Newcastle Cellular Therapies Facility

MHRA Licences

Medicines and Healthcare products Regulatory Agency Licenses

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe for human use.

The MHRA is an executive agency of the Department of Health and an MHRA licence is required by law to manufacture medicinal products. The MHRA is the Competent Authority in the UK acting on behalf of the European Medicines Agency (EMA).

The Cellular Therapies Facility has two sites which are licensed to manufacture Advanced Therapy Medicinal Products (ATMPs) as MIA(IMP) - Investigational Medicinal Products and 'Specials' under the Newcastle upon Tyne Hospitals NHS Foundation Trust Licences. 

MIA(IMP) Licence

Licence ref: MIA(IMP) 17136.

When cellular or stem cell therapies are classified as investigational medicines involved in a clinical trial they must be manufactured under an MIA(IMP) Licence (Manufacturers Authorisation for Investigational Medicinal Products).

Specials Licence

Licence ref: MS 17136.

When there is a "special" need for a cellular therapy product for an individual patient and that patient is under the care of a specified clinician, the product is manufactured under a "Specials" licence. This does not require a clinical trial authorisation but will need approval under the local unlicensed medicines policy.