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Biological Medicines Communication To Industry

Document Number	Title	Categories	Date updated	Version	Units	File Type	Link	doc_categories_hfilter	doc_tags_hfilter
9.126	Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2	Communication to industry	2021 May	1	Biological Medicines Evaluation and Research		Download	communication-to-industry	biological-medicines-evaluation-and-research
	Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines	Communication to industry	2022 Mar	1	Biological Medicines Evaluation and Research, Inspectorate and good manufacturing practices	pdf	Download	communication-to-industry	biological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices
	Retention Fee Notification – 9 June 2022	Communication to industry	2022 Jun	1	Biological Medicines Evaluation and Research, General ECTD & human medicines, Inspectorate and good manufacturing practices, Medical Devices	pdf	Download	communication-to-industry	biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
	Communication on Medicines Registration Renewals Implementation Framework	Communication to industry	2022 Nov	2	Biological Medicines Evaluation and Research, General ECTD & human medicines, Quality, Veterinary medicines	pdf	Download	communication-to-industry	biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
	Renewals Frequently Asked Questions (FAQs)	Communication to industry, FAQ	2022 Nov	1	Biological Medicines Evaluation and Research, General ECTD & human medicines, Quality, Veterinary medicines	pdf	Download	communication-to-industry faq	biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines