Decentralised procedure
Found 11 free book(s)
Module 1 - Administrative information application form
www.ema.europa.euThe procedure number is the Mutual Recognition Procedure number allocated by the RMS. “First Use” means the first Mutual Recognition Procedure. All the concerned Member states should be indicated. “Repeat use” means a new use (“wave”) of the same mutual recognition or decentralised procedure made to include new concerned member ...
VOLUME 2A Procedures for marketing authorisation CHAPTER …
ec.europa.eudecentralised procedure (hereafter “the coordination group”). The applicant cannot stop this procedure by subsequently withdrawing the application in the referring Member State. If no agreement can be reached in this group the matter is referred for arbitration to the EMEA. Any matter dealt with by the coordination group in a
Practical user guide for electronic Application Forms (eAF ...
esubmission.ema.europa.euA Decentralised Procedure..... 56 1.1.4. A National Procedure ..... 57 1.2. Is this an application for a change to your existing marketing authorisation leading to an extension as referred to in Annex I of Regulation (EC) NO 1234/2008, or any national ...
VOLUME 2B Module 1.2: Administrative information ...
ec.europa.euA DECENTRALISED PROCEDURE (according to Article 28(3) of Directive 2001/83/EC ) Reference Member State: Procedure number: Concerned Member State(s) (specify): AT BE BG CY CZ DE DK EE EL ES FI FR HR HU IE IS IT LI LT …
EU CENTRALISED PROCEDURE Key steps and considerations …
www.topra.orgdecentralised procedure is possible as long as a suitable justification can be given that it would represent a significant therapeutic, scientific or technical innovation, or that its authorisation would be in the interest of patients at a community level. The CP assessment process
MRP & DCP step by steb instructions how to apply and how ...
www.ema.europa.euaccepted via the Decentralised Procedure, provided that the same Reference Member State is used. The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health Federal Institute for Drugs and Medical Devices DCP/MRP BAH- WiDi 22. 03. 2011 18
eCTD Guidance Document - Europa
esubmission.ema.europa.euProcedure A Community registration procedure for the authorisation of medicinal products in the European Community. There are 4 types of procedure that ope–rate within the EC Centralised, Decentralised, Mutual Recognition and National. Submission or Sequence A single set of information and/or electronic documents
Design and Analysis of a 1MW Grid- Connected Solar PV ...
media.africaportal.orgstandard procedure developed was validated in the design of a 1MW grid-connected solar ... Decentralised grid-connected PV applications include rooftop . PV generators, where the PV systems are mounted on rooftops of buildings and incorporated into the building’s integrated system (DGS, 2008). ...
Packaging ‘blue-box’ requirements and additional ...
www.hma.eumutual recognition, decentralised or centralised procedures . Additional information on labelling/package leaflet that may be required or permitted nationally in accordance with Articles 58 and 64 of Directive 2001/82/EC, as amended, is outlined below. Index
Decentralised Wastewater Treatment Systems (DEWATS) …
sswm.infoDecentralised Wastewater Treatment Systems (DEWATS) and Sanitation in Developing Countries. Decentralised Wastewater Treatment Systems (DEWATS) ... 6 CBS Programme – detailed procedure for implementation 100 6.1 First planning activities 100 6.2 The pilot project 103 6.3 Preparation phase 105
MAKING POLICY BETTER - The Institute for Government
www.instituteforgovernment.org.ukincreasingly inappropriate in a world of decentralised services and complex policy problems. In the face of these challenges, we need to give a more realistic account of what good policy making should look like – and then ensure the surrounding system increases its resilience to the inevitable pressures to depart from good practice.