wholesaling and licensing Flashcards
what is wholesaling?
anyone trading medicine to anyone other than a patient
what is needed to wholesale?
- wholesaler licence (wholesale distribution authorisation WDA)
- comply with good distribution practice GDP
- have a suitable ‘responsible person’ named on licence
what are WDA exemptions?
- pharmacies supplying stock to another pharmacy within same legal entity don’t need a licence
procedure for record keeping when POM is supplied from a pharmacy?
entry in POM register or signed order/invoice retained for 2 years
what is ML?
manufacturers license
what is advertising?
anything designed to promote the sale or supply
what class of medicines cannot be advertised?
CDs and POMs
what is the product exempt from advertising restrictions?
approved vaccine campaigns
what do you need to be able to advertise?
marketing authorisation MA, certificate of registration or traditional herbal registration
what are misleading adverts?
- withhold information
- where viewers may infer something different
content needed in an advert?
- clear it is and AD
- clearly identified as a medicinal product
- name, info for correct use, clear invitation to read PIL
what is the ‘blue guide’?
guidance on advertising and promoting published by MHRA