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APPLICATION FOR THE REGISTRATION OF A FOOD BUSINESS ESTABLISHMENT (Regulation (EC) No. 852/2004 on the Hygiene of Foodstuffs, Article 6(2))This form should be completed by food business operators
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Annex 2 model application is a document used to request permission for the marketing authorization of a medicinal product in the European Union.
Any pharmaceutical company seeking marketing authorization for a medicinal product in the European Union is required to file annex 2 model application.
Annex 2 model application can be filled out electronically through the European Medicines Agency's website following the provided guidelines and instructions.
The purpose of annex 2 model application is to provide all necessary information about the medicinal product to the regulatory authorities for evaluation and approval for marketing authorization.
The annex 2 model application must include detailed information about the medicinal product's composition, manufacturing process, pre-clinical and clinical data, safety and efficacy profiles, and proposed labeling and packaging.
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