Whether you decide the Centralised, Decentralised or National route your choice in legal basis will remain the same. In the majority of circumstances only one legal basis will be appropriate whereby your product only fits into one category.
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Knowing the requirements and limitations to each option will help you determine which is the best approach or appropriate choice for you and your business. The table below outlines various differences in the dossier requirements between each legal basis. This use must also demonstrate that the active substance has a recognised efficacy and an acceptable level of safety. Another area that can present problems for companies who are inexperienced in the EU regulatory process is Module 1.
Module 1 is crucial to the successful validation of any procedure within Europe and requires time to compile and generate properly.
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