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This document describes the major differences between v.1.4.1 of the EU Module 1 eCTD specification and the previous version (v1.4) to assist potential users of the system during implementation, including
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How to fill out eu module 1 specification
How to fill out EU Module 1 Specification
01
Begin with the cover page, including the name of the medicinal product and the applicant's details.
02
Complete the module summary to provide an overview of the content in Module 1.
03
Fill out the administrative information, including the registration number and details of the responsible person.
04
Include information regarding the manufacturing site, ensuring compliance with Good Manufacturing Practices (GMP).
05
Attach the product label and package leaflet as required, ensuring all necessary information is included.
06
Provide details on the marketing authorization holder and their contact information.
07
Submit a Declaration of Compliance, certifying adherence to EU regulations regarding the product.
08
Review all sections for completeness and accuracy before submission.
Who needs EU Module 1 Specification?
01
Pharmaceutical companies looking to market their medicinal products in the European Union.
02
Regulatory affairs professionals responsible for ensuring compliance with EU regulations.
03
Quality assurance teams that oversee documentation and submissions.
04
Healthcare stakeholders involved in the evaluation of new medicinal products.
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People Also Ask about
What is included in CTD module?
Purpose. The CTD prescribes: Terminology. Module 1: Administrative information and prescribing information for Australia. Module 2: Common technical document summaries. Module 3: Quality. Module 4: Safety (nonclinical study reports) Module 5: Efficacy (clinical study reports) Dossier documents matrix.
What is the content of CTD module 1?
Module1 is for administrative information and prescribing information, and should contain documents that are specific to each region; for example, application forms or the proposed label for use in the region.
What is the content of CTD Module 3?
Module 3 of CTD refers to quality part. It covers relevant chemical and pharmaceutical information about the QUALITY of medicinal product, its active substances and excipients (including data for biological/biotechnological products).
What is the structure of EU Module 1?
The EU Module 1 architecture is similar to that of modules 2 to 5 of the eCTD, comprising a directory structure and a backbone with leaves. The backbone must be a valid XML document ing to the EU Regional Document Type Definition (DTD). The backbone instance (the eu-regional.
What is node extension in eCTD?
Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the eCTD structure and should be displayed as such when the XML backbone is viewed.
What is the eCTD specification based on?
The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
What is the content of CTD tablet?
CTD 6.25MG contains Chlorthalidone which belongs to the group of medicines called Diuretics. It is used to manage hypertension (high blood pressure) and heart failure. It also reduces fluid accumulation (edema) from the body that is caused due to certain liver or kidney diseases.
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What is EU Module 1 Specification?
EU Module 1 Specification refers to the standardized format for submitting marketing authorization applications for medicinal products within the European Union, in accordance with the EU regulations.
Who is required to file EU Module 1 Specification?
Pharmaceutical companies and any organizations seeking to obtain marketing authorization for their medicinal products in the EU are required to file EU Module 1 Specification.
How to fill out EU Module 1 Specification?
To fill out the EU Module 1 Specification, applicants must provide detailed information about the medicinal product, including its name, composition, manufacturing process, labeling, and safety data. It must be completed according to the guidelines set out by the European Medicines Agency (EMA).
What is the purpose of EU Module 1 Specification?
The purpose of EU Module 1 Specification is to provide a structured and consistent framework for the submission of marketing authorization applications, ensuring that all necessary information is presented to regulatory authorities for evaluation.
What information must be reported on EU Module 1 Specification?
Information to be reported includes product details, applicant information, the pharmaceutical form, proposed indications, dosing information, summaries of clinical and non-clinical studies, safety evaluations, and proposed labeling.
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