This section details how to obtain a manufacturer's licence.
To obtain a manufacturer's licence (ML), you will need to meet approved standards of Good Manufacturing Practice and submit a manufacturer's licence application form 
(1482Kb). The application form should be completed clearly and one copy submitted to the MHRA address on the form. It should be signed by the applicant and the relevant page(s) should be signed by the nominated Qualified Person(s) (QP) .
Please see MHRA Guidance Note 5, 'Notes for applicants and holders of a manufacturer's licence' for assistance in completing the application form.
You will also need to submit a Site Master File (SMF) to the MHRA. The SMF should contain specific and factual information about the production and control of manufacturing operations carried out.
The following guidance notes may help you when compiling a SMF:
- 'Guidance notes for industry on the preparation of a Site Master File'
- 'Guidance notes for industry on the preparation of a Site Master File for an overseas site subject to inspection by the UK regulatory authority'
Inspections
Granting of a licence will be subject to findings upon inspection by the MHRA. We carry out regular inspections of manufacturing sites both in the UK and non-European Union (EU) countries with which the EU does not have a Mutual Recognition Agreement.
All manufacturing sites named on the manufacturer's licence are subject to regular inspections. Each site is inspected approximately every two years depending on the nature and scale of the operation.
These inspections allow us to ensure that licence holders are complying with the conditions of their licence, with the provisions of the Medicines Act 1968, with Good Manufacturing Practice and with the conditions of the product registration.
Please see MHRA Guidance Note 5, 'Notes for applicants and holders of a manufacturer's licence' for further guidance.
Qualified persons
Article 1(2) of Directive 2004/24/EC applies Articles 49-52 of Directive 2001/83/EC to the manufacture of (relevant products). All holders of a manufacturer's licence for relevant products are required to have available the services of a Qualified Person (QP). The QP must be a resident in the UK and must be named on the manufacturer's licence. A QP does not have to be an employee of the registration holder but he or she must be accessible to them.
Further information
For further information on the Traditional Herbal Medicines Registration Scheme, please see our 'Where to go for further advice' section.
