Examples of 'centralised procedure' in a sentence
Meaning of "centralised procedure"
Centralised procedure refers to a regulatory process in the European Union (EU) for the approval and marketing authorization of certain medical products, specifically pharmaceutical drugs. It involves a centralized review and decision-making process by the European Medicines Agency (EMA) on behalf of all EU member states. This procedure ensures consistent evaluation and approval of medicines across the EU market, promoting harmonization and accessibility of safe and effective treatments
How to use "centralised procedure" in a sentence
Basic
Advanced
centralised procedure
Through the centralised procedure must have.
Applications submitted for the centralised procedure.
The centralised procedure itself is not to be changed substantially.
These firms favoured a more centralised procedure.
The centralised procedure itself is not changed substantially.
Decision making process within the centralised procedure.
The switch to a centralised procedure was seen as very beneficial.
Continue to monitor all phases of the centralised procedure.
Centralised procedure for medicinal products for human use.
Time required for centralised procedure remains low.
New veterinary medicinal products authorised by centralised procedure.
Implementation of a centralised procedure of authorisation.
Medicinal products authorised according to the centralised procedure.
The centralised procedure.
Processing of renewals in the centralised procedure.
See also
Cope of the centralised procedure for granting marketing authorisation for medicinal products.
Mandatory scope of the centralised procedure.
The decentralised procedure should be replaced by a centralised procedure at EU level.
Optional scope of the centralised procedure.
The Agency should coordinate the controls of veterinary medicinal products authorised by the centralised procedure.
Operation of the centralised procedure.
Orphan designated medicines will also be covered by the mandatory centralised procedure.
For products through the centralised procedure within the.
Acceptability of invented names for veterinary medicinal products processed through the centralised procedure.
Applications centralised procedure.
Activities in relation to the key steps of the centralised procedure.
This was particularly so with the centralised procedure which was seen as new and untested.
The scope of these procedures is linked to that of the centralised procedure.
It has therefore proposed that the decentralised procedure be integrated into the centralised procedure.
Preparation for inclusion of new mandatory therapeutic areas within the scope of the centralised procedure.
There will be only one centralised procedure for the assessment and authorisation of novel foods.
This also helps the operation of the centralised procedure.
Compelling registration via the centralised procedure may mean the product is not registered at all.
Applications for medicinal products containing a new active substance may use the centralised procedure.
The proposal would establish a centralised procedure for authorising the marketing of advanced therapy products.
These data are assessed in accordance with a Centralised procedure.
Withdrawal of applications in the centralised procedure is possible before the CPMP issues an opinion.
The most serious criminal cases are now dealt with under a centralised procedure in Dublin.
In the case of the Centralised Procedure an application is made to the EMEA.
Firstly, on the extension of the scope of the centralised procedure.
In actual fact, the centralised procedure will only focus on some illnesses.
Management and follow-up of marketing authorisation applications under the centralised procedure.
A marketing authorisation granted following the centralised procedure is valid for the entire Community market.
The centralised procedure is compulsory for new marketing-authorisation applications for,.
The changes include, the opening of the centralised procedure to more types of new medicines.
The centralised procedure would also be positive for small and medium-sized enterprises.
Establish scientific advisory groups, in particular for mandatory therapeutic fields of the centralised procedure.
Currently, the centralised procedure must be used for the authorisation of biotechnology products.
The certificates confirm the marketing-authorisation status of products authorised through the centralised procedure.
Mr President, the centralised procedure is our preferred choice.
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