New regulatory application for MS cannabis spray Sativex®
Posted: Sun Jul 21, 2013 11:49 pm
New regulatory application for MS cannabis spray Sativex® approval in France
GW Pharmaceuticals plc announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) seeking to expand the marketing authorisation for Sativex® into France for the treatment of spasticity due to Multiple Sclerosis (MS).
This new regulatory application follows a Decree signed by the French Minister of Health in June 2013, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority. As with previous Sativex MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.... Read More - http://www.ms-uk.org/index.cfm/sativex
GW Pharmaceuticals plc announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) seeking to expand the marketing authorisation for Sativex® into France for the treatment of spasticity due to Multiple Sclerosis (MS).
This new regulatory application follows a Decree signed by the French Minister of Health in June 2013, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority. As with previous Sativex MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.... Read More - http://www.ms-uk.org/index.cfm/sativex