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ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING Authorization HOLDER(S) IN THE MEMBER STATES 1 Member State AT Austria A —
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What is ema europa form?
EMA Europa form is a document that needs to be filed by pharmaceutical companies to seek marketing authorization for their medicinal products in the European Union.
Who is required to file ema europa form?
Pharmaceutical companies who wish to obtain marketing authorization for their medicinal products in the European Union are required to file the ema europa form.
How to fill out ema europa form?
The ema europa form can be filled out online on the European Medicines Agency (EMA) website. The form requires detailed information about the medicinal product, its efficacy, safety data, manufacturing information, and proposed labeling.
What is the purpose of ema europa form?
The purpose of the ema europa form is to provide the European Medicines Agency (EMA) with comprehensive data and information about a medicinal product in order to assess its quality, safety, and efficacy and grant or refuse marketing authorization.
What information must be reported on ema europa form?
The ema europa form requires reporting of information such as the product's name, active ingredients, formulation, indication, proposed labeling, clinical trial data, safety profile, manufacturing process, and quality control.
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