The European Commission website offers the possibility to create a CD-ROM with the content of the rules governing medicinal products in the European Union, which can be used off-line with an integrated search engine. This is a legally binding act published by the European Commission in June 2012 that provides details on the operational aspects for the new legislation GVP modules refer to the Commission Implementing Regulation No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities. However, until the availability of the respective GVP modules, volume 9A remains the reference. Volume 9 – Pharmacovigilance: With the application of the new pharmacovigilance legislation as from July 2012, volume 9A is replaced by the good pharmacovigilance practice.Volumes 5 to 8 apply only to veterinary medicinal products.Volume 4 – Good manufacturing practices.renewal procedures, variation procedures, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package-leaflet requirements Volume 2C - Regulatory guidelines: related to procedural and regulatory requirements, e.g.Volume 2B - Presentation and content of the dossier: provides guidance for the compilation of dossiers for applications for marketing authorisation, and is applicable for the centralised procedure and national procedures, including mutual-recognition and decentralised procedures.Chapter 6 – Community marketing authorisation.Volume 2A - Procedures for marketing authorisation:.
Volume 1 – Pharmaceutical legislation, contains most of the relevant Directives, Regulations, decisions and communications. The rules governing medicinal products in the European Union concerning medicinal products for human use is published on the European Union website: Information about the hierarchy of the European Union texts can be found in annex I to Procedures for marketing authorisation“, The Rules governing Medicinal Products in the European Union, Volume 2A, Notice to Applicants, Chapter 1. To exercise the Union's competences, the institutions may adopt regulations, directives, decisions, recommendations and opinions. How may I help you? (exit USCIS to YouTube).The treaties on which the European Union and the European Communities are founded are available. To learn more about Emma and see examples of questions applicants are asking her, check out this short video: Hello, I'm Emma. To send your feedback or ask for technical support, please email us at Please do not send questions about your personal situation or case to this mailbox instead, check your case status online or call us at 80. Emma works on desktop and laptop computers and mobile devices.Įmma’s development team is continuously refining her knowledge base to improve your experience. Getting Emma’s help is easy: just click the “Need Help? Ask Emma” link in the upper right corner of the page or the “Need Help” icon on the bottom of some pages. (Currently, the sound feature is only available on our English website.) Chatting with Emma is Easy If you have the sound on, she’ll also talk to you. Below Emma’s answer, she might also offer information related to your question. Find information based on the questions and search terms you use.Įmma is fluent in both English and Spanish, and she will always type out her answers. Provide immediate responses to your questions about all of our services. She also knows a lot of common search terms. What Can Emma Do?Įmma answers questions based on your own words you don't need to know “government speak”. Inspired by her namesake, our Emma can help you find the immigration information you need. 
Emma is named for Emma Lazarus, who wrote the poem inscribed at the base of the Statue of Liberty about helping immigrants.
Meet “Emma,” a computer-generated virtual assistant who can answer your questions and even take you to the right spot on our website.
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