Examples of using Decentralised procedure in English and their translations into Slovak
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Medicine
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Programming
A decentralised procedure.
Mutual recognition procedure and decentralised procedure.
The decentralised procedure.
Chapter 4 Mutual recognition and decentralised procedure".
The Decentralised Procedure UK/ H/ 0892/ 01/ DC started on 12 April 2006.
The mutual recognition procedure and the decentralised procedure.
The Decentralised Procedure, SE/ H/ 575/ 07/ DC, started on 1 September 2006.
The original Article 6 setting up a decentralised procedure is deleted.
Decentralised procedure subject to an Article 33 Referral(CD 17 April 2008).
In 2014 the Parliament adopted a report3 expressing some opposition to the decentralised procedure.
The decentralised procedure should be replaced by a centralised procedure at EU level.
Hexal AG submittedSanohex to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
It has therefore proposed that the decentralised procedure be integrated into the centralised procedure. .
Hexal AG submittedSabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
The decentralised procedure applies in cases where a medicine has not received a marketing authorisation in any Member State.
Paragraphs 1 and 2 shall not apply to veterinary medicinal products thathave been authorised through a mutual recognition or decentralised procedure before the date of the application of this Regulation.
In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
A marketing authorization applicationwas 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.
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 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.
For all types of applications submitted in accordance with this Regulation, the decentralised procedure or the procedure for mutual recognition, the formats made available by the Agency shall be used.
In the new proposal, the Commission is abolishing the decentralised procedure, which was criticised for imposing a heavy administrative burden and promoting a degree of fragmentation of the internal market.
Inc., the world leader in generic injectable pharmaceuticals,today announced the completion of decentralised procedure(DCP) for generic docetaxel, and expects to launch across most of Europe between now and the end of 2010.
After completion of a mutualrecognition procedure laid down in Article 48 or a decentralised procedure laid down in Article 46, the marketing authorisation holder may submit an application for a marketing authorisation for a veterinary medicinal product to additional Member States.
In response to question 1, the applicant provided a copy of theoriginal 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.
Failure of a Member State to fulfil obligations- Directive 2001/82/EC-Veterinary medicinal products- Decentralised procedure for the grant of marketing authorisation for a veterinary medicinal product in a number of Member States- Generic medicinal products similar to the reference medicinal products already authorised- Refusal to approve request by a Member State- Composition and form of the medicinal product.
The applicant provided a copy of theoriginal 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.