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article 57: Substances to be included in Annex XIV The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58 :

As of July 2018, the European Medicines Agency (EMA) publishes data from the Article 57 database on all medicines authorised in the European Economic Area (EEA). Marketing authorisation holders must submit and maintain this information in accordance with European Union (EU) legislation. Data submission on authorised medicines (Article 57) All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date. Measures for Article 57 Data Qualit y Assurance EMA/465609/2015 Page 3/29 1. Introduction The Article 57 database delivers structured and quality assured information on medicinal products authorised in the EU that can support EU ter minologies of products, substances, and organisations Regulatory information on Article 57 database 09.02.2016 As of 1 February 2016 marketing authorisation holders of medicinal products for human use are no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF). (f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of Electronic submission of Article 57(2) data EMA/159776/2013 Page 4/75 3.16.2. Population of presentation name elements for medicinal products with multiple trade PSUR Repository und Artikel 57-Datenbank: Hinweise zu Verpflichtungen der pharmazeutischen Unternehmer.

Jun 5, 2020 All 57 of the members of the Buffalo Police Department's Emergency Response Team resigned Friday from the unit which responds to riots and Create citation alert. 0004-637X/779/1/57 However, such a jump in the EM is not clearly seen in the south bubble data. While it is unclear whether the NPS 5 days ago Gordon and colleagues present an analysis of pooled data from four studies forecasting the outcomes of large-scale replication projects in the Data related to baseline medication exposure including calcium or vitamin D White, 5772 (51), 31 317 (55), 121 126 (57), 283 414 (57), 216 303 (56), 89 985 Jolliffe and Prydz (2016) address this issue of comparability by estimating the national poverty lines that are implied by poverty rates. The set of national poverty DECODE provides tools that put individuals in control of whether they keep their personal data private or share it for the public good. Mendeley Data Repository is free-to-use and open access. It enables you to deposit any research data (including raw and processed data, video, code, software, 1 This Act applies to the processing of data pertaining to natural persons and legal 57 Second sentence according to No I of the FA of 24 March 2006, in force Sep 17, 2020 It provides current data on house prices as well as metrics used to assess valuation in housing markets, such as house price-to-rent and Aug 19, 2016 98 personal data points that Facebook uses to target ads to you 57. Users who administer a Facebook page 58.

Förutom den centrala dokumentationen nedan bör en datahanteringsplan även innehålla Hur säkerställs lagring och säkerhetskopiering av data och metadata under forskningsprocessen? Artikel |. Publicerad 25 januari 2021. European Open Science Cloud, EOSC, är tänkt att bli en öppen Vetenskapsrådet, FE 57

Data submission on authorised medicines (Article 57) All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date. The Article 57 database delivers structured and quality assured information on medicinal products authorised in the EU that can support EU ter minologies of products, substances, and organisations used to power pharmacovigilance and regulatory systems in the EU. Article 57 product data The European Medicines Agency (EMA) - publishes data from the Article 57 database on all medicines authorised in the European Economic Area (EEA) such as product name, active substance, route of administration, country of authorisation, name of the marketing authorisation holder (company), country of location of the pharmacovigilance system master file and marketing Article 57 database. Subject to the applicable rules, it is not expected that marketing authorisation holders submit a specific (final) variation to switch to the new system. For further questions on the Article 57 database and the business process for change management of EU marketing authorisations, marketing authorisation holders may refer The European Medicines Agency (EMA) offers training on how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as Article 57 database.

RSK-databasen, allt om VVS-produkter Här hittar du enkelt information om VVS-produkter, så som monteringsanvisningar, produktblad, typgodkännande och bilder m.m.

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Please log in or visit www.KAATSU.com to learn how you can become certified. The assumption that depressed patients who are assigned to placebo in antidepressant clinical trials are exposed to substantial morbidity and mortality is not based on research data. We assessed suicides, suicide attempts, and depressive symptom reduction in studies of 7 new antidepressants using th … Wikipedia (/ ˌ w ɪ k ɪ ˈ p iː d i ə / wik-ih-PEE-dee-ə or / ˌ w ɪ k i-/ wik-ee-) is a free, multilingual open-collaborative online encyclopedia created and maintained by a community of volunteer contributors using a wiki-based editing system.Wikipedia is the largest general reference work on the Internet, and one of the 15 most popular websites as ranked by Alexa; in 2021, it was Public data from Article 57 database As of July 2018, the European Medicines Agency (EMA) publishes data from the Article 57 database on all medicines authorised in the European Economic Area (EEA).
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Artikel 57. Afstand . Van het Uniemerk kan afstand worden gedaan voor alle of van een deel van de waren of diensten waarvoor het ingeschreven is.

New substances are regularly added to the Candidate List, usually twice a year. database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004.’ (9). The data fields in that detailed technical guidance take account of international harmonisation efforts.
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Art. 57 GW - Artikel 57 Grondwet - Artikel 57 1. Niemand kan lid van beide kamers zijn.2. Een lid van de Staten-Generaal kan niet tevens zijn minister, staatssecretaris, lid van de Raad van State, lid van de Algemene Rekenkamer, Nationale ombudsman of substituut-ombudsman, of lid van of procureur-generaal of advocaat-generaal bij de Hoge Raad.3.

Utan att det påverkar de andra uppgifter som föreskrivs i denna förordning ska varje tillsynsmyndighet på sitt territorium ansvara för följande: Substances fulfilling one or more of the criteria defined in REACH Article 57 can be identified as Substances of Very High Concern (SVHCs) and put on the Candidate List for authorisation. New substances are regularly added to the Candidate List, usually twice a year.

PSUR Repository und Artikel 57-Datenbank: Hinweise zu Verpflichtungen der pharmazeutischen Unternehmer. Das PSUR Repository ist eine zentrale Datenbank bei der Europäischen Arzneimittel-Agentur (EMA) zur Einreichung, Archivierung und Verwaltung sämtlicher periodischer Sicherheitsberichte (Periodic Safety Update Reports = PSURs) und den dazu gehörenden Prozessdokumenten (Assessment Reports

The information required for the SCIP database must already be communicated throughout the supply chain under REACH Article 33(1).

RSK-databasen, allt om VVS-produkter Här hittar du enkelt information om VVS-produkter, så som monteringsanvisningar, produktblad, typgodkännande och bilder m.m. database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004.’ (9). The data fields in that detailed technical guidance take account of international harmonisation efforts. The content of the data fields is kept identical with the U.S.-database ‘clinicaltrials.gov’, PSUR Repository und Artikel 57-Datenbank: Hinweise zu Verpflichtungen der pharmazeutischen Unternehmer. Das PSUR Repository ist eine zentrale Datenbank bei der Europäischen Arzneimittel-Agentur (EMA) zur Einreichung, Archivierung und Verwaltung sämtlicher periodischer Sicherheitsberichte (Periodic Safety Update Reports = PSURs) und den dazu gehörenden Prozessdokumenten (Assessment Reports New EudraVigilance website Announcement to EudraVigilance website users The public information on this website has been incorporated into the European Medicines Agency corporate website.