Table 1: Summary of international risk communication schemes for medicines Scheme Criteria for inclusion Actions / outcomes Communications Criteria for removal Mandated by from scheme legislation? UK Black Triangle All licensed active Health professionals and Symbol () appears next to Inclusion in the scheme is No. scheme ingredients* consumers are encouraged drug name in: reassessed 2 years. Requirements for to report all suspected The symbol is removed [Currently being All biosimilars British National Formulary triangle in reactions to these when the safety profile of phased out before advertising are in products. the drug is ‘well A product containing British National Formulary for introduction of the industry code established’. previously licensed active Children European Medicines Industry required to of practice. ingredients may be included Agency’s additional report all serious Monthly Index of Medical if it is: monitoring scheme.] suspected adverse drug Specialities Association of the reactions to a black a new combination, British Pharmaceutical triangle product from Industry Medicines within the UK and EU a new route of Compendium within 15 days. administration or drug delivery system, advertising material a significant new indication in Drug Safety Update (a that may alter established monthly publication for health risk–benefit profile, or professionals from the MHRA). an established medicine to be used in new patient population.
Table 1: Summary of international risk communication schemes for medicines Scheme Criteria for inclusion Actions / outcomes Communications Criteria for removal from scheme Mandated by legislation? UK Black Triangle scheme [Currently being phased out before introduction of European Medicines Agency’s additional monitoring scheme.] All licensed active ingredients* All biosimilars A product containing previously licensed active ingredients may be included if it is: a new combination, a new route of administration or drug delivery system, a significant new indication that may alter established risk–benefit profile, or an established medicine to be used in new patient population. Health professionals and consumers are encouraged to report all suspected reactions to these products. Industry required to report all serious suspected adverse drug reactions to a black triangle product from within the UK and EU within 15 days. Symbol () appears next to drug name in: British National Formulary British National Formulary for Children Monthly Index of Medical Specialities Association of the British Pharmaceutical Industry Medicines Compendium advertising material in Drug Safety Update (a monthly publication for health professionals from the MHRA). Inclusion in the scheme is reassessed 2 years. The symbol is removed when the safety profile of the drug is ‘well established’. No. Requirements for triangle in advertising are in the industry code of practice.
consult-opr-ntm-scheme-130513.docx