PL&E 4 - human medicines: regulation, licensing and advertising

what is the MHRA?

Medicines and Healthcare products Regulatory Agency

approving authority in UK

regulator of medicines, medical devices and blood components for transfusions

what must a medicinal product have for a person to sell/supply or offer to sell/supply?

a UK marketing authorisation (MA) - under Human Medicines Regulations 2012

what is the MHRA responsible for?

ensure medicines meet standards of safety, quality and efficacy

secure safe supply chain for medicines

promote international standardisation and harmonisation to assure the efficacy and safety of biological medicines

educate the public and healthcare professionals about the risk and benefits of medicines

enabling innovation and research that is beneficial to public health

how did MA laws change after BREXIT?

transitional arrangement: if a medicine had a CAP (centrally authorised product) from EMA, could still be used until 31/12/2022

on 01/01/2023, anything with a CAP must apply for a UK MA

what is a MA?

marketing authorisation

for a specific product

applicant must register with MHRA

submit an application to manufacturer with adequate evidence of safety and efficacy

MHRA review risk vs benefit

what is a conditional MA?

if a medicinal product meets an unmet need (where there is no treatment for a life-threatening disease or it offers a major therapeutic advantage) and there is a lack of data at that point but it is judged that that data will become available soon, the MA could provide them with an authorisation until they get the rest of the evidence they need to submit

what can the holder of a MA (conditional or not) do?

legally sell, supply, offer for sale or supply, or export the product

procure its sale, supply or exportation

procure its manufacture or assembly

what are falsified medicines?

fake medicines that are designed to mimic real medicines

false representation of its identity, source or history

what are a medicine’s summary product characteristics (SPCs)?

description of a medicinal product’s properties and conditions associated with its use

information on sale and effective use for healthcare professionals

what does a MA application include?

pharmaceutical form of the product

composition, physical characteristics and medicinal use

method of manufacture and assembly

quality control procedures

containers and labelling

reports of experimental and biological studies and of clinical trials

any adverse reactions

where the product is made abroad

what is a ML?

Manufacturer’s license - authorisation required from MHRA to produce, assemble or import medicinal products

need a ML before can apply for a MA

what is a WDA?

wholesale distribution authorisation

for individuals or companies that sell or supply human medicines to anyone other than the patient

issued by MHRA

what does a WDA allow?

the sale and supply (or offer) for P, POM, traditional herbal and GSL medicines wholesale

import unlicensed medicinal products from countries inside the EEA

export medicinal products to countries of EEA

what does a WDA specify/include details of?

premises from which distribution may be carried out

outlines the responsible person

detail of emergency plan for product recall and record keeping

what is pharmacovigilance?

monitoring medicine safety to detect, assess and prevent adverse effects once products are on the market

under what law do the MHRA have a responsibility for pharmacovigilance?

HMR 2012

what is the MHRA ‘yellow card scheme’?

collects and monitors information on suspected medicine/medical device safety concerns/incidents

voluntary reporting of suspected Adverse Drug Reactions (ADRs) by HCP and patients

‘early warning’ of safety issues

MHRA reviews products and if necessary takes action to minimise risk and maximise benefit for patients and public

what would you report on a ‘yellow card’?

all serious suspected ADRs

especially in children, over 65s, biological medicines and vaccines, those associated with delayed drug effects and interaction, and complementary remedies

what is the black triangle scheme?

for new medicines and vaccines

black triangle on package and SPC and BNF

MHRA maintains list, reviews ~5 years after marketing but no fixed limit (data dependent)

confirms the benefit/risk profile that was established for a medicine during clinical development

ensures that we identify previously unrecognised side effects as quickly as possible

what are the 4 categories of medicines recall?

1. national patient safety alert

2. class 2-3

3. class 4 - medicines notification

4. comply-led medicines recall/notification

what is a national patient safety alert?

issued when a defect in a medicine presents risk of death or disability

alerts issued via Central Alerting System or NPSA on MHRA website - immediate action

what are class 2-3 medicines recall?

class 2 - defect may cause mistreatment/harm but is not life-threatening or serious - action within 48 hours

class 3 - defect unlikely to cause harm, and recall carried out for other reasons (such as non-compliance with MA or specification) - action within 5 days

what is a class 4 medicines notification?

‘caution in use’ - issued when a drug has a minor defect, such as missing or outdated PILs or labelling errors

typically do not pose a direct threat to patient safety but require awareness

what is a company-led medicines recall?

issued where the licence holder is able to identify the affected customers, therefore it is not necessary to issue an alert to the entire NHS/healthcare system (as the issue is only relevant to a small number of recipients)

what are counterfeit medicines?

medicines that do not comply with intellectual-property rights or that infringe trademark law

what defines ‘advertising’?

anything designed to promote the prescription, supply, sale or use of a medicinal product

what are the advertising laws surrounding CDs and POMs to the public?

it is prohibited to ensure patient safety, with the exception of approved vaccine campaigns

what are the general principles of advertising medicines?

No person can publish an advert for a medicinal product unless there is a MA, certificate of registration or traditional herbal registration in place

must comply with particulars stated in SPC

must encourage rational use of the product - objectively, without exaggerating properties

should not be misleading

what are the guidelines around hospitality whilst advertising a medicinal product?

must be given to healthcare professionals only (persons qualified to prescribe or supply)

must be reasonable to main objective of meetings held solely for scientific or professional purposes

no person may supply/promise gifts, pecuniary (financial) advantage or benefit in kind unless it is inexpensive and relevant to the practice or medicine or pharmacy