Examples of using Mutual recognition procedure in English and their translations into Slovak
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Having considered the referral notification and responses of the applicant, the CVMP concluded that all concerned member states in the mutual recognition procedure agreed that Compagel Gel for Horses is essentially similar to Tensolvet 50000.
whether it is a national authorisation, mutual recognition procedure or centralised procedure for a medicinal product.
Gedeon Richter Plc submitted a Marketing Authorisation Application(MAA) via mutual recognition procedure for Lisonorm on the basis of the marketing authorisation granted by Hungary on 30 April 2004.
except in FR since the approval given in Mutual Recognition Procedure in 2000.
was originally granted to AstraZeneca in The Netherlands on 6 November 2002 and a Mutual Recognition Procedure was started on 7 December 2002.
The Applicant/ MAH submitted an application for a Marketing Authorisation through the mutual recognition procedure for Menitorix on the basis of the marketing authorisation granted by the UK.
The application for UMAN BIG 180 IU/ ml solution for injection was submitted through the Mutual Recognition Procedure, on the basis of the marketing authorisation granted by the RMS(Italy) on the 2nd of June 1979.
spinal magnetic resonance imaging”(MRI) in Germany in January 2000 and subsequently in July 2001 in Spain via the mutual recognition procedure.
In addition, Article 30 of the Commission proposal provides that applications referred to in Article 9 relating to products authorised through the mutual recognition procedure may obtain an opinion from the Committee on Human Medicinal Products of the Agency.
Member States competent authorities, who have to apply different rules depending on whether they deal with a purely national authorisation, a mutual recognition procedure or a centralised authorisation.
following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
and SK,) through the Mutual Recognition Procedure with Hungary acting as the reference member state.
following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Actira film-coated tablets to Germany as Reference Member State(RMS)
the same use and under the same conditions for use in that Member State under the mutual recognition procedure provided for in Article 25.
Opinion in case of disagreement during mutual recognition procedures.
MUTUAL RECOGNITION PROCEDURES.
This became obvious in mutual recognition procedures for other lansoprazole containing products in which the involved member states could not agree on the therapeutic indications