What is MHRA?

The MHRA (Medicines and Healthcare Products Regulatory Agency) was set up by the UK Government in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the governmental agency responsible for standards of safety, quality and performance.

Why is it Important?

The MHRA’s mission is to enhance and safeguard the health of the public in the UK by ensuring that medicines and medical devices work, and are acceptably safe.

The MHRA regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/ services that are derived from tissue engineering. Below are the definitions of key materials.

Medicine Regulations

Whether it’s a medicine you buy, or one prescribed for you as part of a course of treatment, it’s reassuring to know that all medicines available in the UK are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety, quality and efficacy.

What is a Medicine?

The law defines a medicine as something used in disease, whether it is used to prevent, treat or diagnose it, in anaesthesia, investigating conditions or interfering with the normal operation of the body. It does not include such things as contact lens fluids, food supplements and cosmetics.

Many factors are considered in deciding whether a product is actually a medicine such as what it contains, what it’s advertised or used for, the way it will be used, any particular targeting of the marketing information and what the promotional literature says. Claims that a product “supports” health or a healthy lifestyle is not usually considered as medicinal.

Control of medicines starts as soon as they are first discovered and tested in healthy volunteers, all the way through to when a company wants to change the conditions its products are approved for, such as changing the colour of the tablet or what it is used for.

Medical Devices Regulations

The Regulations implement the EC Medical Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state.

What is a Medical Device?

The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products - many thousands of items used each and every day by healthcare providers and patients.

Blood Regulations

The Blood Safety and Quality Regulations apply to blood establishments and to hospital blood banks. The 2006 Amendment Regulations introduce requirements for a quality system in blood establishments and hospital blood banks. They also extend traceability and record-keeping requirements to “facilities” which may receive blood and blood components (care homes, independent clinics, hospitals and other NHS facilities and services, manufacturers of medicines and medical devices and biomedical research institutes).

Who is it relevant to?

The MHRA is relevant to any organization supplying products to the UK healthcare market. Where can I find out more about the MHRA? Visit www.mhra.gov.uk for more information.

How can PRISYM ID help?

PRISYM Medica labeling software is purpose design labeling solution for Life Science organizations, specifically developed to help you meet current compliance requirements. PRISYM Medica is supplied as part of a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging as well as data integrity. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.