Version 1.4.1 November 2011 - Europa

This document describes only the region-specific information that is common to all submissions in the different Member States. However, at the same time the EU Module 1 Specification allows for

  2011, November, 1 november 2011

eAF Release notes - esubmission.ema.europa.eu

eAF Release notes EMA/94046/2018 Page 7/65 Version 1.22.0.1 (Release Date: 16/02/2018) Version content Functionality / use case Comments

  Comments

Guideline on the specifications for provision of an ...

Guideline on specification for veterinary e-submissions Page 1 of 19 ... Version 2.45 December 20165 . Guideline on the specifications for provision of an electronic submission (e-submission) for a veterinary medicinal product. Adoption by Veterinary Harmonisation Group (version 2.45) December 20165 ... application form may accompany or follow ...

  Form, Guidelines, Specification

Harmonised Technical Guidance for Using of …

Page 4 | 73 Version 1.0 – July 2015 1.4. This application is submitted in accordance with the following article in Directive 2001/83/EC as amended..... 26

  Using, Guidance, Technical, Harmonised, Harmonised technical guidance for using

EU Module 1 eCTD Specification - Europa

CR 20110614 1.4.3 17 December 2012 EFPIA EFPIA changes, added PDF 1.5, 1.6, edited file allowed formats, added common for CP, adjustments to agency codes

  Specification, Module, Ectd, Eu module 1 ectd specification

eCTD Guidance Document - Europa

Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Version: 2.0, August 2011 1 (46) Guidance for Industry on Providing Regulatory Information in Electronic Format

  Document, Guidance, Ectd, Ectd guidance document

Guideline on the specifications for provision of an ...

Guideline on specification for veterinary e-submissions Page 5 of 18 Zipped files should not be used when sending CDs or DVDs. Applicants should provide the electronic submission on the smallest number of media components

  Specification, Electronic, Submissions, Electronic submission

Harmonised Technical Guidance for Non-eCTD …

Regulatory information must be structured in accordance with the . Common Technical Document (CTD), which for paper submissions became mandatory in the European Union with effect from 1 July 2003.

  Union, European, Guidance, Technical, Harmonised, Harmonised technical guidance for non, In the european union

eCTD Guidance Document - Europa

Page 1 of 60 . Guidance for Industry on Providing Regulatory Information in Electronic Format . Harmonised Technical Guidance for . eCTD Submissions in the EU

  Document, Guidance, Ectd, Ectd guidance document

Annex 4 to the HMA eSubmission Roadmap: Replacement of …

common repositories and use of master data (SPOR). CESSP Phase 1 is the first project towards the implementation of the Common European Single ... Implementation roadmap The replacement will apply to all the application forms and will be deployed in a stepwise approach,

  Implementation, Common, Roadmap, Implementation roadmap

Digital input module DI 32x24VDC BA (6ES7521-1BL10 …

Table 2- 1 Version dependencies of the module functions Function Firmware version of the module Configuration software STEP 7 (TIA Portal) GSD file in STEP 7 (TIA Portal) V12 or higher, or STEP 7 V5.5 SP3 or higher Firmware update V1.0.0 or higher V13 or higher X ...

  Input, Module, Version, Digital, Version 1, Lb110, Digital input module di 32x24vdc ba, 32x24vdc, 6es7521 1bl10, 6es7521

EMPLOYABILITY SKILLS Semester 1 Module 1 English Literacy

EMPLOYABILITY SKILLS – Semester 1 Module 2 I.T. Literacy Reviewed and updated on: 01st November 2019 Version 1.0 NIMI Question Bank Page 1 of 4 1 1 Byte = _____ A 2 bits B 4 bits C 8 bits D 16 bits Ans : C 2 A computer system consists of _____ A software and program B hardware and software C mouse and keyboard D circuit diagram Ans : B

  Module, Version, Version 1, Module 1, 1 module 1

HM-10 DataSheet - Cornell University

7.3.1 If Module is in sleep mode Module will wake up immediately, if AT+NOTI value is “1”, module will send “OK+WAKE” string through UART. 7.3.2 If Module has already connected to remote device Module will disconnect from remote device.

  Module

Features of the FlexTimer Module - NXP

Features of the FlexTimer Module 1. Introduction The application note introduces multiple features of the FlexTimer Module (FTM) and provides corresponding code for each feature, along with a waveform or a snapshot of the oscilloscope. While FTM is used in both the Kinetis and Vybrid families, this application note focuses on Kinetis only.

  Feature, Module, Features of the flextimer module, Flextimer, Features of the flextimer module 1

Guideline on good pharmacovigilance practices (GVP)

Revised draft Revision 1 adopted by Executive Director as final . 9 October 2017 Date for coming into effect of Revision 1* 22 November 2017** ** Note: The requirement for marketing authorisation holders to monitor EudraVigilance data (Sections IX.C.1.1. and IX.C.3.) and inform the Agency and national competent authorities of validated signals