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This guidance is for staff and managers working in adult social care settings (ASC). It gives information on multidrug-resistant organisms and principles on how to prevent the spread of these pathogens.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
List of substances recognised as medicinal by function.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Marburg virus is a filovirus which, along with Ebola virus, can cause a severe and often fatal viral haemorrhagic fever (VHF).
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
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