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European Medicines Agency’S Document Library

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“From Vision to Reality” The European Medicines Agency’s Road map to 2015 sets out the Agency’s vision, elaborates on the main drivers for progress and change that will impact on it, and explores the main initiatives to be undertaken to successfully meet the challenges it will face. It encompasses the Agency’s strategy for both medicines for human and veterinary use in line European public assessment report A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the European Medicines Agency website. European public assessment reports include the product information. Abbreviated as EPAR. Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they

Website: European Public Assessment Reports

European Medicines Agency’s Priority Medicines Scheme at 2 Years: An ...

This document provides guidance on clinical development programmes intended to support the registration of new medicinal products for the treatment of diabetes mellitus. It also addresses the development of products This assessment report reviews the scientific literature data available human and veterinary for Melaleuca alternifolia essential oil, and from the WHO monograph, European Pharmacopoeia monograph, British Pharmaceutical Codex monograph, ESCOP monograph, PubMed, EMA library and the internet, as well as available information on products marketed in the European

Human Veterinary Regulatory and procedural guidance Product information This page lists the reference documents and guidelines on the quality of product information for centrally authorised human medicines, including

3.pdf The requirement for ALT testing which has been deleted from the Ph. Eur. Monograph “Human plasma for fractionation”: Annex VI “Plasma-derived medicinal products: Position paper on ALT testing (CPMP/BWP/385/99; corrigendum September 1999)” included the scientific rationale for the deletion of the requirement for ALT testing. It has been taken out of this The Agency does not evaluate all medicines currently in use in Europe. If you cannot find the medicine you need through this search, please visit the website of your national health authority.

This document provides advice and recommendations on how to evaluate the potential for drug-food and drug-drug interactions for medicinal products (including herbal medicinal products) and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling. Keywords: Interaction, metabolism, inhibition, induction, The European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU). EMA evaluates applications for marketing authorisation submitted via the centralised procedure, monitors the safety of medicines across their lifecycle and provides information to healthcare professionals and patients.

European public assessment report

  • Pharmacokinetic studies in man
  • European Medicines Agency
  • Community herbal monograph on Melissa officinalis L., folium

This medicine’s product information is available in all official EU languages. Select ‚available languages‘ to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC. The European Medicines Agency’s contribution to science, medicines and health Adopted by the Agency’s Management Board on 16 December 2010 An agency of the European Union The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.

The applicant AstraZeneca AB submitted on 5 June 2015 an application for Marketing Authorisation to the European Medicines Agency (EMA) for TAGRISSO, through the centralised procedure falling within the Article 3(1) and point 3 of Annex of Regulation (EC) No 726/2004. EU Common Standard for electronic product information of this project (ePI) is authorised, statutory product information for EU medicines (the summary of product characteristics [SmPC, intended for healthcare professionals], labelling [outer and inner packaging information] and package leaflet [PL, for patients / consumers]) in a semi-structured format created using the EU Common

EMA is the European Union’s decentralised agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union and Agency Community herbal the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The agency also plays a role in

Recognizing the importance of this disease, the approval of human medicines containing a new active substance for the treatment of diabetes in the EU was made compulsory by European legislation in 2005 via one single, centralized application procedure at the

The European Medicines Agency’s (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human medicines. This page includes the European Medicines mainly addresses studies 1 Agency’s scientific guidelines that are specifically relevant to the development of medicines for children. These documents help applicants prepare paediatric investigation plans and other development programmes in children, supporting authorisation in children.

European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use The approach of this project is to work with five European regulatory agencies, exploring the effectiveness of different tools and processes they use while the agency continues, in parallel, to carry out its regular work in its regular way with regard to centralised procedure medicinal products evaluation. The European Medicines Agency was established in 1995 to oversee the scientific evaluation and the safety monitoring of medicines in the European Union. The remit of this European agency is to ensure public and animal health in all member states as well as in the countries of the European Economic Area (Norway, Iceland and Liechtenstein).

This document provides guidance to industry on practical aspects of the implementation of the Agency’s policy on the publication of clinical data for medicinal products for human use. This medicine’s product information is available in all official and drug drug interactions EU languages. Select ‚available languages‘ to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA);

This document provides guidance on the pharmaceutical development of medicinal products for children between birth and 18 years of age. Keywords: Pharmaceutical development, quality, child, paediatric formulation, paediatric investigation plan (PIP) The product information of a medicine includes its summary of product characteristics, labelling and package leaflet. These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used.

Website: European Public Assessment Reports (EPARs) – European Sources OnlineWebsite: European Public Assessment Reports (EPARs) This document provides guidance to prospective applicants to the PRIME (PRIority MEdicines) scheme, including relevant templates. medicine includes The Committee for Medicinal Products for Human Use (CHMP) and Committee on Advanced Therapies (CAT) should use the assessment report templates and documents listed below for the assessment of any new application in the centralised procedure.

103 2. Scope 104 The scope of this guideline is to provide advice and recommendations on how to evaluate the potential 105 for drug-food and drug-drug interactions for medicinal products and herbal medicinal products and how 106 to translate results of these evaluations to satisfactory treatment recommendations in the labelling. 107 The guideline mainly addresses studies 1. Executive summary This report outlines an EMA multi-year programme which defines a Master Data Management (MDM)1 strategy for the use of medicinal product data specifically related to Substance, Product, Organisation and Referential (SPOR) data. MDM is a technology-enabled discipline in which business and IT work together to ensure the uniformity, accuracy, and

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.