Examples of using Decentralised procedure in English and their translations into German
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Medicine
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Official
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Colloquial
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Ecclesiastic
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
But there was also concern about mutual recognition 6 in the decentralised procedure, where there were fears that the procedure would be crippled by challenges to the original assessment.
Pharmachemie BV submitted a Marketing Authorisation Application for Bleomycin powder for solution for injection 15 U/ vial in the decentralised procedure on 10 July 2007, the Netherlands acting as the reference member state.
the cost of 25 applications for market authorisation using the decentralised procedure will be much higher.
under the centralised procedure as well as the decentralised procedure, and even in the case of the accelerated procedure
the Commission has proposed that prescriptions would also be required for medicinal products under the decentralised procedure.
The decentralised procedure was acknowledged as having significant advantages in terms of optionality
The decentralised procedure was acknowledged as having significant advantages in terms of optionality
selling certain immunological veterinary medicinal products are extended to the marketing authorisation according to a decentralised procedure(Article 71(2), in conjunction with Article 33(1)procedure..">
For the decentralised procedure, it is proposed to set up a coordination group on the mutual recognition of veterinary medicinal products,
For the latter category the initial proposal included two different procedures:(a) a decentralised procedure, whereby a procuring entity would be allowed to exclude a tender after seeking the Commission's approval;
Mutual recognition procedure and decentralised procedure.
In a DCP(decentralised procedure) there is no existing authorisation of the medicine in any EU member state.
In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
If, for whatever reason, the sponsor of an orphan medicinal product prefers to use the decentralised procedure(mutual recognition),
Similarly, the mutual-recognition or decentralised procedure should be available as an option for medicinal products which represent a therapeutic innovation
The four procedures for obtaining authorisation to place a veterinary medicinal product on the market(centralised procedure, decentralised procedure, mutual recognition procedure and national procedure) are maintained with some changes.
new applications in the Decentralised Procedure(DCP) need to be filed in eCTD format(electronic Common Technical Document)
The protection period agreed in the current compromise, of eight years, plus two, plus one, for the centralised and the decentralised procedure, ensures, firstly, that there is
Reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures- Veterinary(CMD(v)) failed to reach an agreement for Equibactin vet.
Reference member state in the decentralised procedure, notified the EMEA on 21 December 2008 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures- Veterinary(CMD(v))