Import license investigational medicinal products

In order for FDA to make the determination that export is not contrary to the public health and safety, manufacturers are required to submit with their export requests basic data regarding the safety of the device. There are two circumstances in which FDA does not recommend the submission of safety data with an export request:. To determine whether exportation of the device has approval of the country to which it is intended for export, a letter from the foreign country approving importation is required.

If the manufacturer is exporting to a country within the European Economic Area EEA a device that has been awarded the "CE mark," FDA will accept documentation of the "CE mark" in lieu of a letter from the foreign government approving importation. To obtain FDA's approval to export investigational devices to these countries, a request that includes the following information must be submitted to FDA:. The requester should flag the request "Export Request" and send it, along with any questions concerning the export of medical devices to:.

If the device is regulated by CBER, please contact them for further assistance at either or Industry. Biologics fda. This should reduce entry and processing time.

Affirmations of Compliance AoC will be required. Currently, AoCs are not required as entry reviewers manually verify this information anyway. Automatic prompting for this information in ACE should help prevent the most common entry error found when transmitting data to the FDA : submission of incorrect AoC information. Using DUNS numbers for Manufacturer, Shipper, Importer, and Delivered To Party will save entry time and help avoid the second most common entry error: submission of incorrect manufacturer information.

Note that the manufacturer refers to the manufacturing facility not the corporate office. Importing investigational medicinal products for use in clinical trials. Sponsors of UK clinical trials that import investigational medicinal products IMPs into Great Britain from outside the UK will need to review their existing supply chains. The purpose of this guidance is to describe the principles for the management and oversight of the import of IMPs to Great Britain from listed countries.

There is a one-year transition period from 1 January For further information, please email our Customer Services Centre at info mhra. Alternatively, contact your Trade Association by emailing:.

New guidance on authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries. Check what you need to do. UK, remember your settings and improve government services.

We also use cookies set by other sites to help us deliver content from their services. You can change your cookie settings at any time. Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.

MHRA aim to process all applications within 90 working days. If the human medicine you want to import contains a controlled substance having or using it is controlled by law you must contact the Home Office. How much you pay depends on the type of application, the number of sites, and your total turnover in licensed human medicines. Apply for a wholesaler licence. Apply for a manufacturer licence. You need to have an MA licence before you can sell a human medicine.

There are many types of MA licence so the process you need to follow depends on the type of MA licence you need. Apply for an MA licence. You may only obtain an introduced medicine from a person authorised in the country other than an approved country for import or if you are in Northern Ireland in the non-EEA country to supply medicinal products by wholesale distribution.

You can only export an introduced product to a person authorised in the country other than an approved country for import or if you are in Northern Ireland the non-EEA country to receive medicinal products for wholesale distribution or supply to the public. An introduced medicinal product will not have an MA for the UK or a country on an approved country for import list. You must send a completed notification of intent form to MHRA. Each entry must have the unique reference number you have given it and each unlicensed human medicine must be given a product code.