University:
University of Wolverhampton
Course:
4PY019 | Pharmacy
Academic year:

2024
Views:

497

Pages:

2
Author:

Sara

Salbutamol Inhalers Contains salbutamol for asthma emergencies in schools HMR 2012 Human Medicines Regulations 2012 Prescriber Restrictions New prescribers in HMR 2012, e.g., Physiotherapist Independent Prescriber Auto-injectors Adrenaline auto-injectors for emergency use in schools Advertisement Promotes prescription, sale, or use of medicinal products SPC Sets boundaries for claims in adverts, varies for different types of products Regulations Controlled by MHRA, self-regulated, protect public health MHRA Medicines and Healthcare products Regulatory Agency, oversees advertising compliance Licence Holder Ultimately responsible for advertising compliance PAGB Administers OTC code of practice for pharmaceutical industry ASA Ensures adverts are legal, decent, and honest in all media Qualified Signatories Delegated responsibility for advertising compliance Complaints MHRA keeps copies for 7 years, companies for 3 years Public Health MHRA's key function is to protect public health through safe medicine use Vetting MHRA checks advertising compliance before publication Advertiser Responsibility Responsible for advert content and compliance Publisher Responsibility Has responsibility for published adverts 1/2 Breaches Offense for any person to breach advertising regulations MHRA Role Checks, monitors, and enforces advertising compliance Letter to Advertiser MHRA sends potential breach notifications to advertisers Regulation Enforcement MHRA enforces regulations when advertising does not comply Advertising Regulations Rules governing the promotion of medicines to the public Civil sanctions Non-criminal penalties imposed for breaching regulations Psychomotor effects Effects on mental processes and physical movement PIL Patient Information Leaflet Comparative claims Statements comparing a product to others in the market OTC Over-the-counter POM Prescription-only medicine HC professionals Healthcare professionals ADR Adverse Drug Reaction INN International Nonproprietary Name ABPI Association of the British Pharmaceutical Industry SPC indications Approved uses of a medicine as per its Summary of Product Characteristics EMC Electronic Medicines Compendium Homeopathic medicines Medicines based on the concept of treating like with like Blue Guide Guide to advertising and promoting medicines 2/2