mutual recognition procedure


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mutual recognition procedure

A reciprocity process under which EU member states recognise each others’ pharmaceutical marketing authorisations—unless the product is a threat to public health. Most new medicinals in the EU obtain their marketing authorisation by this mechanism.
References in periodicals archive ?
Biopharmaceutical company Sucampo Pharmaceuticals (NasdaqGM:SCMP) disclosed on Friday that it has completed the European Mutual Recognition Procedure (MRP) for AMITIZA for the treatment of chronic idiopathic constipation in select European countries.
Labopharm's lead in-house product, a once-daily formulation of the analgesic tramadol, has been approved in France and the company has initiated the Mutual Recognition Procedure process, which will facilitate regulatory approval across the European Union.
We are pleased that BOTOX[R] has received a positive opinion following the Mutual Recognition Procedure for the treatment of urinary incontinence in people living with multiple sclerosis or spinal cord injury," said Douglas Ingram, President of Allergan in Europe, Africa and the Middle East.
Glucophage IR is approved by a Mutual Recognition Procedure, where France acted as the Reference Member State.
Subject to the results of the study and to the required regulatory process, and in light of the data from prior successful studies conducted with RHB-103, RedHill and IntelGenx plan to submit a European MAA in the third quarter of 2014, with Germany as the reference member state, under the European Mutual Recognition Procedure.
Under its registration strategy, the company had filed in these countries first to ensure optimised registration timelines and then filed a mutual recognition procedure in France and Germany, which are two major European countries with the greatest commercial potential in the European herpes labialis market.
The Swedish company will carry out a mutual recognition procedure in the forthcoming months to secure marketing authorisation in the majority of the above mentioned countries.
The company says myfortic successfully completed the European Mutual Recognition Procedure (MRP) and was approved for the prevention of acute rejection of kidney allografts in adult patients on February 7, 2004.
BioAlliance Pharma SA (Euronext Paris - BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, announced today the approval of Loramyc([R])in 13 additional European countries(*) through a Mutual Recognition Procedure with France as reference member state.
M2 PHARMA-October 22, 2013-i" GW Pharmaceuticals completes European Mutual Recognition Procedure for Sativex oromucosal in France(C)2013 M2 COMMUNICATIONS
One daily intake of Seroquel XR (quetiapine fumarate extended-release tablets) and Seroquel (quetiapine fumarate) has been approved under the European Mutual Recognition Procedure for the stated indications in patients whose manic, mixed or depressive episode has responded to quetiapine treatment, AstraZeneca said in a statement.
UCB, Brussels, Belgium, has successfully completed the European Mutual Recognition Procedure (MRP) for Equasym(TM) XL for use in the treatment of the symptoms of attention deficit hyperactivity disorder (ADHD) with the UK acting as the Reference Member State for the MRP.