Ordinance
on Licensing in the Medicinal Products Sector
(Medicinal Products Licensing Ordinance, MPLO)

¹ Hold­ers of a li­cence un­der Art­icle 21 are re­spons­ible for the cor­rect con­duct of trade with medi­cin­al products and the trace­ab­il­ity of the buy­ing and selling of medi­cin­al products.

² They en­sure that sup­pli­er and cus­tom­er are au­thor­ised to carry out the work pro­ced­ures that they per­form. They must be able to prove this.

³ They ob­tain in par­tic­u­lar the doc­u­ments show­ing the qual­ity of the medi­cin­al product and those show­ing at least the trans­ac­tion date, quant­ity, batch num­ber, ex­piry date and ex­act name of the medi­cin­al product and the name and ad­dress of the sup­pli­er and cus­tom­er, and keep these doc­u­ments.

⁴ They en­sure, in­clud­ing dur­ing trans­port, that the ne­ces­sary stor­age con­di­tions re­main with­in the lim­its de­term­ined by the man­u­fac­turer or stated on the pack­aging. They must be able to prove this in writ­ing.

⁵ They must provide the cus­tom­er on each de­liv­ery with de­tails of the ori­gin­al man­u­fac­turer and the ori­gin­al batch num­ber of the mer­chand­ise de­livered.

⁶ They must for­ward to the cus­tom­er or the sup­pli­er all in­form­a­tion provided by any sup­pli­er or cus­tom­er that per­tains to the qual­ity and safety of the medi­cin­al product or is rel­ev­ant for the au­thor­it­ies.

⁷ They must op­er­ate an ef­fect­ive pro­ced­ure for the batch re­call of medi­cin­al products.