Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Applying for a Manufacturer or Wholesaler of Medicines Licence" which outlines how to apply for, update and cancel licences for the manufacture, import, and wholesale of human and veterinary medicines.
This guidance provides essential instructions for businesses looking to manufacture or distribute medicinal products within the UK. This guidance covers obtaining such licenses' requirements, procedures, and regulatory obligations.
There are different manufacturer’s licences available depending on whether you are manufacturing licensed, unlicensed or investigational medicinal products.
Manufacturer's Licence (MIA): Required for companies involved in the production, assembly, or packaging of licensed medicines.
Wholesale Dealer's Licence (WDA): Necessary for companies engaged in distributing medicines, including importing/exporting medicinal products.
Manufacturer's Licence for Investigational Medicinal Products (IMP MIA): Specific to organizations involved in producing medicines for clinical trials.
The guidance provides step-by-step instructions on how to apply for both types of licenses. Applicants must complete a detailed application form, submit supporting documents, and pay the required fees. Applications are submitted through the MHRA’s online portal.
Individuals or companies that sell or supply human medicines to anyone other than the patient must have a wholesale distribution licence.
The wholesale distribution licence allows you to:
sell, supply, offer for sale or supply pharmacy, prescription only, traditional herbal and GSL medicines wholesale
import unlicensed medicinal products from countries inside the EEA
export medicinal products to countries of EEA
Use the process licensing (PCL) portal to apply for a wholesale distribution licence. The application will be assessed by MHRA and should take 90 working days to process. Variations to licences should take 30 working days to process. This will be extended to 90 working days if the variation requires an inspection.
Standard variations include changes to:
the business process
the named persons
the site address
A standard variation may require an inspection and you may have to pay an inspection fee as well as the variation fee.
Before a licence is granted, an MHRA inspection of the manufacturing or wholesaling site is typically required. The inspection ensures compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.
The guidance also details the fee structure for applying for a licence and any subsequent variations, as well as the annual fees that must be paid to maintain the licence. For more detailed information on how to apply for a manufacturer's or wholesaler's licence, and the requirements involved, you can refer to the full guidance here.
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