ULM1

Define a marketing authorisation?

formerly known as a Product Licence (PL), is the regulatory approval of a specific medicinal product, thus enabling it to be marketed

Who gives out licenses?

Medicines and Healthcare products Regulatory Agency (MHRA)

What has a medicine with a MA been assessed for?

• has been assessed for efficacy, safety, and quality

• has been manufactured to appropriate quality standards

• when placed on the market is accompanied by appropriate product information and labelling

Where is MA and use defined?

Summary of Product Characteristics (SmPC)

What does the SmPC contain?

Name of the medicinal product

Qualitative and quantitative composition (active ingredient and strength)

Pharmaceutical form

Clinical particulars

Pharmacological properties

Pharmaceutical particulars

Other details relating to the market authorisation and text

What are the general steps of licensing?

• Eligibility request and pre-submission intention

• Submission of application

• Scientific evaluation

• Outcome and recommendation of scientific evaluation

• Licencing of product

What is the different methods of licensing?

• New drug

• Existing drug for different indication

• Existing drug with different dosing, route of admin

What are some issues with licensing in practice?

P meds have different licensing to their POM equivalent causing refusal of sales

Define Off label usage?

Use of a licenced medicine outside of its licence

different indication or an unlicensed dose or by different route of administration

What is off label recognised as standard practice for?

specific drugs (e.g. paediatrics)

Define unlicensed medicines?

is one which does not have a UK market authorisation

What must a unlicensed medicine do?

fulfil a patient need that cannot be fulfilled by a licenced product.

Specials or imported medicines would be on a named patient basis

Who can prescribed specials?

Not all prescribers

What is the MHRA hierarchy of risk basis of produce origin ignore?

Cost

What should a prescribe do when prescribing an off licensed medicine?

be satisfied that an alternative, licensed medicine would not meet the patient’s needs

be satisfied that such use would better serve the patient’s needs than an appropriately licensed alternative

be satisfied that there is a sufficient evidence base and/or experience of using the medicine to show its safety and efficacy

take responsibility for prescribing the medicine and for overseeing the patient’s care, including monitoring and follow-up

record the medicine prescribed and, where common practice is not being followed,

Why do we use unlicensed medicines?

To fulfil a clinical need that cannot be done with a licenced product

What groups may be in consideration for unlicensed medications?

Specific patient groups

Specific therapeutic areas

Patient centred factors

How long does a record of an unlicensed medication be kept for?

5 years

What must the unlicensed medication record contain?

the source from which and the date on which the person obtained the product

the person to whom and the date on which the sale or supply was made

the quantity of the sale or supply

the batch number of the batch of that product from which the sale or supply was made

details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware

What additional legal requirements do specials require?

The person must make the records available for inspection by the licensing authority on request.

The person must notify the licensing authority of any suspected adverse reaction

Where can extemporaneous preparation take place?

in a registered pharmacy under the supervision of a pharmacist