Examples of using Centralised 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
Applications centralised procedure.
A centralised procedure, in which the Commission grants an authorisation;
Yes yes yes via the centralised procedure.
The decentralised procedure should be replaced by a centralised procedure at EU level.
Withdrawal of applications in the centralised procedure 1995-2000.
The orphan medicines centralised procedure in Europe, from a request for orphan designation to marketing authorisation, is displayed in this document below.
Management of Type I Variations in the Centralised Procedure CPMP/260/96.
There will be only one centralised procedure for the assessment and authorisation of novel foods.
CPMP opinions on initial applications in the centralised procedure 1995-2000.
In actual fact, the centralised procedure will only focus on some illnesses.
Many companies were in favour, in principle, of opening up the centralised procedure to other products.
The switch to a centralised procedure was seen as very beneficial.
The Agency should coordinate thecontrols of veterinary medicinal products authorised by the centralised procedure.
By consensus for the first application submitted under the new centralised procedure in September 1996 and trans- mitted to the European Commission.
Parliament has requested anextension of the compulsory field of application of the compulsory centralised procedure.
The proposal lays down a centralised procedure by which the Commission will authorise the placing on the market and use of feed additives.
The EMEA was pleased to note that a member of the CPMP fromNorway was appointed to act as co-rapporteur for a centralised procedure in 2000.
Another point of the agreement regards the development of an EMEA centralised procedure for the marketing authorisation of new medicinal products.
The centralised procedure usually deals with highly innovative medicinal products, either biotechnological compounds or new active substances.
This compromise allows the settlement of a number of important questions and a dynamic approach to the tasks of the agency andthe scope of this centralised procedure.
It is necessary to apply a harmonised centralised procedure for safety assessment and authorisation that is efficient, time-limited and transparent.
In the light of experience to be acquired in the implementation of this Regulation,the Commission will consider the need for a centralised procedure under Directive 2001/18/EC.
For medicinal productsother than those that have to be authorised via the mandatory centralised procedure, an abridged application can be filed after eight years and no additional year may be obtained.
Parliament adopted amendments to bring the period of data protection intoline with the period applicable to products authorised under the centralised procedure see above, point 4.2.1.
The field of application of the centralised procedure should also include medicinal products used within the framework of Community provisions regarding prophylactic measures for epizootic diseases.
The process for the organisation and coordination of pre-authorisation inspections for applications under the centralised procedure has been consolidated and is now a routine task.
A centralised procedure at Community level will ensure the safe utilisation of those products, prevent distortions in trade and guarantee comparable trading conditions for the placing on the market.
Together with the pharmaceutical industry, an ongoing cycle of questionnairesis organised to assess the performance of the Agency and the centralised procedure.
For immunological veterinary medicinal products authorised under the centralised procedure, the list of tests to be repeated by the control laboratory may be reduced only upon agreement of the Agency.
It does notseem consistent to admit amendments requested in a centralised procedure after grant, but not amendments requested before grant.