How to obtain a manufacturer''s import licence

If you are importing registered products from outside the European Economic Area (EEA) (the European Union plus Norway, Iceland and Liechtenstein), you will require a manufacturer's import licence (MIA).

To obtain a MIA, you will need to meet approved standards of Good Distribution Practice (GDP) and the relevant elements of Good Manufacturing Practice (GMP) in respect of batch release. You will need to submit a wholesale dealer's (import) licence application form (1199Kb) to the MHRA. The application form should be completed clearly and one copy submitted to the MHRA address on the application form. It should be signed by the applicant and the relevant page(s) should be signed by the nominated Qualified Person(s).

Please see MHRA Guidance Note 5: Notes for applicants and holders of a manufacturer's licence for assistance in completing the application form.

Granting of the licence will be subject to findings upon inspection.

A Site Master File (SMF) will be required for the manufacturing site in the third country (outside the EEA). This should be provided with your application for product registration or will be requested as your application is processed.

 Please see 'Guidance notes for industry on the preparation of a Site Master File for an overseas site subject to inspection by the UK regulatory authority' for guidance on what information should be included in the site master file for an overseas site and a worked example for reference purposes.

Qualified persons

Article 1(2) of Directive 2004/24/EC applies Articles 49-52 of Directive 2001/83/EC to the importation of (relevant products). All holders of a manufacturer's import 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 import licence.

› Information on the duties of QPs and transitional arrangements to help those already carrying out the duties of a QP to comply with the legal requirements.

Further information

For further information on the Traditional Herbal Medicines Registration Scheme, please see our 'Where to go for further advice' section.