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

2024
Views:

66

Pages:

2
Author:

Sara

Human Medicines Regulations 2012 Legislation outlining labelling requirements for dispensed and retail medicines Dispensed Medicine Medicine prepared by a pharmacist for a specific patient BNF Warning Label System System for applying standardized warning labels on medicine packaging Manufacturer's Obligations Details required on product labels and patient information leaflets Labelling Principles Inform, warn, and guide users on product name, dose, storage, etc. Standard Labelling Particulars Specific details required on medicinal product labels Excipients Inactive ingredients in a medicine with recognized effects Marketing Authorisation Authorization for a product to be placed on the market Batch Number Identification number assigned to a specific production batch OTC Medicines Over-the-counter medicines with specific labelling requirements Paracetamol Warnings Specific warnings for paracetamol usage to prevent overdose P & POM Medicines Classification of medicines with varying labelling regulations Exceptions to the rules Blister packs for MP with specific labeling requirements Small containers for MP E.g. eye drops, with specific labeling requirements Packaging of medicines on Rx Legal labeling requirements for dispensed medicines Medicines optimisation Introduced from Human Medicines Regulations 2012, aims to inform, warn, and guide 1/2 Labelling of containers Includes specific requirements like 'Keep out of sight and reach of children' Cautionary labels Include warnings like 'For external use only' Expiry dates and storage instructions Guidelines for labeling and storing medicines, e.g. 4 weeks after opening for certain products Follow establishment policy for labeling Extemporaneously-dispensed products and storage, e.g. 1-2 week expiry for freshly prepared BP products BNF Cautionary and Advisory Labels Supplementary labels applied to dispensed medicines as per BNF guidelines Pharmacy address Added by the program for labeling purposes Patient Information Leaflets (PIL) Officially approved leaflets with specific content requirements Package leaflets Must comply with specific regulations and contain essential information User testing Required for readability of patient information leaflets 2/2