Examples of using Centralised procedure in English and their translations into German
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Official
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Medicine
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Ecclesiastic
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Political
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Computer
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Official/political
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Political
It is necessary to apply a harmonised centralised procedure for safety assessment
coordination of pre-authorisation inspections for applications under the centralised procedure has been consolidated
Regulation(EEC) No 2309/93 introduced the centralised procedure, which entered into force in 1995.
As in the case of the decisions which the Commission must take following applications for marketing authorisation under the centralised procedure, this process needs to be reorganised.
Option A: No EU action(Status Quo): Centralised procedure for evaluation of new AS without binding time limits option A1.
Many companies were in favour, in principle, of opening up the centralised procedure to other products.
Parliament has requested an extension of the compulsory field of application of the compulsory centralised procedure.
It also emerges from the report that the general principles previously established which govern the centralised procedure should be maintained.
The centralised procedure usually deals with highly innovative medicinal products,
The adjustment of the timeline for the remaining centralised procedure should help accelerate the investigation phase of the procedure. .
I advocate the option of choosing between a centralised procedure and national authorisation,
For those medicinal products not eligible for the centralised procedure, or where the applicant chooses not to follow the centralised procedure, the system provides for a mutual recognition procedure. .
that each could in principle also be settled on its own is not reconcilable either with the procedural provisions governing opposition as a centralised procedure or with the EPC's rules on patent maintenance or revocation in the interests of the public.
The centralised procedure would also be positive for small and medium-sized enterprises.
The Agency should coordinate the controls of veterinary medicinal products authorised by the centralised procedure.
Therefore, on the debate on the centralised procedure, I believe we must have flexibility.
The centralised procedure tends to be used predominately by large multi-national companies
Optional access to the centralised procedure should be maintained for veterinary medicinal products containing a new active substance.
The centralised procedure tends to be used predominantly by large multinational companies
Applications for variations to marketing authorisations granted under the centralised procedure essentially began in the latter half of 1996.