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

In this Or­din­ance:

a.

act­ive phar­ma­ceut­ic­al in­gredi­ents means sub­stances or mix­tures to which the ef­fect of a ready-to-use medi­cin­al product is at­trib­uted and which are used in ready-to-use medi­cin­al products;

b.

im­mun­o­lo­gic­al medi­cin­al products means medi­cin­al products ad­min­istered to cre­ate act­ive or pass­ive im­munity or help dia­gnose im­munity status, in par­tic­u­lar vac­cines, tox­ins and sera, and medi­cin­al products in­ten­ded to identi­fy or cause a par­tic­u­lar ac­quired modi­fic­a­tion of the im­mune re­sponse to an al­ler­gising sub­stance, such as al­ler­gens;

c.

ready-to-use medi­cin­al product means a medi­cin­al product that has been re­leased tech­nic­ally on the basis of the en­tire man­u­fac­tur­ing pro­cess and is avail­able in a form and present­a­tion en­abling it to be used as in­ten­ded;

d.

blood means hu­man blood;

e.

labile blood products means products that are ex­trac­ted from donated blood, either dir­ectly or in one or a small num­ber of man­u­fac­tur­ing steps, and which quickly change without any ex­tern­al in­flu­ence, in par­tic­u­lar cell pre­par­a­tions and plasma;

f.

med­ic­ated feed­ing­stuffs means ready-to-use veter­in­ary medi­cin­al products com­pris­ing a mix­ture of pre­mixed medi­cin­al products and feed­stuffs or drink­ing wa­ter;

g.

pre­mixed medi­cin­al products means veter­in­ary medi­cin­al products, com­pris­ing act­ive in­gredi­ents and ex­cipi­ents in­ten­ded for mix­ing with an­im­al feed­stuffs or drink­ing wa­ter or for dir­ect ad­min­is­tra­tion to a cat­egory of an­im­als;

h.

batch means a ho­mo­gen­eous and defined quant­ity of raw ma­ter­i­als, medi­cin­al products or pack­aging ma­ter­i­al pre­pared in one man­u­fac­tur­ing op­er­a­tion or in a series of man­u­fac­tur­ing op­er­a­tions;

i.

sys­tem to en­sure the phar­ma­ceut­ic­al qual­ity of medi­cin­al products means the whole range of meas­ures taken to en­sure that medi­cin­al products have the ne­ces­sary qual­ity for their in­ten­ded use;

j.

med­ic­al per­son­nel means doc­tors, dent­ists, veter­in­ary sur­geons and phar­macists;

k.

fa­cil­it­ies means in­di­vidu­al parts or groups of build­ings or sys­tems, in one or more loc­a­tions, and vehicles and oth­er re­sources in­volved in the man­u­fac­tur­ing, test­ing, im­port and ex­port of medi­cin­al products, in whole­sale trad­ing or trad­ing abroad with medi­cin­al products, or in broker­age or agency activ­it­ies re­lated to medi­cin­al products;

l.

whole­sale trade means all activ­it­ies re­lat­ing to the paid or un­paid trans­fer­ring or pro­vi­sion of medi­cin­al products – from ac­quis­i­tion, stock­age, stor­age, of­fer­ing and ad­vert­ising to the sup­ply of medi­cin­al products – to per­sons au­thor­ised to trade in them, pro­cess them, dis­pense them or use them in a pro­fes­sion­al ca­pa­city;

m.

im­port means all the activ­it­ies lis­ted un­der let­ter l re­lat­ing to the trans­port of medi­cin­al products in­to Switzer­land;

n.

ex­port means all the activ­it­ies lis­ted un­der let­ter l re­lat­ing to the trans­port of medi­cin­al products out of Switzer­land;

o.

tech­nic­al re­lease means the de­cision taken on com­ple­tion of man­u­fac­ture or of a step in the man­u­fac­tur­ing pro­cess con­firm­ing that the batch in ques­tion con­forms to the re­quire­ments of in­tern­al or ex­tern­al cli­ents in terms of com­pos­i­tion, man­u­fac­tur­ing pro­ced­ure, spe­cific­a­tions and qual­ity and was man­u­fac­tured in com­pli­ance with the rules of Good Man­u­fac­tur­ing Prac­tice (GMP³) as shown in An­nex 1 or 2.