Examples of using Decentralised procedure in English and their translations into Danish
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Medicine
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Computer
The Decentralised Procedure UK/ H/ 0892/ 01/ DC started on 12 April 2006.
Informal meeting Coordination Group for the Mutual Recognition and Decentralised Procedures- Veterinary CMDv.
The Decentralised Procedure, SE/ H/ 575/ 07/ DC, started on 1 September 2006.
Furthermore, optimisation of the mutual recognition procedure and the decentralised procedure will be considered.
In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
Coordination groups for mutual-recognition and decentralised procedures human and veterinary products.
The CHMP also endorsed the changes to the product information for the medicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.
Furthermore, the use of the mutual recogntion and decentralised procedures for homeopathic medicinal products, including coordination thereof, will be discussed.
Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
The mutual recognition or decentralised procedure is the second European Community licensing system that is being established in Europe with co-operation between the Member States.
Diovan has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures- Human CMDh.
The matter was referred 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.
Tritace has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures- Human CMDh.
The decentralised procedure(or mutual recognition procedure) applies to the majority of conventional medicinal products and is based upon the principle of mutual recognition of national authorisations.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
One point was not mentioned in the debate at all, although I believe it to be very important:the Commission has proposed that prescriptions would also be required for medicinal products under the decentralised procedure.
The year 2006 is the first full year of operation of the Coordination Groups for Mutual-Recognition and Decentralised Procedures(CMDs) established by the new Community legislation.
The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures- Veterinary(CMD(v)) failed to reach an agreement for Equibactin vet.
The authorisation procedure is to retain the option of choice between the centralised and decentralised procedures, which has existed since 1995.
Directive 93/39 established, with effect from 1 January 1995, a decentralised procedure for mutual recognition of national marketing authorisations, together with binding arbitration by the Community in the event of disagreement between Member States see Article 4, second paragraph, subparagraph 11, Article 7(2) and 7(a) of Directive 65/65 and Articles 8 to 15c of Directive 75/319.
Some Members will say that the centralised procedure is costly for SMEs, but in the case of enlargement,the cost of 25 applications for market authorisation using the decentralised procedure will be much higher.
A marketing authorization application was submitted by the Applicant ProStrakan Ltd through the Decentralised Procedure for Rapinyl, a sublingual tablet containing 50, 100, 200, 300, 400, 600 or 800 µg fentanyl, as citrate.
Germany could not agree to the granting a marketing authorisation andthe matter was referred 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.
Taking part in the work on the creation of a database on jobs andlearning opportunities, in the context of decentralised procedures and taking full advantage of existing struaures and mechanisms such as the European Employment Services(EURES);
Denmark could not agree with the granting of the marketing authorisation andthe matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v) and subsequently the Committee for Medicinal Products for Veterinary Use CVMP.
The protection period agreed in the current compromise, of eight years, plus two, plusone, for the centralised and the decentralised procedure, ensures, firstly, that there is an incentive to carry out research, and secondly, that the further development of proven active substances is rewarded.
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 any 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.
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.