On 23 December 2005, orphan designation (EU/3/05/340) was granted by the European Commission Novartis Europharm Limited, United Kingdom, for imatinib mesilate for the treatment of myelodysplastic / myeloproliferative diseases. Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2012 on request of the sponsor.
The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use.
Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015.
Distribution of active substances comprise activities consisting of procuring, importing, holding, supplying or exporting active substances.
Active substances intended for the manufacture of veterinary medicines are exempted from these guidelines.
Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use
Stronger, clearer warnings on the risk of suicidal thoughts and behaviours are being incorporated into the prescribing information for drugs used in the management of Attention Deficit Hyperactivity Disorder (ADHD).