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Product-information requirements

The European Medicines Agency (EMA) provides?guidance and templates to provide marketing authorisation applicants?with practical advice on how to draw up the product information for human medicines, which includes the summary of product characteristics, labelling and package leaflet. EMA's guidance explains the content that should be included in these documents, as well as standard headings and the most commonly used standard statements and terms in all official European Union (EU) languages plus Icelandic and Norwegian, and defines the format and layout for the product information.

EMA's guidance is?without prejudice to:

  • any final positions from the Agency, the Committee for Medicinal Products for Human Use (CHMP) or European institutions relating to the contents of the documents;
  • the binding nature of the relevant legislation;
  • any legal interpretations given by the European Commission or the Court of Justice of the European Union.

Guidance for developers of COVID-19 vaccines

Guidance is available on flexibilities to help developers of COVID-19 vaccines prepare and roll out packaging and labelling for their vaccines quickly. It includes practical advice on exemptions to some requirements that are possible, while keeping in line with regulatory requirements:

The guidance aims to facilitate the large-scale and rapid deployment of COVID-19 vaccines within the?EU.

It provides details further to the European Commission's?memorandum of Understanding (MoU) with Member States on regulatory flexibility for COVID-19 vaccines.

Guidance for developers of COVID-19 treatments

Guidance is available on flexibilities to help developers of COVID-19 treatments prepare and roll out?packaging and?labelling?for their treatments quickly:

    Electronic product information initiative

    In 2021, EMA,?national competent authorities?and the European Commission started an electronic?product information?(ePI)?set-up project.

    It aims at developing a common?electronic standard?for ePI, carrying out a proof-of-concept exercise for implementing the standard and creating a roadmap for implementation across the EU.

    EMA?will publish?progress updates and details of stakeholder consultations with patients, healthcare professionals, academia?and pharmaceutical industry.

    In January 2020, EMA, the Heads of Medicines Agencies (HMA) and the European Commission published key principles to guide the development and use of ePI?for human medicines in the EU:

    The development of electronic tools to improve access of patients and healthcare professionals to information on medicines?is one of the key recommendations?in a 2017 report from the European Commission and?EMA's?subsequent action plan to improve the product information for EU medicines:

    Mobile scanning and other technologies

    Applicants and marketing authorisation holders can request the inclusion of?mobile scanning and other technologies (including quick response (QR) codes)?in the context of an evaluation procedure, including:

    • as part of the initial marketing-authorisation application;
    • after the medicine is authorised via Article 61(3) with the rapporteur's involvement;
    • as part of other procedures affecting annexes.

    They should request inclusion of these technologies?by submitting the following form,?along with all relevant information within module 1.3.1 of the dossier:

    For guidance on?submission requirements, general principles of acceptability and assessment of mobile scanning and other technology requests, see:

    This guidance replaces EMA's guidance document on?‘Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal products.’

    A list of PDF icon national contact points has been set up for the review of national versions of mobile scanning and other technologies approved through the centralised procedure.

    Information on doping

    There is no direct legal requirement to include information on doping in sport in the product information of centrally authorised medicines. The Agency advises applicants not to include statements on doping.

    However, the Agency acknowledges the public-health interest in accessing up-to-date information on substances that can be used in doping. This information is available on the website of the World Anti-Doping Agency (WADA), an independent international organisation created to promote, coordinate and monitor the fight against doping in sport in all its forms:

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