Examples of using Decentralised procedure in English and their translations into Swedish
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Medicine
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Decentralised procedure- Fimea.
Chapter 4 Mutual recognition and decentralised procedure.
Decentralised procedure- fimea englanti- Fimea.
The original Article 6 setting up a decentralised procedure is deleted.
The Decentralised Procedure UK/ H/ 0892/ 01/ DC started on 12 April 2006.
Mutual recognition procedure and decentralised procedure.
Decentralised procedure: 210 says+ 30 days for the review of translations.
Mutual recognition procedure and decentralised procedure.
The Decentralised Procedure, SE/ H/ 575/ 07/ DC,
Marketing authorisations approved via mutual recognition or decentralised procedure.
Decentralised procedure subject to an Article 33 Referral CD 17 April 2008.
In 2014 the Parliament adopted a report3 expressing some opposition to the decentralised procedure.
The decentralised procedure should be replaced by a centralised procedure at EU level.
Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
The decentralised procedure applies in cases where a medicine has not received a marketing authorisation in any Member State.
It has therefore proposed that the decentralised procedure be integrated into the centralised procedure. .
The decentralised procedure(DCP) is used to apply for market authorisation for products not authorised in any EU member state.
in applications submitted via the decentralised procedure DCP.
In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
contains process descriptions and detailed instructions on the mutual recognition procedure and the decentralised procedure.
This decentralised procedure will include several of Bluefish's most important markets, with launches expected during 2016.
for a national procedure, mutual recognition procedure and decentralised procedure must be paid to Fimea.
There are also plans to reform the decentralised procedure(which applies, for example, to generic medicines) and the arbitration procedure. .
The Member State may also invoke the provisions of the first subparagraph in order to withhold marketing authorisation according to a decentralised procedure as provided for in Articles 31 to 43.
To apply in several member states the decentralised procedure(DCP) or mutual recognition procedure(MRP)
at day 210 of the decentralised procedure.
In the decentralised procedure, a new marketing authorisation is simultaneously applied for several(or even all) EU countries, Norway and Iceland.
defining its role in settling disagreements, in the context of a revised decentralised procedure.
Your argument in favour of the decentralised procedure in the area of new active substances is therefore unfounded, and has no bearing on our discussion today.
This will simplify the procedures for applying for a marketing authorisation for generic versions of these reference medicinal products under the mutual recognition or decentralised procedure.