
Procedural Guidance on Inclusion of Declared Interests in the Form


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People also ask
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What is the sunset clause in EMA?
A legal provision stating that the marketing authorisation of a medicine will cease to be valid if the medicine is not placed on the market within three years of the authorisation being granted or if the medicine is removed from the market for three consecutive years.
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What is the Centralised procedure guideline?
The centralised procedure is a European authorisation route resulting in a centrally authorised product with a single Marketing Authorisation. If a product has been authorised using the centralised procedure it has been assessed on an EU wide basis and approved by the European Commission.
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What is the EMA declaration of interests?
The provision of information on all potential conflicts of interests by an individual, including recent work activities, investments and family connections with the pharmaceutical industry. More information can be found under 'Handling competing interests'.
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What is EMA standard?
The EMA is a moving average that places a greater weight and significance on the most recent data points. Like all moving averages, this technical indicator is used to produce buy and sell signals based on crossovers and divergences from the historical average.
-
What are the EMA guidelines?
A document providing guidance on the scientific or regulatory aspects of the development of medicines and applications for marketing authorisation. Although guidelines are not legally binding, applicants need to provide justification for any deviations.
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What are EMEA guidelines?
Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives. HumanRegulatory and procedural guidanceScientific guidelines.
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What is the difference between the FDA and the EMA guidelines?
The FDA is responsible for regulating a wide range of products for human and animal use in the US, including medicines, medical devices, tobacco products, cosmetics and most foods. In contrast, the EMA governs only human and veterinary medicines and participates in the process of medical devices evaluation.
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What is the EMA policy?
The European Medicines Agency's (EMA) policies and procedures ensure that the Agency's long-term vision and goals are translated into concrete steps. They set the boundaries for all major decisions and actions taken by the Agency.
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