Federal Act
on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA)

¹ Ready-to-use medi­cin­al products and veter­in­ary medi­cin­al products in­ten­ded for the man­u­fac­ture of medi­cin­al food­stuffs (pre­mixed medi­cin­al products) may be placed on the mar­ket only if au­thor­ised by the Agency; the fore­go­ing is without pre­ju­dice to in­ter­na­tion­al agree­ments on the re­cog­ni­tion of mar­ket­ing au­thor­isa­tions.

² The fol­low­ing shall be ex­empt from au­thor­isa­tion:

a.³²

medi­cin­al products pre­pared ac­cord­ing to a doc­tor’s pre­scrip­tion by a pub­lic phar­macy or a hos­pit­al phar­macy, or un­der man­date to the lat­ter by an­oth­er es­tab­lish­ment hold­ing a man­u­fac­tur­ing li­cence, and for a giv­en per­son or group of per­sons or for a giv­en an­im­al or live­stock (ma­gis­tral for­mula); on the basis of a pre­scrip­tion, the medi­cin­al product may be man­u­fac­tured by the pub­lic phar­macy or the hos­pit­al phar­macy as re­quired or on a small in­dus­tri­al scale but may only be dis­pensed on a doc­tor’s pre­scrip­tion;

b.³³

medi­cin­al products pre­pared as re­quired or on a small in­dus­tri­al scale by a pub­lic phar­macy, a hos­pit­al phar­macy, a drug­store or by an­oth­er es­tab­lish­ment hold­ing a man­u­fac­tur­ing li­cence, con­form­ing to a spe­cial mono­graph of the Phar­ma­co­poeia or an­oth­er phar­ma­co­poeia or a for­mu­lary re­cog­nised by the Agency, and which are sup­plied to their own cus­tom­ers (of­fi­cin­al for­mula);

c.³⁴

non-pre­scrip­tion medi­cin­al products pre­pared as re­quired or on a small in­dus­tri­al scale by a pub­lic phar­macy, a hos­pit­al phar­macy, a drug­store or by an­oth­er es­tab­lish­ment hold­ing a man­u­fac­tur­ing li­cence, with­in the lim­its of the es­tab­lish­ment’s right to dis­pense in com­pli­ance with Art­icle 25, ac­cord­ing to its own for­mula or a for­mula pub­lished in the spe­cial­ised lit­er­at­ure, which are in­ten­ded for dis­pens­ing to the es­tab­lish­ment's own cus­tom­ers;

c^bis.³⁵ medi­cin­al products for which it is proven that there is no au­thor­ised or avail­able al­tern­at­ive medi­cin­al product that is ap­plic­able and equi­val­ent and which are man­u­fac­tured in a hos­pit­al phar­macy in ac­cord­ance with the hos­pit­al’s own phar­ma­ceut­ic­als list, on a small in­dus­tri­al scale, and are in­ten­ded for dis­pens­ing to its own cus­tom­ers;

d.

medi­cin­al products in­ten­ded for clin­ic­al tri­als;

e.

medi­cin­al products which can­not be stand­ard­ised;

f.³⁶

medicinal products that were authorised in a canton on 1 January 2002 and which were still on the market when the Amendment of 18 March 2016 came into force; they must be labelled accordingly and may only be placed on the market in the canton concerned and only supplied by persons entitled to supply medicinal products under this Act.

^2bis An es­tab­lish­ment with a man­u­fac­tur­ing li­cence may be com­mis­sioned to man­u­fac­ture medi­cin­al products (con­tract man­u­fac­ture) in ac­cord­ance with para­graph 2 a–c^bis.³⁷

^2terCom­pan­ies hold­ing a man­u­fac­tur­ing li­cence is­sued by the Agency may man­u­fac­ture a com­ple­ment­ary medi­cine for which no al­tern­at­ive and equi­val­ent medi­cin­al product is demon­strably avail­able or au­thor­ised, even without a con­tract man­u­fac­tur­ing or­der in ac­cord­ance with para­graph 2^bis, and mar­ket them to com­pan­ies which are au­thor­ised to man­u­fac­ture these products in ac­cord­ance with para­graph 2 let­ters a, b and c. A com­pany may not man­u­fac­ture more than 100 pack­ages of such a medi­cin­al product with a max­im­um total of 3,000 daily doses; in the case of homeo­path­ic and an­thro­po­soph­ic medi­cin­al products, this re­stric­tion ap­plies to each di­lu­tion in­di­vidu­ally.³⁸

^2quater The Fed­er­al Coun­cil shall lay down the qual­it­at­ive and quant­it­at­ive cri­ter­ia for the medi­cin­al products man­u­fac­tured in ac­cord­ance with para­graphs 2 let­ters a–c^bis and 2^bis, and the qual­it­at­ive cri­ter­ia for the medi­cin­al products man­u­fac­tured in ac­cord­ance with para­graph 2^ter.³⁹

³ The Fed­er­al Coun­cil may make pro­vi­sion for a re­quire­ment of au­thor­isa­tion for the pro­duc­tion or man­u­fac­tur­ing pro­cess used in mak­ing medi­cin­al products which can­not be stand­ard­ised.

⁴ …⁴⁰