To manufacture, assemble or import medicinal products for human use, you need a Manufacturer’s Licence (MIA) issued by the Medicines and Healthcare Products Regulatory Agency (MHRA). There are different manufacturer licences available depending on whether you are manufacturing licensed, unlicensed or investigational medicinal products:
Manufacturer/importer licence (MIA):
- Manufacture and/or assemble licensed medicinal products
- Import from outside the EEA and export to outside the EEA
- Batch certification
Manufacturer ‘specials’ licence (MS):
- Manufacture unlicensed medicines ‘specials’
- Import unlicensed medicinal products from outside the EEA
Manufacturer licence for investigational medicinal products (MIA(IMP)):
- Manufacture investigational medicinal products for use in clinical trials
This Guidance Note has been published to assist applicants and holders of a Manufacturer’s Licence (MIA) or Manufacturer’s ‘Specials’ Licence (MS).
What personnel are required to obtain a Manufacturer’s Licence?
- The holder of a Manufacturer’s Licence must appoint at least one Qualified Person (QP), to be named on the licence
- A suitably qualified Production Manager of Head of the Production Department
- A suitably qualified Quality Controller or Head of Quality Control independent of the Production Department (This person may not act as the Production Manager, but can be names as the QP)
How do I apply for an MIA?
An application form should be completed and emailed to the MHRA accompanied by the Site Master File (SMF) of the manufacturing site. The SMF should contain specific information about the production and/or control of the pharmaceutical operations to be carried out. Your application will be assessed by MHRA and should take 90 working days to process.
The MHRA will only issue a Manufacturer’s Licence when it is satisfied, following an inspection of the site, that the information contained in the application is accurate and in compliance with the requirements of the legislation. All sites named on a Manufacturer’s Licence are subject to regular inspections. Each site is inspected every 2-3 years depending on the nature and scale of operation.
What are the fees?
Full application: £3143
Standard inspection: £2655 (per site)
Annual service fee: £468
There are also fees for variations (standard and administrative).
This blog gives you top line information on Manufacturer’s Licences however, if it is a Wholesaler Dealer’s Licence that you need, look out for my next blog.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.