Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines

Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines

As of the 1st of April 2022, the post-importation testing exemption requests for Biological and Biosimilar medicines should be submitted as per the requirements of Guideline 2.04. For submission process, please refer to section 3.0 Post-Importation Testing Exemptions (PITE).

2022 Mar

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Version: 1
Date Updated: 24/03/2022
File Type: pdf
Category: Communication to industry
Unit: Biological Medicines, Inspectorate and good manufacturing practices