Description
Unlicensed Medicines – what are they?
Any medical substance without a marketing authorization (MA) is classed as an “unlicensed medicine.” Under regulation 46 of the Human Medicines Regulations 2012 (SI 2012/1916), all medicines must have a marketing authorization unless exempt. The fundamental nature of an unlicensed medicine means that they are not approved by the MHRA, who are responsible for the licensing of all medicines.
What’s inside the course?
The course includes subjects for investors and license holders, wholesaling and/or manufacturing, regulatory frameworks, GMP (Good Manufacturing Practice), clean room requirements, various required licenses, management and teamwork ethics, data handling and management, Risk Assessment (RA), Quality Assurance (QA), financing, procurement, customer service, Quality Management System (QMS) processes and procedures, Quality Control (QC), raw material handling, warehousing requirements, and packaging.
Common Goal
The overarching goal for the Unlicensed Medicines course is ultimately patient safety as well as product quality. Unlicensed Medicines are very often specialist items for individual patients and there are very strict requirements for it’s procurement, manufacturing, handling, and storage/transportation. The course aims to enhance and amplify your knowledge base, common sense and compliance awareness, to help you be better prepared for correct and compliant conduct in this field.
Who is it for?
The course is for everyone involved in the handling, storage and/or manufacture of Unlicensed Medicines. For further assistance, please visit our help and support page. General information can be found in the European GDP Guidelines (2013/C 343/01).
