Application For Registration European Mutual Recognition

Application for registration – European Mutual Recognition

Page 1 Application for registration – European Mutual Recognition For help or enquiries: Registration Department, Park House, 184-186 Kennington Park Road, London, SE11 4BU

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ICH and EU regulatory framework and the role of the ...

Alberto Ganan Jimenez, PhD –Quality of Medicines, European Medicines Agency (EMA) An agency of the European Union ICH and EU regulatory framework and the role of the European …

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STATEMENT OF THE CHAIR OF THE WORKING GROUP ON …

2 francophone African States1, eight Asian States2, and, in 2013, thirteen anglophone African States3.In its next report to the Human Rights Council, in 2016, the Working Group intends to report on the national legislation of countries in the Eastern European Group (EEG), as

  European

EU Module 1 eCTD Specification - Europa

Term Definition Applicant A pharmaceutical company or its agent that is submitting information in support of an application. Applicant’s Information Regulatory information submitted by an

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Guidance on the homeopathic medicinal products dossier

homeopathic medicinal product working group (hmpwg) guidance on module 3 of the homeopathic medicinal products dossier discussion in the hmpwg 2003- 2005 release for consultation december 2005 deadline for comments february 2006 discussion in the hmpwg june/november2006 adoption by the hmpwg november 2006 adoption by the hma november 2007 1

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HD 26/06 - PAVEMENT DESIGN - Standards for Highways

HD 26/06 Pavement Design Summary: This Standard provides the details of permitted materials and of thickness for the construction of pavements for new trunk roads.

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DRAFT OECD GUIDANCE DOCUMENT

4 No. 32, Guidance Notes for Analysis and Evaluation of Repeat- Dose Toxicity Studies (2000) No. 33, Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures (2001) No. 34, Guidance Document on the Development, Validation and Regulatory Acceptance of New and Updated Internationally

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eCTD Guidance Document - Europa

This guidance document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities

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Comparison of Drug Approval Process in United States & …

Comparison of Drug Approval Process in United States & Europe U. Nitin Kashyap, Vishal Gupta*, H. V. Raghunandan Pharmaceutical Quality Assurance Group, Department of Pharmaceutics,

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DMRB VOLUME 7 SECTION 3 - HD 30/08 - MAINTENANCE ...

may 2008 volume 7 section 3 part 3 Hd 30/08 1/2 chapter 1 introduction use in northern ireland 1.8 For use in Northern Ireland, this Standard will apply to those roads designated by the