The World Health Organ­i­sa­tion (WHO) was look­ing for feed­back from stake­hold­ers on a draft pol­i­cy which gives details of how med­ical devices, diag­nos­tics and oth­er med­ical prod­ucts should be man­aged right through the sup­ply chain while safe­guard­ing their avail­abil­i­ty with­in the remain­ing shelf-life.

The pol­i­cy should be com­plet­ed lat­er in the year and is valid for all med­ical prod­ucts in the sup­ply chain. Sup­pli­ers, donors, pro­cur­ers and dis­trib­u­tors can all put the pol­i­cy into oper­a­tion and it can be incor­po­rat­ed by WHO mem­ber states with­in their nation­al policies. 

The pol­i­cy is intend­ed to tack­le sev­er­al con­cerns, for exam­ple, mak­ing sure that there is ample reserve of med­ical prod­ucts with ade­quate remain­ing shelf-life in a country.

The pol­i­cy is intend­ed to tack­le sev­er­al con­cerns, for exam­ple, mak­ing sure that there is ample reserve of med­ical prod­ucts with ade­quate remain­ing shelf-life in a coun­try, deal­ing with access and sup­ply bar­ri­ers to med­ical prod­ucts, putting a stop to dump­ing and stock-outs, avoid­ing dona­tions of med­ical prod­ucts which are not suit­able and avert­ing the build-up of expired stock. Where nec­es­sary, it also wants to assist the nation­al autho­ri­sa­tion of impor­ta­tion of stock, where necessary. 

The WHO says that the infor­ma­tion could dif­fer depend­ing on the cat­e­go­ry of prod­uct, their vari­ety, how they are kept, resources in the coun­try and oth­er influ­ences. It makes a well-defined dif­fer­ence between man­u­fac­tur­ing and expiry/install by dates and says that for all prod­ucts with an expiry date, the cus­tomer or recip­i­ent should nev­er car­ry out re-test­ing in an effort to length­en the shelf-life. How­ev­er, the man­u­fac­tur­er or provider can get autho­ri­sa­tion for a new or extend­ed shelf-life from the rel­e­vant nation­al reg­u­la­to­ry author­i­ty and this should be applied to batch­es of the prod­uct to be deliv­ered and should have at least a one year shelf-life.

The pol­i­cy also explains when and how sup­pli­ers, recip­i­ents and nation­al author­i­ties can reach a deal about devi­a­tions from the remain­ing shelf-life policy. 

Fur­ther­more, the WHO explained that the pol­i­cy should be read in com­bi­na­tion with oth­er doc­u­ments and guide­lines, e.g. the guide­lines on good stor­age, sta­bil­i­ty test­ing and dis­tri­b­u­tion pro­ce­dures, the phar­ma­copeia etc. 

Source: Medtech Insight (an Infor­ma product)