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Information on the Member States requirement for the ...
the Austrian competent authority has the option to require the nomination ... marketing surveillance studies on the market, the volume of sales or ... pharmacovigilance contact person at national level shall: • report to the QPPV (reporting in this context relat es to :
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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
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)
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 (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
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
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EUROPEAN COMMISSION DG Health and Consumers (SANCO ...
meddev.infomarket surveillance; ... The term "post-marketing surveillance" as referred to in Annexes 2, 4, 5 in AIMD has the ... National Competent Authorities outside Europe who are involved in the GHTF National Competent Authority Report (NCAR) exchange programme. These guidelines are relevant to INCIDENTs occurring within the Member States of the ...
Vigilance Reporting - BSI Group
www.bsigroup.comMust Report - Trends . If a significant increase or trend of events or incidents that are usually excluded from individual reporting . The manufacturer should have suitable systems in place for proactive scrutiny of trends in complaints and incidents occurring with their devices - MedDev 2.12.1 . Report to National Competent Authority
IMDRF terminologies for categorized Adverse Event ...
www.imdrf.orgboth pre and post market as described in section 5. Notably, the precise criteria for reporting adverse events are defined by each regulatory authority and are not subject to this guidance document. Reference is made to the relevant guidance documents of each jurisdiction and the GHTF document on Post Market Surveillance:
THE NATIONAL INTERNAL REVENUE CODE OF THE …
www.seatca.org(E) Authority of the Commissioner to Prescribe Real Property Values. - The Commissioner is hereby authorized to divide the Philippines into different zones or areas and shall, upon consultation with competent appraisers both from the private and public sectors, determine the fair market value of real properties located in each zone or area.
Clinical Evaluation Reports from the medical writer’s ...
journal.emwa.orgpost-market surveillance (PMS) information. Summary Although it is the first section to be read, the summary is the last to be written. The summary should give a succinct overview of the clinical condition and state of the art; brief details of the subject device and its indication; conclusions of the evaluation pre-clinical studies, pre-market