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

¹ Any per­son who ap­plies for a li­cence to trade whole­sale in medi­cin­al products or a li­cence to im­port ready-to-use medi­cin­al products, and who in ad­di­tion wishes to re­lease ready-to-use medi­cin­al products onto the mar­ket in their ca­pa­city as hold­er of the mar­ket­ing au­thor­isa­tion must ful­fil the re­quire­ments stated in Art­icle 11 and also en­sure that:

a.

an ana­lys­is sample suf­fi­cient for two com­plete re­lease ana­lyses is kept of each batch of a medi­cin­al product re­leased onto the mar­ket;

b.

an in­spec­tion sample is avail­able for each batch of a medi­cin­al product;

c.

gen­er­al and batch-spe­cif­ic doc­u­ment­a­tion of the man­u­fac­ture of a medi­cin­al product, in­clud­ing doc­u­ment­a­tion of its tech­nic­al re­lease and test­ing, is avail­able;

d.

a per­son is ap­poin­ted for phar­ma­covi­gil­ance who has the ap­pro­pri­ate spe­cial­ist know­ledge and is in charge of re­port­ing ad­verse drug re­ac­tions in ac­cord­ance with Art­icles 61 and 65 of the Thera­peut­ic Products Or­din­ance of 21 Septem­ber 2018⁴ (TPO);

e.

the re­quire­ments de­scribed in Art­icle 13 have been ful­filled.

² The per­son de­scribed in para­graph 1 let­ter d need not be on the staff of the com­pany; however, their re­spons­ib­il­it­ies must in all cases be de­scribed in writ­ing.

³ Any per­son who ap­plies for a li­cence to trade whole­sale in medi­cin­al products or a li­cence to im­port or ex­port medi­cin­al products and who in ad­di­tion, and in their ca­pa­city as cus­tom­er, wishes to have medi­cin­al products man­u­fac­tured or tested by a third party, must ful­fil the re­quire­ments de­scribed in Art­icle 11 and also en­sure that:

a.

the con­tract­or has the in­form­a­tion and qual­i­fic­a­tions ne­ces­sary to man­u­fac­ture the medi­cin­al product law­fully;

b.

each batch of a medi­cin­al product ful­fils the re­quire­ments es­tab­lished for com­pos­i­tion, man­u­fac­tur­ing pro­ced­ure, spe­cific­a­tions and qual­ity and is man­u­fac­tured in con­form­ity with the GMP rules;

c.

gen­er­al and batch-spe­cif­ic doc­u­ment­a­tion on the man­u­fac­ture of a medi­cin­al product, in­clud­ing doc­u­ment­a­tion of its tech­nic­al re­lease and test­ing, is avail­able.

⁴ Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.