API registration is an MHRA requirement if you manufacture, import or distribute active substances and you are based in the UK. This may sound obvious but many companies who have been acting as API distributors for many years may not necessarily know that this is the case. The MHRA requirements for API registration can be found here: https://www.gov.uk/guidance/medicines-register-to-manufacture-import-or-distributor-active-substances
The requirements for registration are based on EC Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C:2015:095:FULL&from=ES
In order to qualify to register an API, a distributor must have a fully functioning and compliant Quality Management System along with appropriately trained designated persons to ensure the requirements of the QMS are adhered to.
Pharmacy Consulting Limited can not only provide API training (tailored specifically to your business model if required) but also support with the creation of a QMS and help with the API Registration process. Please contact us to discuss the many ways we can assist your organization:https://pharmacyconsulting.co.uk/contact/