Advertising, Labelling + Packaging Requirements Flashcards
(32 cards)
What is advertising of a medicine ?
- anything designed to promote the prescription, supply, sale or use of that medicinal product
What medicines are advertisements prohibited for ?
- CD’S and POM’s
- exceptions for approved vaccine campgains
What are the general principles of advertising ?
- Ads must only be published if the product has a MA
- Ads must comply with the SPC
- Ads should encourage rational use, avoiding exaggeration and being non-misleading.
What are the rules for hospitality in advertising to healthcare professionals?
• hospitality may only be given to healthcare professionals (HCPs) qualified to prescribe or supply.
• it must be reasonable and related to scientific or professional meetings.
- gifts or financial advantages are only allowed if they are inexpensive and relevant to the profession.
Who monitors medicinal product advertising?
• self-regulatory bodies like the UK ASA (Advertising Standards Authority)
• legal provisions are enforced by health ministers
What are the form and content requirements for advertising medicinal products?
- Clear identification that it is an advertisement and that the product is a medicinal product.
Must include:
- The name of the medicinal product.- The common name of the active ingredients
- Information necessary for the correct use of the product.
- an invitation to read the package leaflet or instructions carefully.
What guidance is available for advertising and promoting medicines in the UK?
- The ‘Blue Guide’ published by MHRA provides detailed guidance on advertising and promoting medicines in the UK
What is the definition of immediate packaging under HMR 2012?
- refers to the container or packaging in direct contact with the medicinal product.
What is the definition of a package under HMR 2012?
- container or any box/packet enclosing one or more containers of the product
- and any additional box enclosing the package.
What is meant by medicines on prescription?
- medicines on prescription are those that are dispensed against a prescription
What are the general labelling regulations for medicinal products under HMR 2012?
• All containers and packages must be legal, comprehensible, and indelible.
• must be in English, unless it’s an orphan medicinal product (to treat rare disease)
What information must be included on the label of a medicinal product ?
- name, strength, and form of the medicinal product
- whether the product is for babies, children, or adults
- common names of up to three active substances.
- expiry date (month and year).
- batch number of the manufacturer.
- administration method and route (if necessary)
- pharmaceutical form + contents by weight volume or number of doses of the product
- name and address of MA holder
What additional labelling requirement does Blister pack need ?
- name and address of MA holder
What information is legally required on a dispensed medicinal product?
• Patient’s name.
• Supplying pharmacy’s name and address.
• Date of dispensing.
• Name of the medicine.
• Directions for use (e.g., “Take ONE tablet THREE times a day”).
• Precautions for use (e.g., “For external use only”).
What does the RPS recommend also appears on the dispensing label ?
- Keep out of the reach and sight of children’
- Use this medicine only on your skin’ where applicable.
What specific recommendation applies to secure environments for dispensing labels?
- Include the prisoner number as a definitive patient identifier.
What other optional information can pharmacists add to a dispensing label?
• Additional information deemed necessary for safe use.
• Quantity of medicine (not legally required but good practice).
• BNF advisory and cautionary labels (at the pharmacist’s discretion).
What are BNF Cautionary and Advisory Labels, and where can they be found?
• BNF codes appear next to drugs in the BNF.
• These labels provide specific cautionary or advisory information about the drug.
How should BNF Cautionary and Advisory Labels be used?
• Recommended to be added to the dispensing label.
• The information should also be provided during consultations with patients or carers.
What does the prescription endorsement “NCL” mean?
• NCL stands for “No Cautionary Label.”
• Prescribers can endorse a prescription with NCL if cautionary labels are not required.
Why should the actual container of a medicine be labeled instead of the outer container?
- the outer container may be discarded, leading to loss of labelling information
- labelling should be applied directly to the actual container (e.g., inhaler or cream tube).
How can pharmacists optimize labelling ?
- pharmacists can substitute directions, names, or precautions with a similar alternative if deemed inappropriate, without contacting the prescriber
- must keep a record of any changes.
What is required for assembly or pre-packaging of medicines by a pharmacy?
- requires an MHRA license if medicines are supplied to a separate legal entity (e.g., one NHS Trust to another).
What must be included on the label when medicines are broken down from bulk?
- name of the medicine.
- quantity in the container
- quantitative particulars (ingredients).
- handling and storage requirements (if applicable).
- expiry date.
- batch reference number (e.g., LOT number).
