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How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
General announcements and latest decisions of the Certification Officer
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance for business and government departments.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
FDA trade union: trade union: annual returns, rules, statement to members, decisions and other related documents.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance for organisations when making decisions about the design and operation of enterprise IT services which handle OFFICIAL information.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
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