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This document discusses various business issues and suggested changes regarding the EU Module 1 version 1.2.1, including specifics on folder usage, country codes, discrepancies in guidance, and additional
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Open the NtA Interlinking Meeting – EU Module 1 v1.2.1 document.
02
Navigate to the 'Issue for Discussion' section.
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Clearly state the issue you want to discuss.
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Provide background information or context for the issue.
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Outline the potential impacts or implications of the issue.
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Include any relevant data or examples to support your points.
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Who needs Issue for Discussion in the NtA Interlinking Meeting – EU Module 1 v1.2.1?

01
Participants in the NtA Interlinking Meeting.
02
EU officials and policymakers involved in interlinking discussions.
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Stakeholders seeking to raise specific issues for collaborative discussion.
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Facilitators and organizers of the meeting for agenda planning.
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EMA's official working language is English.
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What is the EMA's Linguistic Review Process? The EMA's Linguistic Review is the translation and review process for all new and updated Product Information (PI) required post-opinion for all medicinal products authorized by the European Union (EU) Centralized Procedure (CP).
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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The Issue for Discussion in the NtA Interlinking Meeting – EU Module 1 v1.2.1 refers to specific topics or concerns that stakeholders need to address during the meeting to facilitate interlinking processes in the European Union context.
Entities involved in the interlinking processes, including government representatives, regulatory bodies, and stakeholders within the EU, are required to file Issues for Discussion for the meeting.
To fill out the Issue for Discussion in the NtA Interlinking Meeting – EU Module 1 v1.2.1, participants should provide a clear description of the issue, specify its relevance, and detail any necessary background information or context.
The purpose of the Issue for Discussion is to identify, clarify, and discuss relevant topics that affect the interlinking procedures, ensuring that all stakeholders have a platform to voice concerns and propose solutions.
The information that must be reported includes a detailed description of the issue, its implications for the interlinking process, potential impacts on stakeholders, and any proposed actions or recommendations.
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