MHRA publishes consultation outcome for guidance on the licensing of biosimilar products
Consultation outcome of MHRA guidance on the licensing of biosimilar products can be found at below ...
Read more
Tag: MHRA
MHRA publishes Guidance for Responding to a GLP and GCP laboratory inspection report
Format provided by MHRA is not mandatory but is the MHRA inspectorate’s preferred method for providing ...
Read moreMHRA publishes Guidance on Types of application (legal basis)
The appropriate legal basis will depend the type of application you are making. The legal bases ...
Read more
MHRA publishes guidance Electronic Application Form (eAF) and Cover Letter
This tool is designed to help applicants determine the additional information required in the Cover Letters ...
Read moreMHRA publishes new form and fees for request for scientific advice
Updated form & fees for scientific advice an be found at below link. Form https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/973838/Scientific_Advice_request_form.docx Fees ...
Read more
MHRA issues link for Device Online Registration System in Guidance to Register medical devices to place on the market
MHRA, UK Added a link for existing customers to log into the Device Online Registration System ...
Read moreMHRA Publishes GPvP inspection reports under the Freedom of Information Act
Under the Freedom of Information Act, MHRA publishes GPvP inspection reports with critical and / or ...
Read more
MHRA pilots patient involvement in new applications
From today, when new applications for selected medicines (new active substances and new indications) are received, ...
Read more