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 ?
In addition to the Mutual Recognition Procedure in Europe, Allergan is working with other health regulatory agencies around the world to bring this valuable minimally invasive treatment option to people living with multiple sclerosis or spinal cord injury who have urinary incontinence due to neurogenic detrusor overactivity.
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.
The Mutual Recognition Procedure is a pan-European regulatory procedure to obtain marketing authorizations in European Union countries based on mutual recognition of marketing authorization in one member EU country (Reference Member State).
OSS, The Netherlands, June 19 /PRNewswire/ -- Organon announced today that NuvaRing(R) (etonogestrel/ethinyl estradiol vaginal ring), the company's once-a-month contraceptive, has successfully completed the European Mutual Recognition Procedure (MRP) in an additional 13 countries (1).
The Dutch regulatory approval triggers a mutual recognition procedure involving other European countries.
Roche announced the start of the Mutual Recognition Procedure for a COPEGUS(R) (ribavirin) 400 mg tablet, following approval by the Dutch Medicines Evaluation Board, the EU Reference Member State.
Reminyl will subsequently be submitted through the EU Mutual Recognition Procedure to gain marketing approval in Europe.
This was the first step in a broader strategy to partner VANTAS and introduce the product across Europe utilizing the Mutual Recognition Procedure.
In the Mutual Recognition Procedure, a medicine is first authorized in one European Union Member State, in accordance with the national procedures of that country.
NYSE: AGN) today announced that it received positive opinions for COMBIGAN(TM), Allergan's ALPHAGAN(R)/timolol combination product for glaucoma (brimonidine tartrate/timolol ophthalmic solution), from all twenty-one Concerned Member States included in the COMBIGAN(TM) Mutual Recognition Procedure (MRP) for the European Union.
It is a new unique "three-in-one" product concept which has been approved by the EEC Health Authorities through the mutual recognition procedure.
Hexvix has received approval for the diagnosis of bladder cancer in a large number of European countries through the European mutual recognition procedure with more expected in the near future.