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CHA SERVICESWRITTEN CONFIRMATION FOR EXPORT TO EU
A Written Confirmation is an official document issued by a competent authority confirming that the quality of an API produced in a third country meets the standards of the importing country. The Permiso team will provide comprehensive assistance, starting from the project’s paperwork through its successful completion.
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Any manufacturer desiring to export active substance to European Union for medicinal products for human use has to apply for a written confirmation from CDSCO. A written confirmation is equivalent to the GMP (Good Manufacturing Practice) issued as per WHO – GMP guidelines.
A Written Confirmation (WC) Certificate is issued to an organisation that wishes to export an Active Pharmaceutical Ingredient to an importing country, most notably the European Union. The applicant shall submit all the documents as per checklist. The Written Confirmation, unless it is sooner suspended or cancelled, shall be valid for a period of three years. The manufacturer is required to follow the guidance document for issue of Written Confirmation as issued by CDSCO .
Procedure for Obtaining a Written Confirmation in India:
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Obtaining Login credentials: To obtain a Written Confirmation, the applicant must first register in an online portal and create a Login ID and Password
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Documentation: The applicant must produce documents and upload them online accordingly. All documents must be submitted as per the checklist.
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Inspection: Following the submission of documentation, the Drug Inspector visits the manufacturing premises to authenticate the location and verify the documents.
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Issue of Written Confirmation: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant the written confirmation.
Pre - Requisites / Documents required for Written Confirmation :
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Application from Manufacturer
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Site Master File (as per WHO TRS 961, Annexure 14)
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An Authorisation Letter by the Director / Partner / Secretary of the company
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Legal undertaking
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GMP Certificate if any
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Manufacturing License
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List of Approved API’s
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List of API applied for issuance of Written Confirmation
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List of SOPs and STPs
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Stability Studies of 3 Batches
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List of Equipment and Instruments
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Manufacturing Plan Layout
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Validation Master Plan
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Process Validation for 3 batches of each product
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Annual Product Review for last 3 years
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Export data for lats 3 years
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Analytical Method Validation
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Market Complaint Review
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Data of Impurity Profiling
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NSQ Reports
Surveillance inspections/Inspection for Cause/Inspection after Major Changes may be conducted as directed by the “Competent Authority(DCG(I)”. The application shall be prescreened at the time of receipt of the application for its completeness of documents. Non compliances if any will be communicated to the firm accordingly.
Obtaining a Written Confirmation (WC) for export can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the certificate. We reduce the likelihood of application rejection and ensure that Written Confirmation Certificate is issued quickly and without complications.
You can apply for a Fresh Written Confirmation / Renewal of Written Confirmation / Amendment in Written Confirmation / Change in Constitution through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com
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WRITTEN CONFIRMATION Registration Procedure
