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ANNEX Application for Approval of a Standard Residency Program (SRP)(To be downloaded also on the website of the EC BHM www.ecbhm.org)Name of the Resident:Private address:Date of entry into the residency
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The Annex II application is for requesting approval for the manufacture or import of active substances intended for use in medicinal products for human use.
Any company manufacturing or importing active substances for use in human medicinal products is required to file an Annex II application.
The Annex II application can be filled out online on the official regulatory authority website by providing all the required information and documentation.
The purpose of the Annex II application is to ensure the quality, safety, and efficacy of active substances used in human medicinal products.
The Annex II application must include detailed information about the manufacturing process, control of impurities, stability data, and quality control methods.
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