Examples of using Centralised procedure in English and their translations into Swedish
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Medicine
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it should be made subject to a centralised procedure.
feed are currently authorised in the EU through a centralised procedure under the Regulation(EC) No 1829/2003.
products approved via the mutual recognition procedure(MRP), decentralised procedure(DCP) and the Centralised procedure.
The EMEA was pleased to note that a member of the CPMP from Norway was appointed to act as co-rapporteur for a centralised procedure in 2000.
It is unanimously recognised the positive impact on the free movement of pharmaceuticals of the centralised procedure.
This centralised procedure has so far led to authorisations for 155 biotechnology or innovative medicines.
New applications submitted through the centralised procedure, for which applicants will have to pay a fee.
The centralised procedure in which the Commission grants a Community authorisation will be restricted to two categories of biocidal products: products based on new active substances and low-risk biocidal products.
The centralised procedure usually deals with highly innovative medicinal products,
An EMEA pre-submission guidance for users of the centralised procedure(EMEA/ H/ 38179/ 1998)
For the centralised procedure, as well as for the mutual recognition procedure, the number of variation applications is increasing dramatically.
The proposal states that the centralised procedure for the authorisation of medicinal products is to be extended beyond the present framework to all new substances appearing on the Community market.
Information on the centralised procedure for marketing authorisation is available on the European Medicines Agency(EMA) website.
Applications belonging to the Centralised Procedure must be submitted by the EMA eGateway and Common Repository.
These titles also apply to medicinal products authorised by the centralised procedure that is set out in the proposed Regulation.
A centralised procedure is followed when a marketing authorisation for new biotechnological products and other innovative medicinal products is applied for in all EU countries.
Applications for the centralised procedure shall be submitted via the EMA's eGateway
In the centralised procedure, a marketing authorisation is simultaneously applied for all EU countries, Norway and Iceland.
Many companies were in favour, in principle, of opening up the centralised procedure to other products.
First, the need to reinforce the role of the European Medicines Evaluation Agency and the centralised procedure.