Examples of using Decentralised procedure in English and their translations into Hungarian
{-}
-
Medicine
-
Colloquial
-
Official
-
Ecclesiastic
-
Financial
-
Programming
-
Official/political
-
Computer
The Decentralised Procedure(DCP).
Mutual recognition procedure and decentralised procedure.
The decentralised procedure laid down in Articles 48 and 49;
The mutual recognition procedure and the decentralised procedure.
The Decentralised Procedure, SE/ H/ 575/ 07/ DC, started on 1 September 2006.
Mutual recognition procedure and decentralised procedure";
The decentralised procedure should be replaced by a centralised procedure at EU level.
(a) examine questions concerning mutual recognition and decentralised procedures;
The decentralised procedure applies in cases where a medicine has not received a marketing authorisation in any Member State.
Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products.
In August 2006 a Decentralised Procedure started with The Netherlands as Reference Member State and thirteen Concerned Member States.
Coordination groups for mutual-recognition and decentralised procedures(human and veterinary products).
In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
The matter wasreferred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
Furthermore, in the operation of the mutual recognition and decentralised procedures of Directive 2001/83/EC as amended by Directive 2004/27/EC, Member States have only 30 days from the assessment by the reference Member State to grant marketing authorisations.
The year 2006 is the first fullyear of operation of the Coordination Groups for Mutual-Recognition and Decentralised Procedures(CMDs) established by the new Community legislation.
Germany, reference member state in the decentralised procedure, notified the EMEA on 21 December2008 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures- Veterinary(CMD(v)) failed to reach an agreement for Compagel gel for horses.
The CHMP also endorsed the changes to the product information for themedicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.
The coordination group for mutual recognition and decentralised procedures for veterinary medicinal products("the coordination group") is hereby set up.
As zolpidem-containing medicines are all authorised nationally, the PRAC recommendations weresent to Co-ordination Group for Mutual Recognition and Decentralised Procedures- Human(CMDh), which adopted a final position.
The coordination group for mutual recognition and decentralised procedures for veterinary medicinal products(‘the coordination group') shall be set up.
As ambroxol- and bromhexine-containing medicines are all authorised nationally, the PRAC recommendation wasforwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures- Human(CMDh), for a position.
The matter wasreferred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use(CVMP).
In addition to the documentation already provided during the decentralised procedure, supporting a modest but certain role for bleomycin in the treatment of SCCHN, a number of recent reports support the role of bleomycin in conjunction with other chemotherapeutic moieties, identifying both a recovery ratio(RR) of 34% in second line treatment and the improvement of loco-regional control and survival in patients with advanced HNC through concomitant postoperative radio- and chemotherapeutical treatment with mitomycin C and bleomycin.
Where the variation concernsmarketing authorisations granted under the mutual recognition or decentralised procedures, a list of Member States which granted those marketing authorisations.
For the latter category theinitial 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; and(b) a centralised procedure, with the Commission playing a central role(investigation, negotiation with the third country, decision to adopt restrictive measures- a market closure or a price penalty- if necessary, which would then be applied by the national authorities in their procurement procedures). .
The four procedures for obtaining authorisation toplace a veterinary medicinal product on the market(centralised procedure, decentralised procedure, mutual recognition procedure and national procedure) are maintained with some changes.
Without prejudice to specificprovisions related to the mutual recognition procedure or the decentralised procedure, the competent authority or the Agency shall, within 15 days of receipt of the application, notify the applicant whether the formal requirements laid down in this Regulation for the application concerned have been met and whether the application can be subject to scientific assessment.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
(8) Wherever it is proposed to change the scope of the centralised procedure, it should no longerbe possible to opt for the mutual-recognition procedure or the decentralised procedure in respect of orphan medicinal products and medicinal products which contain new active substances and for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes.