Example: bankruptcy
Electronic product information for human medicines in the ...
Definitions of ‘ePI’ and ‘common electronic standard’ are intended to explain the meaning of these terms as they are used in this initiative. 1.1. ePI 4 In certain procedures, Annex II of the marketing authorisation ... including both centrally and nationally authorised medicines, will be created using a common electronic standard. The
Tags:
Information
Domain:
Source:
Link to this page:
Documents from same domain
Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
Guideline on good pharmacovigilance practices …
www.ema.europa.eu9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25
Guideline on good pharmacovigilance practices …
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November
Guideline on good pharmacovigilance practices …
www.ema.europa.euharmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product
European Medicines Agency
www.ema.europa.eu© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline
products1/traditional herbal medicinal products
www.ema.europa.euThere is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already
Q7 Q&A - good manufacturing practice for active ...
www.ema.europa.euICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37
Related documents
Florida Building Code Advanced Training: Residential ...
www.floridabuilding.orgnationally recognized testing agency or ... which it is intended. R4101.4 Approvals. R4101.4.3 Applicant responsibility. It shall be the responsibility of the applicant to provide such data, tests or other adequate proof that the device, material or product will satisfactorily
ENVIRONMENTAL PROTECTION AGENCY
www.epa.govDec 07, 2021 · This table is not intended to be exhaustive, but rather provides a guide for readers regarding ... (EISA). The statute sets forth annual, nationally applicable volume targets for each of the four categories of renewable fuel. It also directs EPA to modify or establish volume targets in certain circumstances. EPA must then translate the volume ...
Nationally Determined Contribution (NDC)
www4.unfccc.intfollowing the country’s Intended Nationally Determined Contribution (INDC) to the objectives of the Paris Agreement submitted to the UNFCCC on September 30th, 2015, and ratified by the Government on September 7th, 2016. As per Paris Agreement Article 4, the 2020 NDC update builds upon the 2015 submission with a view