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UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device

This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical devices.

This guidance provides an overview of the process including submitting or fast tracking an application, naming your medicine and paying fees. Before applying for a licence, you need to determine the type of licence you require.

This could be a national licence, European licence, or parallel import licence. All UK and Great Britain (England, Scotland and Wales) national applications should be submitted through the MHRA Submissions Portal.

Applications can be fast-tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine. Check out this guidance that elaborates on the steps and factors that need to be considered for Applying for a license to market a medicine in the UK.

Exporting drugs and medicines from the UK involves adherence to specific regulations and guidelines to ensure compliance with international standards. The guidance provides a detailed explanation of the special rules for exporting drugs and medicines.

You need permission to export:

Click this LINK to know what steps are required to get permission to export certain drugs and medicines.

Reclassification refers to the process of changing the legal classification of a medicine or medical device. It involves moving a product from one category to another, such as from a prescription-only medicine (POM) to a pharmacy medicine (P), or from a pharmacy medicine to a general sales list (GSL) medicine.

  • Prescription-Only Medicine (POM) - must be prescribed by a doctor or other authorised health professional and must be dispensed from a pharmacy or from another specifically licensed premises;

  • Pharmacy Medicines (P) - can be bought only from pharmacies and under a pharmacist’s supervision;

  • General Sales List Medicines (GSL) - may be purchased without the supervision of a pharmacist and are available in retail outlets, such as a newsagent, a supermarket, or a vending machine in a shop.

This guidance explains how to apply your medicine to a different classification.

If you are planning to conduct a clinical investigation, it is important to notify the MHRA and comply with the relevant regulations. This guidance will guide how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Applications are submitted electronically using the Integrated Research Application System (IRAS).


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