severe gastrointestinal infections in children aged 2 to 12. The correct wording of the package leaflet which is in line with Section 4.2 of the SmPC should be appropriately reflected in Section 3 of the package leaflet at the earliest regulatory opportunity, in coordination with the reference member state. It should be noted that no amendment is expected to the text currently published on the European Commission and EMA websites.. More information is available in the CMDh report.
Revision of Core Package Leaflet for Hormonal Replacement Therapy products
The CMDh has agreed a new version of the core package leaflet for hormonal replacement therapy products to include information on mammography in line with the Core SmPC. The concerned marketing authorisation holders are requested to update the package leaflet within one year with any other variation submitted under category C or via a Notification 61(3). The updated document will be published under "Product information, Core SmPC/PL”, or here.
The CMDh meeting report is accessible on the CMDh/HMA webpages, or here.
