new applications for registration as Active Substance manufacturers, importers and distributors take 60 working days - if an inspection is required: 90 working days.variations where no inspection is required: 30 working days - variations where an inspection is required: 90 working days.new applications typically take 90 working days to process.The Heads of Medicines Agencies (HMA) PortalĪpply for new broker registrations and to vary existing broker registrations via Application forms for manufacturer licences: The portal should be used for wholesale distribution authorisations and active substance manufacturers, importers and distributors – new applications, variation applications and annual compliance reports (active substance manufacturers, importers or distributors only). The MHRA Process Licensing Portal is part of the government's Digital by Default agenda and is a web application which provides a secure environment and an easy to use platform which allows customers to submit new applications and variations to existing wholesale distribution authorisations electronically via certificates of Good Distribution Practice (GDP).certificates of Good Manufacturing Practice (GMP).active substance manufacturer, importer or distributor registrations.blood establishment authorisations (BEA).licences for the wholesale distribution/importation of medicinal products for veterinary use - WDA (V).licences for the wholesale distribution of medicinal products for human use, commonly abbreviated to WDA (H) (including those covering unlicensed medicines obtained from another EEA member state).manufacturer's licences for exempt advanced therapy medicinal products (MeAT).'specials' licences for the manufacture of unlicensed medicinal products for veterinary use, (ManSA).authorisations for the manufacture/importation of licensed medicinal products for veterinary use (ManA).authorisations for the manufacture/importation of investigational medicinal products for human use, commonly abbreviated to MIA(IMP).'specials' licences for the manufacture/importation of unlicensed medicinal products for human use, commonly abbreviated to MS.licences for the manufacture/importation of licensed medicinal products for human use, commonly abbreviated to MIA.It typically deals with the manufacture, assembly and wholesale distribution of medicinal products under UK and EU legislation, these licences are often called process licences and include: The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division.
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