Harmonised Technical Guidance

Module 1 - Administrative information application form

Harmonised Technical Guidance (see above). Which language should be used in the application form? English should be used for a centralised procedure. English should be used for a mutual recognition or decentralised procedure.

  Form, Information, Applications, Guidance, Technical, Administrative, Module, Harmonised, Harmonised technical guidance, Module 1 administrative information application form

ICH HARMONISED TRIPARTITE GUIDELINE

process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S.2.2 – 3.2.S.2.6 (ICH M4Q). It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities. In

  Guidance, Technical, Harmonised

Harmonised Technical Guidance for Non-eCTD electronic ...

Technical NeeS Guidance v4.0 Page 1 of 19. Guidance for Industry on Providing Regulatory Information in Electronic Format . Harmonised Technical Guidance for . Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU . Version 4.0 October 2013

  Guidance, Technical, Harmonised, Harmonised technical guidance

EN 301 893 - V2.1.1 - 5 GHz RLAN; Harmonised Standard ...

ETSI EN 301 893 V2.1.1 (2017-05) 5 GHz RLAN; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU HARMONISED EUROPEAN STANDARD

  Harmonised

ICH HARMONISED TRIPARTITE GUIDELINE

ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH TABLE OF CONTENTS 1.

  Harmonised

Special Condition for small-category VTOL aircraft

The special condition has been established to prescribe the technical specifications for the type certification of a person-carrying vertical take-off and landing (VTOL) heavier-than-air aircraft in the small category, with lift/thrust units used to generate powered lift and control.

  Technical

ICH guideline Q9 (R1) on quality risk management

ICH Q9(R1) Guideline 2 33 scenarios, so that appropriate risk control can be decided upon during technology transfer, for 34 use during the commercial manufacturing phase. In this context, knowledge is used to make 35 informed risk-based decisions, trigger re-evaluations and stimulate continual improvements. 36 Effective and proactive quality risk management can facilitate …