Advertising Flashcards
What is the advertising of medicine defined as?
written or spoken words intended to encourage prescribing or supply by health professionals and use of medicines by the general public
- generally by means of highlighting qualities of the medicine
= ‘product claims’
What does the regulation of advertising apply to? What does it not apply to?
applies to (all media):
- journals, magazines and newspapers
- posters
- radio, TV, cinema
- internet
- point-of-sale materials, leaflets, booklets and other promotional materials that include specific product claims
- emails
does not apply to:
- reference material, factual informative statements or announcements, trade catalogues and price lists
= provided they do not make a product claim
What are the general rules in regards to advertising?
can only be done for products which have a valid Marketing Authorisation (MA)/a certificate of registration/traditional herbal registration may be advertised for medicinal purposes
- must be licensed
- responsibility for advertising and promotion of a medicine lies with the MA/certificate of registration/traditional herbal registration holder
- advertisements must be approved by MHRA before being used
= MHRA is the regulatory body
Who can advertisements about POMs be targeted at?
POMs may only be advertised to “persons qualified to prescribe or supply” (PQPS)
- doctors, dentists, nurses, pharmacists, optometrists, midwives
PQPS include professionals qualified to prescribe medicines under PGDs
- dieticians, occupational therapists
cannot be advertised to the public
What must the advertisement contain?
1 - essential information compatible with the Summary of Product Characteristics (SPC)
2 - the following particulars:
= license number, name and address of the MA holder, classification of the product, active ingredients, indications, dosage/methods/administration, side effects/contraindications, costs excluding VAT
3 - be legible, accurate, up-to-date, verifiable and sufficient to allow the recipient to form own opinion of the medicines therapeutic value
What are the regulations in regards to free samples?
can only be given to a person qualified to prescribe medicinal products (PQPS)
cannot be a narcotic or psychotropic substance
can only be given in response to a written request
must be marked as ‘Free sample. Not for resale’
What is meant by ‘inducements and hospitality’? What are the regulations in regards to inducements and hospitality?
is an object, situation, or action that is used as a means to influence another individual’s behaviour, but not necessarily with the intent to improperly influence that individual’s behaviour
it is an offence for a health professional to solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality or sponsorship
What products are/are not advertisements approved for?
advertising is permitted for P and GSL
advertising is not permitted for POMs, products for the purpose of inducing abortions or narcotic and psychotropic substances.
exception is for approved vaccination campaigns
What are advertising regulations for homeopathic products?
only the information specified on the labelling may be used in the advertising of registered homeopathic products
- constituents and potency
must not make mention of a specific indication
must be labelled
- contain ‘homeopathic product without approved indications’
should state a warning advising the user to consult a doctor if the symptoms persist during use of the product
What are advertising regulations for herbal products?
must include the statement: “traditional herbal medicinal product for use in …
- specify one or more indications for the product consistent with the terms of the registration
What happens if you don’t comply with MHRA regulations?
the MHRA offers to review material for regulated medicines and scrutinise advertisements for compliance. - usually demand retraction and sometimes the issue of a corrective statement if in breach
