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

¹ This Or­din­ance reg­u­lates:

a.

the man­u­fac­ture of medi­cin­al products;

b.

whole­sale trad­ing in medi­cin­al products;

c.

the im­port, ex­port and trans­it trade in medi­cin­al products;

d.

trad­ing in medi­cin­al products in for­eign coun­tries from Switzer­land;

e.

the ex­tract­ing of blood for trans­fu­sions or for the man­u­fac­ture of medi­cin­al products to­geth­er with oth­er es­sen­tial ele­ments of trans­fu­sion safety in hand­ling blood and labile blood products;

f.

broker­age or agency activ­it­ies in con­nec­tion with medi­cin­al products;

g.

tem­por­ary li­cences to use medi­cin­al products in ac­cord­ance with Art­icle 9b para­graph 1 TPA.

² With the ex­cep­tion of Art­icles 27, 28 and 47, this Or­din­ance ap­plies by ana­logy to the hand­ling of trans­plant products as de­scribed in Art­icle 2 para­graph 1 let­ter c of the Trans­plant­a­tion Or­din­ance of 16 March 2007².

³ Art­icles 29–38 do not ap­ply to trans­plant products de­scribed in Art­icle 2 para­graph 1 let­ter c num­ber 2 of the Trans­plant­a­tion Or­din­ance of 16 March 2007.

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.

¹ Any per­son ap­ply­ing to the Swiss Agency for Thera­peut­ic Products (Swiss­med­ic) for a man­u­fac­tur­ing li­cence must prove that:

a.

a sys­tem to en­sure the phar­ma­ceut­ic­al qual­ity of medi­cin­al products is in op­er­a­tion and that the com­pany man­age­ment and staff in the in­di­vidu­al de­part­ments con­cerned take an act­ive part in such a sys­tem;

b.

each de­part­ment has a suf­fi­cient num­ber of qual­i­fied and com­pet­ent staff mem­bers to en­able it to achieve its qual­ity tar­gets;

c.

a Re­spons­ible Per­son as de­scribed in Art­icles 5 and 6 is avail­able;

d.

the fa­cil­it­ies are or­gan­ised in an ap­pro­pri­ate way;

e.

the fa­cil­it­ies are de­signed, struc­tured, main­tained and mod­ern­ised reg­u­larly to guar­an­tee the safe man­u­fac­ture of medi­cin­al products and the premises and equip­ment that can in­flu­ence the qual­ity of the medi­cin­al products are qual­i­fied for their pur­pose;

f.

a doc­u­ment­a­tion sys­tem is avail­able to provide the work­ing in­struc­tions, pro­cess de­scrip­tions and pro­to­cols of the rel­ev­ant man­u­fac­tur­ing pro­ced­ures;

g.

the man­u­fac­tur­ing, test­ing and clean­ing pro­ced­ures are val­id­ated;

h.

qual­ity con­trol is sep­ar­ate from man­u­fac­ture;

i.

the ob­lig­a­tions de­scribed in Art­icles 4 and 7 and in re­la­tion to the man­u­fac­ture of labile blood products and the ob­lig­a­tions in Art­icles 28–38 are met.

² The work of all per­sons oc­cupy­ing key po­s­i­tions in the com­pany must be set out in job de­scrip­tions and their hier­arch­ic­al po­s­i­tions set out in or­gan­isa­tion­al charts.

³Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.

¹ Hold­ers of a li­cence un­der Art­icle 3 are re­spons­ible for the pro­cessing and work­ing pro­ced­ures they carry out.

² Medi­cin­al product man­u­fac­ture must be car­ried out in ac­cord­ance with the rules of Good Man­u­fac­tur­ing Prac­tice de­scribed in An­nex 1 or 2.

³ In the man­u­fac­ture of com­ple­ment­ary medi­cin­al products, the GMP rules must be fol­lowed by ana­logy and the spe­cif­ic reg­u­la­tions for the ther­apies con­cerned which are laid down in the phar­ma­co­poei­as re­cog­nised by Swiss­med­ic must be ad­hered to.

¹ The Re­spons­ible Per­son is re­spons­ible for the dir­ect tech­nic­al su­per­vi­sion of the fa­cil­it­ies and in par­tic­u­lar en­sures that the medi­cin­al products are handled ap­pro­pri­ately.

² They are re­spons­ible for the qual­ity of the man­u­fac­tured medi­cin­al products and en­sure that the leg­al pro­vi­sions ap­plic­able to thera­peut­ic products are ob­served.

³ They are au­thor­ised to is­sue in­struc­tions with­in their sphere of activ­ity.

⁴ They and the com­pany man­age­ment jointly en­sure their dep­u­tisa­tion by ad­equately qual­i­fied spe­cial­ists.

⁵ If the fa­cil­it­ies cease op­er­a­tions, or if op­er­a­tions can be ex­pec­ted to cease im­min­ently, the Re­spons­ible Per­son must re­port this situ­ation to Swiss­med­ic without delay.

⁶ They may not sit on one of the fa­cil­it­ies’ su­per­vis­ory com­mit­tees and must de­cide on the re­lease or re­jec­tion of batches in­de­pend­ently of the com­pany’s man­age­ment. Swiss­med­ic may grant a li­cence to small fa­cil­it­ies without such se­greg­a­tion if they can­not im­ple­ment the se­greg­a­tion be­cause of their size.

⁷ If the size and nature of the fa­cil­it­ies per­mit this activ­ity to be per­formed on a part-time basis, re­spons­ib­il­it­ies must be set out in writ­ing and the min­im­um num­ber of hours dur­ing which the per­son must be present in the fa­cil­ity must be de­term­ined.

¹ The Re­spons­ible Per­son must have the ne­ces­sary tech­nic­al know­ledge and be trust­worthy. They must also ful­fil the fol­low­ing pro­fes­sion­al re­quire­ments:

a.

for the man­u­fac­ture of ready-to-use medi­cin­al products or in­ter­me­di­ate products, the Re­spons­ible Per­son must be a qual­i­fied phar­macist with pro­fes­sion­al ex­per­i­ence;

b.

for the man­u­fac­ture of labile blood products or im­mun­o­lo­gic­al medi­cin­al products the Re­spons­ible Per­son must have a uni­versity de­gree in medi­cine or a life sci­ence and have the ne­ces­sary pro­fes­sion­al ex­per­i­ence;

c.

for the man­u­fac­ture of act­ive phar­ma­ceut­ic­al in­gredi­ents or med­ic­ated feed­ing­stuffs, the Re­spons­ible Per­son must have a uni­versity de­gree in a life sci­ence and the ne­ces­sary pro­fes­sion­al ex­per­i­ence;

d.

for the man­u­fac­ture of ra­dio­phar­ma­ceut­ic­als, the Re­spons­ible Per­son must have a cer­ti­fic­ate is­sued by the European As­so­ci­ation of Nuc­le­ar Medi­cine for Ra­dio­phar­macy and have the ne­ces­sary ex­per­i­ence.

² If a per­son can prove suf­fi­cient know­ledge and ex­per­i­ence, Swiss­med­ic may also re­cog­nise oth­er pro­fes­sion­al qual­i­fic­a­tions for this job.

³ Swiss­med­ic may spe­cify fur­ther de­tails to Art­icle 5 and this Art­icle, in par­tic­u­lar the min­im­um num­ber of hours dur­ing which the Re­spons­ible Per­son must be present in the fa­cil­ity and the re­quire­ments that they must ful­fil in terms of train­ing and ex­per­i­ence.

¹ The Re­spons­ible Per­son de­cides on the tech­nic­al re­lease of a product batch.

² They is­sue a batch cer­ti­fic­ate 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 GMP rules in ac­cord­ance with An­nex 1 or 2.

¹ Hos­pit­al phar­macists and per­sons in pos­ses­sion of a can­ton­al li­cence in ac­cord­ance with Art­icle 30 TPA who pre­pare medi­cin­al products in ac­cord­ance with Art­icle 9 para­graph 2 let­ters a–c^bis or para­graph 2^bis TPA must carry out a risk as­sess­ment in ac­cord­ance with An­nex 3. This pro­vi­sion does not ap­ply to the cases set out in para­graph 6 be­low.

² The con­duct of these risk as­sess­ments should be doc­u­mented. This doc­u­ment­a­tion should be presen­ted to the can­ton­al su­per­vis­ory au­thor­ity on re­quest.

³ If the risk as­sess­ment pro­duces a value be­low the threshold spe­cified in An­nex 3, a can­ton­al man­u­fac­tur­ing li­cence is re­quired in­stead of a li­cence is­sued by Swiss­med­ic.

⁴ The li­cence is gran­ted if it can be en­sured that the rules of Good Man­u­fac­tur­ing Prac­tice for small quant­it­ies of medi­cin­al products in ac­cord­ance with An­nex 2 are ob­served.

⁵ The can­tons reg­u­late the oth­er con­di­tions for the grant­ing of the li­cence in ac­cord­ance with para­graph 3 and peri­od­ic­ally carry out fa­cil­ity checks.

⁶ Any per­son who man­u­fac­tures ra­dio­phar­ma­ceut­ic­als re­quires a li­cence gran­ted by Swiss­med­ic.

The can­tons may con­duct sur­veys among man­u­fac­tur­ers con­cern­ing the medi­cin­al products pre­pared in ac­cord­ance with Art­icle 9 para­graph 2 let­ters a–c^bis and para­graph 2^bis TPA. The man­u­fac­tur­ers are ob­liged to provide the ne­ces­sary in­form­a­tion to the can­tons on re­quest.

The pre­par­a­tion of medi­cin­al products in ac­cord­ance with Art­icle 9 para­graph 2 let­ter f TPA is ex­empt from li­cens­ing by Swiss­med­ic.

¹ Any per­son ap­ply­ing for a li­cence to im­port medi­cin­al products must prove that:

a.

a sys­tem to en­sure the phar­ma­ceut­ic­al qual­ity of medi­cin­al products is in op­er­a­tion and that the com­pany man­age­ment and staff in the in­di­vidu­al de­part­ments con­cerned take an act­ive part in such a sys­tem;

b.

each de­part­ment has a suf­fi­cient num­ber of qual­i­fied and com­pet­ent staff mem­bers to en­able it to achieve its qual­ity tar­gets;

c.

the tasks of all per­sons oc­cupy­ing key po­s­i­tions in the com­pany are set out in job de­scrip­tions and their hier­arch­ic­al po­s­i­tions are set out in or­gan­isa­tion­al charts;

d.

a Re­spons­ible Per­son in ac­cord­ance with Art­icles 17 and 18 is avail­able;

e.

the fa­cil­it­ies are or­gan­ised in an ap­pro­pri­ate way;

f.

the fa­cil­it­ies are de­signed, struc­tured, main­tained and mod­ern­ised reg­u­larly to guar­an­tee the safe im­port of medi­cin­al products;

g.

a doc­u­ment­a­tion sys­tem is avail­able that com­prises the work­ing in­struc­tions, pro­cess de­scrip­tions and pro­to­cols of the rel­ev­ant im­port pro­ced­ures;

h.

the re­quire­ments and ob­lig­a­tions of Art­icles 15 and 16 are ful­filled;

i.

the man­u­fac­turer of the medi­cin­al products to be im­por­ted has a man­u­fac­tur­ing li­cence is­sued by a coun­try whose GMP con­trol sys­tem is con­sidered by Swiss­med­ic to be equi­val­ent, or which states that the medi­cin­al products are man­u­fac­tured in com­pli­ance with the GMP rules val­id in Switzer­land.

² Any per­son who ap­plies for a li­cence to trade whole­sale in medi­cin­al products or a li­cence to ex­port medi­cin­al products must ful­fil the re­quire­ments stated in para­graph 1 let­ters a–h; let­ters f and g ap­ply by ana­logy.

³ Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.

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.

¹ The Re­spons­ible Per­son em­ployed by the hold­er of the mar­ket­ing au­thor­isa­tion de­cides on the mar­ket re­lease of a batch be­fore it is placed on the mar­ket.

² They check wheth­er:

a.

a val­id batch cer­ti­fic­ate is­sued by the man­u­fac­turer is avail­able and wheth­er the batch was man­u­fac­tured in con­form­ity with the GMP rules de­scribed in An­nex 1;

b.

the batch in ques­tion ful­fils the re­quire­ments of the au­thor­isa­tion;

c.

the con­di­tions de­scribed in Art­icles 11 and 12 have been ful­filled; and

d.

the en­tire sup­ply chain is in con­form­ity with the au­thor­isa­tion and the GDP⁵ rules de­scribed in An­nex 4.

³ Swiss­med­ic may spe­cify ad­di­tion­al checks.

⁴ The Re­spons­ible Per­son con­firms that the checks de­scribed in para­graphs 2 and 3 have been per­formed.

If ready-to-use medi­cin­al products are man­u­fac­tured in a State with which Switzer­land has not signed an agree­ment on the mu­tu­al re­cog­ni­tion of the GMP con­trol pro­ced­ures and there are jus­ti­fied doubts about the safety or qual­ity of the batches to be im­por­ted, Swiss­med­ic may or­der that each batch un­der­go reana­lys­is in Switzer­land.

¹ Hold­ers of a li­cence un­der Art­icle 11 bear re­spons­ib­il­ity for the activ­it­ies they carry out.

² The im­port, ex­port and whole­sale trad­ing of medi­cin­al products must con­form to the GDP rules de­scribed in An­nex 4.⁶

Li­cence hold­ers must keep the fol­low­ing doc­u­ments in par­tic­u­lar in or­der to en­sure trace­ab­il­ity:

a.

the name of the medi­cin­al product;

b.

the trans­ac­tion date;

c.

the quant­ity;

d.

the batch num­ber;

e.

the ex­piry date;

f.

the name and ad­dress of the sup­pli­er and the cus­tom­er.

¹ The Re­spons­ible Per­son is re­spons­ible for the dir­ect tech­nic­al su­per­vi­sion of the fa­cil­it­ies and in par­tic­u­lar en­sures that the medi­cin­al products are handled ap­pro­pri­ately.

² They en­sure that the im­port, ex­port and whole­sale trad­ing in medi­cin­al products are in con­form­ity with the GDP rules de­scribed in An­nex 4 and en­sure that the leg­al pro­vi­sions ap­plic­able to thera­peut­ic products are ob­served.

³ They are au­thor­ised to is­sue in­struc­tions with­in their sphere of activ­ity.

⁴ They and the com­pany man­age­ment jointly en­sure their dep­u­tisa­tion by ad­equately qual­i­fied spe­cial­ists.

⁵ If the fa­cil­it­ies cease op­er­a­tions, or if op­er­a­tions can be ex­pec­ted to cease im­min­ently, they must re­port this situ­ation to Swiss­med­ic without delay.

⁶ They may not sit on one of the fa­cil­it­ies’ su­per­vis­ory com­mit­tees and must de­cide on the re­lease or re­jec­tion of batches in­de­pend­ently of the com­pany’s man­age­ment. Swiss­med­ic can grant a li­cence to small fa­cil­it­ies without such se­greg­a­tion if they can­not im­ple­ment the se­greg­a­tion be­cause of their size.

⁷ If the size and nature of the fa­cil­it­ies per­mit this activ­ity to be per­formed on a part-time basis, re­spons­ib­il­it­ies must be spe­cified in writ­ing and the min­im­um num­ber of hours dur­ing which the per­son must be present in the fa­cil­ity must be de­term­ined.

¹ The Re­spons­ible Per­son must have the ne­ces­sary train­ing, tech­nic­al know­ledge and ex­per­i­ence, and be trust­worthy.

² To ob­tain a li­cence in ac­cord­ance with Art­icle 12 para­graphs 1 and 3, the Re­spons­ible Per­son must also ful­fil the fol­low­ing re­quire­ments and tasks:⁷

a.

The Re­spons­ible Per­son must pos­sess a de­gree in phar­ma­co­logy and the ne­ces­sary ex­per­i­ence in the man­u­fac­ture of ready-to-use medi­cin­al products. If the per­son can prove suf­fi­cient know­ledge and ex­per­i­ence in the medi­cin­al products sec­tor, Swiss­med­ic may also re­cog­nise oth­er pro­fes­sion­al qual­i­fic­a­tions for this job.

b.

In grant­ing mar­ket re­lease, the Re­spons­ible Per­son en­sures that each batch is not placed on the Swiss mar­ket un­til all the ap­plic­able con­di­tions of Art­icles 11–13 have been ful­filled and the en­tire sup­ply chain is in con­form­ity with the au­thor­isa­tion and the GDP rules.

³ Swiss­med­ic may spe­cify fur­ther de­tails to Art­icle 17 and this Art­icle, in par­tic­u­lar the min­im­um num­ber of hours dur­ing which the Re­spons­ible Per­son must be present in the fa­cil­ity and the re­quire­ments that they must ful­fil in terms of train­ing and ex­per­i­ence.

¹ The im­port of medi­cin­al products for use in a clin­ic­al tri­al in ac­cord­ance with the pro­tocol for that tri­alre­quires a li­cence is­sued by Swiss­med­ic. This li­cence also cov­ers the in­di­vidu­al im­port of im­mun­o­lo­gic­al medi­cin­al products and of blood and blood products.

² A li­cence is not re­quired if the im­port­ing per­son or in­sti­tu­tion already holds a li­cence as de­scribed in Art­icle 11.

¹ Doc­tors and veter­in­ary sur­geons who prac­tise their pro­fes­sion on both sides of the bor­der in ac­cord­ance with cur­rent in­ter­na­tion­al agree­ments may im­port and ex­port ready-to-use medi­cin­al products in small quant­it­ies without a li­cence in­so­far as this is in­dis­pens­able for prac­tising their pro­fes­sion.

² Any per­son hold­ing a can­ton­al li­cence to dis­pense medi­cines as a pub­lic phar­macy, hos­pit­al phar­macy or drug­store does not re­quire an op­er­at­ing li­cence from Swiss­med­ic for the whole­sale trade in medi­cines oc­ca­sion­ally con­duc­ted with oth­er hold­ers of a can­ton­al dis­pens­ing li­cence in the can­ton in which they are es­tab­lished. If the medi­cines are sold to more than five cus­tom­ers a year or if dis­tri­bu­tion is trans­ferred to a third party, an op­er­at­ing li­cence from Swiss­med­ic is re­quired.

³ For whole­sale trade activ­it­ies in ac­cord­ance with para­graph 2, the GDP rules de­scribed in An­nex 4 ap­ply mu­tatis mutandis.

⁴ The can­ton­al au­thor­it­ies must be no­ti­fied of whole­sale trade activ­it­ies in ac­cord­ance with para­graph 2.

¹ Any per­son ap­ply­ing for a li­cence to trade in for­eign coun­tries must prove that:

a.

the fa­cil­it­ies op­er­ate a sys­tem to en­sure the phar­ma­ceut­ic­al qual­ity of medi­cin­al products and that the com­pany man­age­ment and staff in the in­di­vidu­al de­part­ments con­cerned take an act­ive part in this sys­tem;

b.

a Re­spons­ible Per­son in ac­cord­ance with Art­icle 23 is avail­able;

c.

the fa­cil­it­ies are or­gan­ised in an ap­pro­pri­ate way;

d.

a doc­u­ment­a­tion sys­tem is avail­able that com­prises the work­ing in­struc­tions, pro­cess de­scrip­tions and pro­to­cols of the rel­ev­ant pro­ced­ures in­volved in the activ­it­ies;

e.

due di­li­gence is ex­er­cised as de­scribed in Art­icle 22.

² Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.

³ The li­cence does not en­title the hold­er to is­sue man­u­fac­tur­ing or­ders.

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.

¹ Re­spons­ible Per­sons carry out the dir­ect tech­nic­al su­per­vi­sion of the fa­cil­it­ies and, in par­tic­u­lar, en­sure or­derly trad­ing in medi­cin­al products.

² They are au­thor­ised to is­sue in­struc­tions with­in their sphere of activ­ity.

³ They en­sure their dep­u­tisa­tion by ad­equately qual­i­fied spe­cial­ists.

⁴ If the fa­cil­it­ies cease op­er­a­tions, or if op­er­a­tions can be ex­pec­ted to cease im­min­ently, they must re­port this situ­ation to Swiss­med­ic without delay.

⁵ They must have the ne­ces­sary train­ing, ex­pert­ise and ex­per­i­ence, and be trust­worthy.

⁶ They de­cide in­de­pend­ently of the com­pany’s man­age­ment and may not sit on any of the fa­cil­it­ies’ su­per­vis­ory com­mit­tees. Swiss­med­ic may grant a li­cence to small fa­cil­it­ies without such se­greg­a­tion if they can­not im­ple­ment the se­greg­a­tion be­cause of their size.

⁷ If the size and nature of the fa­cil­it­ies per­mit this activ­ity to be per­formed on a part-time basis, re­spons­ib­il­it­ies must be spe­cified in writ­ing and the min­im­um num­ber of hours that the Re­spons­ible Per­son must be present in the fa­cil­ity must be de­term­ined.

⁸ Swiss­med­ic may spe­cify fur­ther de­tails, in par­tic­u­lar the min­im­um num­ber of hours that the Re­spons­ible Per­son must be present in the fa­cil­ity and the re­quire­ments that they must ful­fil in terms of train­ing and ex­per­i­ence.

¹ Any per­son ap­ply­ing for a li­cence to per­form broker­age or agency activ­it­ies must prove that:

a.

the fa­cil­it­ies op­er­ate a func­tion­ing qual­ity as­sur­ance sys­tem and that the com­pany man­age­ment and staff in the in­di­vidu­al de­part­ments con­cerned take an act­ive part in this sys­tem;

b.

a Re­spons­ible Per­son in ac­cord­ance with Art­icle 26 is avail­able;

c.

the fa­cil­it­ies are or­gan­ised in an ap­pro­pri­ate way;

d.

a doc­u­ment­a­tion sys­tem is avail­able that com­prises the work­ing in­struc­tions, pro­cess de­scrip­tions and pro­to­cols of the rel­ev­ant pro­ced­ures;

e.

due di­li­gence is ex­er­cised as de­scribed in Art­icle 25.

²Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.

³ The li­cence does not en­title the hold­er to is­sue man­u­fac­tur­ing or­ders.

¹ Hold­ers of a li­cence in ac­cord­ance with Art­icle 24 must en­sure that the sup­pli­er and the cus­tom­er are au­thor­ised to carry out the work pro­cesses that they per­form. They must be able to prove this.

² They must en­sure that the medi­cin­al products have not ori­gin­ated from il­leg­al trad­ing and are not in­ten­ded for un­law­ful pur­poses.

³ They must for­ward to the cus­tom­er or the sup­pli­er all in­form­a­tion provided by any sup­pli­er or cus­tom­er re­gard­ing the qual­ity and safety of the medi­cin­al product or that is rel­ev­ant for the au­thor­it­ies, in par­tic­u­lar in­form­a­tion about medi­cin­al product re­calls.

⁴ The agents must ad­di­tion­ally re­tain cop­ies of the pa­per­work doc­u­ment­ing the busi­ness trans­ac­tion.

¹ Re­spons­ible Per­sons carry out the dir­ect tech­nic­al su­per­vi­sion of the fa­cil­it­ies and in par­tic­u­lar en­sure com­pli­ance with due di­li­gence with­in the fa­cil­it­ies.

² They are au­thor­ised to is­sue in­struc­tions with­in their sphere of activ­ity.

³ They en­sure their dep­u­tisa­tion by ad­equately qual­i­fied spe­cial­ists.

⁴ If the fa­cil­ity ceases op­er­a­tions, or if op­er­a­tions can be ex­pec­ted to cease im­min­ently, they must re­port this situ­ation to Swiss­med­ic without delay.

⁵ They must have the ne­ces­sary train­ing, ex­pert­ise and ex­per­i­ence, and be trust­worthy.

⁶ They de­cide in­de­pend­ently of the com­pany’s man­age­ment and may not sit on any of the fa­cil­it­ies’ su­per­vis­ory com­mit­tees. Swiss­med­ic may grant a li­cence to small fa­cil­it­ies without such se­greg­a­tion if they can­not im­ple­ment the se­greg­a­tion be­cause of their size.

⁷ If the size and nature of the fa­cil­it­ies per­mit this activ­ity to be per­formed on a part-time basis, re­spons­ib­il­it­ies must be spe­cified in writ­ing and the min­im­um num­ber of hours dur­ing which the Re­spons­ible Per­son must be present in the fa­cil­ity must be de­term­ined.

⁸ Swiss­med­ic may spe­cify fur­ther de­tails, in par­tic­u­lar the min­im­um num­ber of hours dur­ing which the Re­spons­ible Per­son must be present in the fa­cil­ity and the re­quire­ments that they must ful­fil in terms of train­ing and ex­per­i­ence.

¹ Any per­son ap­ply­ing for a li­cence to col­lect blood for trans­fu­sion or the man­u­fac­ture of medi­cin­al products in ac­cord­ance with Art­icle 34 TPA must prove that:

a.

the con­di­tions de­scribed in Art­icle 3 have been ful­filled;

b.

the Re­spons­ible Per­son ful­fils the con­di­tions of Art­icles 5 and 6 and has a uni­versity de­gree in medi­cine or a life sci­ence and the sci­entif­ic and med­ic­al ex­per­i­ence needed to col­lect blood;

c.

blood is col­lec­ted in com­pli­ance with the GMP rules de­scribed in An­nex 1;

d.

due di­li­gence is ex­er­cised as de­scribed in Art­icles 28–38.

² Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.

¹ The hold­er of a li­cence for activ­it­ies with blood or labile blood products must ap­point a per­son re­spons­ible for hae­movi­gil­ance.

² The Re­spons­ible Per­son must be a doc­tor and have the ap­pro­pri­ate tech­nic­al know­ledge.

³ This per­son has an ob­lig­a­tion to re­port ad­verse drug re­ac­tions in ac­cord­ance with Art­icles 61 and 65 TPO⁸.

⁴ Swiss­med­ic may also re­cog­nise per­sons with oth­er pro­fes­sion­al qual­i­fic­a­tions as Re­spons­ible Per­sons, provided they pos­sess suf­fi­cient know­ledge and ex­per­i­ence.

⁵ While Re­spons­ible Per­sons do not need to be em­ploy­ees of the com­pany, their re­spons­ib­il­it­ies must in all cases be defined in writ­ing.

¹ The suit­ab­il­ity of blood donors must be eval­u­ated by a qual­i­fied phys­i­cian with ex­per­i­ence in trans­fu­sion medi­cine or by a per­son trained in this as­sess­ment who is work­ing un­der the su­per­vi­sion of a qual­i­fied phys­i­cian.

² The donors must be provided with com­pre­hens­ive in­form­a­tion about donat­ing blood and the risks of in­fec­tion with ma­jor patho­gens must be ex­plained be­fore the blood dona­tion so that they can de­cide not to donate blood if the blood they donate could rep­res­ent a risk of in­fec­tion for third parties.

³ Oth­er­wise, the in­form­a­tion provided in the con­text of a dona­tion is guided by An­nex 5 num­ber 3.

⁴ Per­sons in the fol­low­ing cat­egor­ies are not per­mit­ted to donate blood:

a.

those who have been dia­gnosed with HIV;

b.

those who are suf­fer­ing from AIDS or who have symp­toms in­dic­at­ive of an AIDS-re­lated ill­ness;

c.

those whose be­ha­viour car­ries the risk of in­fec­tion with HIV;

d.

in­tim­ate part­ners of per­sons de­scribed un­der let­ters a–c;

e.

those who carry a spe­cif­ic risk of pri­on in­fec­tion;

f.

those who have re­ceived trans­plant ma­ter­i­al of an­im­al ori­gin.

⁵ Oth­er­wise, donor suit­ab­il­ity is eval­u­ated in ac­cord­ance with An­nex 5 num­ber 1.

¹ A sample of every col­lec­ted blood dona­tion used for trans­fu­sion or to man­u­fac­ture labile blood products must be tested in ac­cord­ance with the test­ing re­quire­ments lis­ted in An­nex 5 num­ber 2.

² The tests must be per­formed us­ing ap­pro­pri­ate meth­ods or pro­ced­ures that are val­id­ated in ac­cord­ance with the state-of-the-art sci­entif­ic and tech­nic­al know­ledge and are suit­able for test­ing donated blood and plasma.

³ Be­fore blood or eryth­ro­cyte pre­par­a­tions are trans­fused, their com­pat­ib­il­ity with the re­cip­i­ent's blood must be es­tab­lished us­ing ap­pro­pri­ate meth­ods.

¹ If the tests are car­ried out abroad, it must be proven that they com­ply with the state-of-the-art sci­entif­ic and tech­no­lo­gic­al know­ledge.

² Swiss­med­ic may spe­cify tech­nic­al re­quire­ments and par­tic­u­lars in re­la­tion to the tests and test pro­ced­ures.

³ When tests are be­ing car­ried out on blood or labile blood products in­ten­ded for trans­fu­sion or to man­u­fac­ture medi­cin­al products, the rules of good prac­tice must be ad­hered to in ac­cord­ance with An­nex 1 of the Or­din­ance of 29 April 2015⁹ on Mi­cro­bi­o­lo­gic­al Labor­at­or­ies.

¹ If the test is re­peatedly re­act­ive, the blood dona­tion may not be used for trans­fu­sion or to man­u­fac­ture blood products.

² If fur­ther con­firm­a­tion tests on blood in­ten­ded for auto­log­ous trans­fu­sion give a neg­at­ive res­ult or if the res­ults of tests car­ried out in ac­cord­ance with An­nex 5, num­ber 2.2 let­ter d de­vi­ate from the norm, the treat­ing phys­i­cian de­cides wheth­er to carry out the trans­fu­sion.

¹ The donor may only be in­formed of a pos­it­ive test res­ult if the test has been con­firmed us­ing an ap­pro­pri­ate meth­od.

² Where a donor is in­formed of a pos­it­ive test res­ult, they must also be offered coun­selling and as­sist­ance.

³ The donor may re­fuse to be in­formed of a test res­ult.

¹ Blood and labile blood products and the cor­res­pond­ing blood samples must be la­belled in ac­cord­ance with the rules of GMP and good prac­tice in ac­cord­ance with An­nex 1 of the Or­din­ance of 29 April 2015¹⁰ on Mi­cro­bi­o­lo­gic­al Labor­at­or­ies.

² In the case of auto­log­ous trans­fu­sion, the la­bel must also bear the name of the donor and the la­bel must be signed by the auto­log­ous donor im­me­di­ately be­fore blood col­lec­tion.

³ Auto­log­ous dona­tions must be kept sep­ar­ate from ho­mo­log­ous dona­tions.

¹ Hold­ers of a li­cence for hand­ling blood and labile blood products must main­tain re­cords of all safety-rel­ev­ant activ­it­ies, in par­tic­u­lar in re­la­tion to the col­lec­tion of blood, and the man­u­fac­ture, re­lease, dis­tri­bu­tion, de­struc­tion and re­call of blood or labile blood products.

² They must en­sure that blood or labile blood products can be traced back to the donor. For this pur­pose, each blood dona­tion must be giv­en a donor num­ber that makes it pos­sible at any time to clearly identi­fy the dona­tion, the donor's med­ic­al his­tory, every blood product made from his dona­tion and all doc­u­ments re­lated to these products.

³ Whenev­er blood is donated, the fol­low­ing in­form­a­tion must be re­cor­ded in de­tail:

a.

the date and iden­ti­fic­a­tion of the dona­tion and the donor;

b.

in­form­a­tion on the de­cision on donor suit­ab­il­ity and, if rel­ev­ant, the reas­on for ex­clud­ing a donor;

c.

the test res­ults and their in­ter­pret­a­tion.

⁴ Each pro­tocol must be signed by a per­son who is au­thor­ised to do so by the qual­ity man­age­ment sys­tem.

¹ If the hold­er of a li­cence to handle blood and labile blood products ceases this activ­ity pri­or to ex­piry of the archiv­ing ob­lig­a­tion in ac­cord­ance with Art­icle 40 TPA, the archives must be handed over to Swiss­med­ic, or to the Blood Trans­fu­sion Ser­vice of the Swiss Red Cross if it is one of its es­tab­lish­ments.

² Swiss­med­ic or the Blood Trans­fu­sion Ser­vice of the Swiss Red Cross des­troys the archives on ex­piry of the archiv­ing ob­lig­a­tion.

¹ Hold­ers of a li­cence to handle blood or labile blood products must im­me­di­ately take the ne­ces­sary pro­tect­ive meas­ures if they no­tice that:

a.

at the time of dona­tion the donor did not ful­fil the cri­ter­ia re­quired to be con­sidered a suit­able donor;

b.

the tests for trans­mit­table dis­eases have not been car­ried out in ac­cord­ance with the reg­u­la­tions;

c.

the donor has un­der­gone sero­con­ver­sion or has con­trac­ted a blood-borne in­fec­tion;

d.

the re­cip­i­ent of a dona­tion de­vel­ops a post-trans­fu­sion in­fec­tion which could be traced back to the donor;

e.

ser­i­ous de­fects in re­la­tion to the GMP rules de­scribed in An­nex 1 have oc­curred dur­ing the blood col­lec­tion pro­cess or the man­u­fac­tur­ing of labile blood products.

² The meas­ures that will be taken if the situ­ations de­scribed in para­graph 1 let­ters b–e oc­cur must be re­por­ted to Swiss­med­ic.

³ Meas­ures taken in the event of oc­cur­rences de­scribed in para­graph 1 let­ters c and d may in­volve in­vest­ig­a­tions in­to pre­vi­ous dona­tions or oth­er donors.

⁴ In­sti­tu­tions which use blood and labile blood products in pa­tients must in­form the man­u­fac­tur­ers on re­quest of the rel­ev­ant in­form­a­tion about use of the labile blood product and about the con­clu­sion of the tra­cing pro­ced­ure if in­vest­ig­a­tions as de­scribed in para­graph 3 are car­ried out.

¹ Blood and labile blood products may only be used for ho­mo­log­ous trans­fu­sions if the leu­co­cytes have been de­pleted in a val­id­ated state-of-the-art sci­entif­ic or tech­nic­al pro­ced­ure.

² Plasma may only be used for ho­mo­log­ous trans­fu­sions if, in ad­di­tion to the safety meas­ure de­scribed in para­graph 1 and the tests de­scribed in Art­icle 30:

a.

it has been stored for four months and on ex­piry of the dead­line a new test on the donor pro­duced a neg­at­ive res­ult; or

b.

it has un­der­gone a pro­ced­ure to in­ac­tiv­ate or elim­in­ate vir­uses.

³ Plate­let con­cen­trates may only be used in Switzer­land if ap­pro­pri­ate meas­ures are taken to mit­ig­ate the risk of bac­teri­al con­tam­in­a­tion.

⁴ Un­used auto­log­ous dona­tions must not be used for ho­mo­log­ous trans­fu­sions or to man­u­fac­ture blood products.

¹ The li­cence is gran­ted if:

a.

the ap­plic­a­tion is com­plete;

b.

the ap­plic­ant ful­fils all rel­ev­ant con­di­tions at all fa­cil­it­ies for the activ­it­ies ap­plied for.

² Swiss­med­ic shall sus­pend the sub­stant­ive as­sess­ment of the ap­plic­a­tion if crim­in­al pro­ceed­ings are pending against a Re­spons­ible Per­son in ac­cord­ance with Art­icles 5, 6, 17, 18, 23 or 26, as a res­ult of which Swiss­med­ic con­cludes that the con­di­tions for ad­equate tech­nic­al su­per­vi­sion are no longer ful­filled.

³ If a Re­spons­ible Per­son is un­der in­vest­ig­a­tion for in­fringing the TPA or the Nar­cot­ics Act of 3 Oc­to­ber 1951¹¹ in crim­in­al pro­ceed­ings, Swiss­med­ic may sus­pend the cor­res­pond­ing li­cence.

⁴ It may de­mand a stand­ard private ex­tract from the VOSTRA in­form­a­tion sys­tem of the Re­gister of Crim­in­al Re­cords or an ex­tract from a for­eign crim­in­al re­cords re­gister.¹²

⁵ The ap­plic­ant is gran­ted a single li­cence for all activ­it­ies in the ap­plic­a­tion in ac­cord­ance with the TPA and this Or­din­ance.

The li­cence spe­cifies the name of the Re­spons­ible Per­son, the li­censed activ­it­ies and the site of the fa­cil­it­ies. It may not be trans­ferred to oth­er per­sons or to oth­er sites.

¹ Hold­ers of a li­cence must ap­ply to Swiss­med­ic with the ne­ces­sary doc­u­ment­a­tion for any amend­ments to the con­tent of the li­cence.

² They must re­port the es­sen­tial de­tails of all ma­jor changes to fa­cil­it­ies, equip­ment or pro­ced­ures used in the man­u­fac­ture, test­ing or im­port and ex­port of medi­cin­al products, for whole­sale trad­ing or in trad­ing abroad with medi­cin­al products or for broker­age or agency activ­it­ies in con­nec­tion with medi­cin­al products and which could in­flu­ence qual­ity.

³ Swiss­med­ic shall re­spond to ap­plic­a­tions un­der para­graph 1 and make any ob­jec­tions to amend­ments as in para­graph 2 with­in a peri­od of 30 days.

¹ Ful­fil­ment of all the con­di­tions for re­tain­ing the li­cence is re­viewed peri­od­ic­ally by in­spec­tion.

² If the con­di­tions are no longer ful­filled or if their ful­fil­ment can­not be ex­amined, spe­cific­ally be­cause the li­censed activ­it­ies have not been per­formed for more than twelve months, Swiss­med­ic may re­voke the li­cence either wholly or in part.

Swiss­med­ic may spe­cify the terms of the li­cens­ing pro­ced­ure in great­er de­tail.

¹ Any per­son who im­ports the fol­low­ing medi­cin­al products that are au­thor­ised or not sub­ject to au­thor­isa­tion or blood and blood products in­to Switzer­land re­quires a li­cence for each ship­ment:

a.

im­mun­o­lo­gic­al medi­cin­al products;

b.

blood and blood products.

² A li­cence is not re­quired for the im­port of in­di­vidu­al batches of:

a.

al­ler­gens;

b.

blood that is au­thor­ised or not sub­ject to au­thor­isa­tion and blood products of this kind if these medi­cin­al products:

1.

are im­por­ted in med­ic­al emer­gen­cies or for auto­log­ous trans­fu­sion,

2.

are not in­ten­ded for use in hu­mans, or

3.

have an of­fi­cial batch re­lease from one of the con­trol au­thor­it­ies be­long­ing to the Of­fi­cial Con­trol Au­thor­ity Batch Re­lease Net­work (OCABR Net­work);

c.

im­mun­o­lo­gic­al medi­cin­al products that are au­thor­ised or not sub­ject to au­thor­isa­tion provided an of­fi­cial batch re­lease from one of the con­trol au­thor­it­ies be­long­ing to the OCABR Net­work is avail­able for the batch to be im­por­ted.

³ In the in­terest of pro­tect­ing health, Swiss­med­ic may im­pose tem­por­ary or per­man­ent man­dat­ory li­cens­ing on the im­port of in­di­vidu­al batches of im­mun­o­lo­gic­al medi­cin­al products or of blood and blood products that are au­thor­ised or not sub­ject to au­thor­isa­tion even if an of­fi­cial batch re­lease as de­scribed in para­graph 2 let­ter b num­ber 3 is avail­able.

Any per­son ap­ply­ing for a li­cence in ac­cord­ance with Art­icle 44 para­graph 1 must prove that:

a.

they have a li­cence to im­port medi­cin­al products;

b.

if these are ready-to-use medi­cin­al products destined for the Swiss mar­ket, they have the cor­res­pond­ing au­thor­isa­tion;

c.

they en­sure the safe and law­ful im­port of the medi­cin­al products and ac­cept re­spons­ib­il­ity for this;

d.

the man­u­fac­tur­ing and im­port of the medi­cin­al products and whole­sale trad­ing in medi­cin­al products are in con­form­ity with the GMP rules de­scribed in An­nex 1 and the GDP rules de­scribed in An­nex 4;

e.

in the case of blood and blood products for use in hu­mans, in ad­di­tion to let­ters a–d:

1.

no patho­gens or in­dic­a­tion of the pres­ence of patho­gens can be de­tec­ted,

2.

each in­di­vidu­al blood dona­tion is ana­lysed us­ing tests that cor­res­pond to state-of-the-art sci­entif­ic and tech­nic­al know­ledge,

3.

blood and plasma are only im­por­ted un­mixed, un­less Swiss­med­ic has ex­cep­tion­ally gran­ted a li­cence to im­port mixed products,

4.

the re­quire­ments in ac­cord­ance with Art­icle 27 para­graph 1 let­ter c and Art­icles 34, 35 and 37 are ad­hered to.

¹ The ap­plic­a­tion for a li­cence to im­port in­di­vidu­al batches must be sub­mit­ted to Swiss­med­ic to­geth­er with the ne­ces­sary doc­u­ment­a­tion.

² The li­cence is val­id for one month.

³ The ap­plic­ant must en­sure that the li­cence is presen­ted to the cus­toms of­fice at the time when the medi­cin­al products are im­por­ted.

⁴ On cus­toms clear­ance, the cus­toms of­fice shall dis­charge the li­cence and for­ward it to Swiss­med­ic.

⁵ In the ab­sence of a li­cence to im­port in­di­vidu­al batches in ac­cord­ance with Art­icle 44 para­graph 1, medi­cin­al products are re­fused entry at the bor­der and re­por­ted to Swiss­med­ic.

In­di­vidu­als may im­port ready-to-use medi­cin­al products that are not au­thor­ised in Switzer­land in quant­it­ies needed for their per­son­al use. This does not ap­ply to:

a.

medi­cin­al products which con­tain ge­net­ic­ally mod­i­fied or­gan­isms,

b.

im­mun­o­lo­gic­al medi­cin­al products for use in live­stock;

c.

vac­cines, tox­ins and sera for veter­in­ary us­age;

d.

trans­plant products with­in the mean­ing of the Trans­plant­a­tion Or­din­ance of 16 March 2007¹⁴ which have been ge­net­ic­ally mod­i­fied.

¹ A med­ic­al pro­fes­sion­al who has a can­ton­al dis­pens­ing li­cence may im­port small quant­it­ies of a ready-to-use hu­man medi­cin­al product that is not au­thor­ised in Switzer­land provided:

a.

the medi­cin­al product is in­ten­ded for a spe­cif­ic pa­tient or for emer­gen­cies;

b.

the medi­cin­al product has been au­thor­ised by a coun­try with a com­par­able reg­u­lat­ory sys­tem; and

c.

for the medi­cin­al product con­cerned:

1.

no al­tern­at­ively us­able medi­cin­al product is au­thor­ised in Switzer­land,

2.

an al­tern­at­ively us­able medi­cin­al product is au­thor­ised in Switzer­land, but is not avail­able on the Swiss mar­ket, or

3.

it is not ap­pro­pri­ate to switch the med­ic­a­tion to a medi­cin­al product au­thor­ised and avail­able in Switzer­land.

² Treat­ing phys­i­cians with a can­ton­al pro­fes­sion­al li­cence may im­port small quant­it­ies of ready-to-use hu­man medi­cin­al products that are not au­thor­ised in Switzer­land if:

a.

they have per­formed a risk ana­lys­is to con­firm the ap­pro­pri­ate­ness of the us­age and no­ti­fied the com­pet­ent can­ton­al au­thor­it­ies of their con­clu­sions be­fore the medi­cin­al products are im­por­ted; and

b.

the medi­cin­al product:

1.

ful­fils the con­di­tions de­scribed in para­graph 1 let­ters a and c, and

2.

has been au­thor­ised by a coun­try with a com­par­able reg­u­lat­ory sys­tem for use in a clin­ic­al tri­al.

³ Phar­macists with phar­ma­ceut­ic­al re­spons­ib­il­ity in a hos­pit­al phar­macy may im­port small quant­it­ies of ready-to-use hu­man medi­cin­al products to sup­ply their own cus­tom­ers if the con­di­tions in para­graph 1 let­ters b and c or the con­di­tions in para­graph 1 let­ter c and 2 let­ters a and b are ful­filled.

⁴ Med­ic­al pro­fes­sion­als as de­scribed in Art­icle 25 para­graph 1 let­ters b and c TPA who have a can­ton­al pro­fes­sion­al li­cence may im­port small quant­it­ies of non-pre­scrip­tion ready-to-use hu­man medi­cin­al products that are not au­thor­ised in Switzer­land un­der the terms of their dis­pens­ing li­cence provided the con­di­tions in para­graph 1 are ful­filled.

⁵ Pri­or to im­port, im­port­ing per­sons must check in each case wheth­er the rel­ev­ant re­quire­ments in para­graphs 1–4 are met and en­sure that the medi­cin­al products are trans­por­ted in con­form­ity with the GDP rules de­scribed in An­nex 4.

⁶ They must keep a re­cord of the check de­scribed in para­graph 5 and of the time when the check was car­ried out and the im­port took place, and the nature, num­ber and in­ten­ded use of the im­por­ted hu­man medi­cin­al products.

⁷ The im­port of medi­cin­al products for an­im­als by veter­in­ari­ans is sub­ject to Art­icles 7‒7d of the Veter­in­ary Medi­cin­al Products Or­din­ance of 18 Au­gust 2004¹⁵.¹⁶

In­so­far as in­ter­gov­ern­ment­al or­gan­isa­tions and in­ter­na­tion­al in­sti­tu­tions are en­titled un­der an agree­ment with Switzer­land con­cern­ing priv­ileges, im­munit­ies and fa­cil­it­ies, to im­port items for their of­fi­cial use, they may im­port a ready-to-use hu­man medi­cin­al product that is not au­thor­ised in Switzer­land in the quant­it­ies re­quired to for of­fi­cial activ­it­ies and to main­tain op­er­a­tions, provided that the medi­cin­al product:

a.

is im­por­ted un­der the su­per­vi­sion of a phys­i­cian in the med­ic­al ser­vice of the or­gan­isa­tion or in­sti­tu­tion;

b.

is in­ten­ded ex­clus­ively for of­fi­cial use with­in the or­gan­isa­tion or in­sti­tu­tion and

c.

is au­thor­ised in a coun­try with com­par­able reg­u­lat­ory sys­tem or has been au­thor­ised by the World Health Or­gan­iz­a­tion un­der its emer­gency pro­ced­ure.

¹ Any per­son who ex­ports medi­cin­al products that can be used for cap­it­al pun­ish­ment re­quires a li­cence from Swiss­med­ic for each trans­ac­tion.

² Any per­son who trades abroad in such medi­cin­al products re­quires a li­cence from Swiss­med­ic for each trans­ac­tion.

³ A li­cence as de­scribed in para­graphs 1 and 2 may be gran­ted provided the ap­plic­ant:

a.

con­firms to Swiss­med­ic that, fol­low­ing in­vest­ig­a­tions, there is no evid­ence that the medi­cin­al products in ques­tion will be used for cap­it­al pun­ish­ment; and

b.

sub­mits a de­clar­a­tion by the cus­tom­er stat­ing that the medi­cin­al products will not be used by the cus­tom­er or by third parties for cap­it­al pun­ish­ment.

⁴ Swiss­med­ic pub­lishes a list of medi­cin­al products that can be used for cap­it­al pun­ish­ment It takes in­to ac­count val­id EU law, in par­tic­u­lar the del­eg­ated acts and im­ple­ment­ing acts ad­op­ted by the European Com­mis­sion on the basis of Coun­cil Reg­u­la­tion (EC) No 1236/2005¹⁸.

The trans­it of medi­cin­al products which are dan­ger­ous to health is not per­mit­ted.

¹ A tem­por­ary li­cence to use medi­cin­al products in ac­cord­ance with Art­icle 9b para­graph 1 TPA may be gran­ted to the spon­sor of a clin­ic­al tri­al ap­proved in Switzer­land if the spon­sor:

a.

con­firms that the medi­cin­al product is identic­al to the medi­cin­al product used in at least one clin­ic­al tri­al ap­proved in Switzer­land;

b.

jus­ti­fies every de­vi­ation from the most re­cently ap­proved pro­tocol and spe­cifies the con­di­tions un­der which the medi­cin­al product will be used;

c.

jus­ti­fies the non-in­clu­sion of pa­tients in the clin­ic­al tri­al;

d.

states the reas­ons why use is likely to be of ma­jor thera­peut­ic be­ne­fit;

e.

proves that there is no al­tern­at­ive and equi­val­ent medi­cin­al product au­thor­ised in Switzer­land;

f.

pro­poses and jus­ti­fies a peri­od of valid­ity for the li­cence;

g.

states and jus­ti­fies the treat­ment centres and the pro­posed num­ber of pa­tients;

h.

sub­mits a draft of the in­form­a­tion provided for pa­tients; and

i.

has ob­tained a pre­lim­in­ary opin­ion on let­ters b–h from the Eth­ics Com­mit­tee which ap­proved the ref­er­ence tri­al or, in the case of a mul­ti­centre clin­ic­al tri­al, from the lead Eth­ics Com­mit­tee.

² If the ap­plic­a­tion con­cerns the use of a medi­cin­al product which has been tested in pa­tients with good res­ults in a clin­ic­al tri­al, it must be used in ac­cord­ance with the pro­tocol for that clin­ic­al tri­al. The con­di­tions set out in para­graph 1 let­ters a and d–i must be ful­filled.

³ This li­cence also cov­ers the im­port of the medi­cin­al products con­cerned, in­clud­ing the in­di­vidu­al im­port of im­mun­o­lo­gic­al medi­cin­al products, blood and blood products.

¹ The ap­plic­a­tion is sub­mit­ted to Swiss­med­ic with the doc­u­ments lis­ted in An­nex 6.

² Swiss­med­ic may re­quest ad­di­tion­al in­form­a­tion.

³ It in­forms the Eth­ics Com­mit­tee about its de­cision and, where ap­pro­pri­ate, any sub­sequent de­cisions.

¹ The spon­sor no­ti­fies Swiss­med­ic of all ma­jor changes af­fect­ing the medi­cin­al product or its us­age by ana­logy with Art­icle 34 para­graph 3 let­ters a‑c of the Or­din­ance of 20 Septem­ber 2013¹⁹ on Clin­ic­al Tri­als.²⁰

² The spon­sor no­ti­fies Swiss­med­ic of all ad­verse re­ac­tions and events in ac­cord­ance with Art­icle 59 TPA.

³ The spon­sor sends Swiss­med­ic a safety re­port once a year.

¹ Swiss­med­ic may with­draw the li­cence in the in­terest of pro­tect­ing pa­tients’ health.

² The an­nounce­ment of a fi­nal Swiss­med­ic de­cision re­ject­ing the ap­plic­a­tion for a li­cence to place the medi­cin­al product on the mar­ket leads to with­draw­al of the li­cence.

³ If Swiss­med­ic au­thor­ises the mar­ket­ing of the medi­cin­al product, the tem­por­ary li­cence to use the product ends when the medi­cin­al product is ac­tu­ally sup­plied. The spon­sor in­forms Swiss­med­ic of the time at which the medi­cin­al product is ac­tu­ally sup­plied.

In­spect­or­ates that con­duct in­spec­tions by vir­tue of this Or­din­ance must have a qual­ity man­age­ment sys­tem that com­plies with in­ter­na­tion­ally re­cog­nised stand­ards and must be ac­cred­ited.

¹ In­spect­ors must have an ap­pro­pri­ate uni­versity de­gree in the rel­ev­ant field or a com­par­able qual­i­fic­a­tion, to­geth­er with ex­per­i­ence and reg­u­lar train­ing.

² They must be in­de­pend­ent of the com­pan­ies that they are in charge of in­spect­ing. If this is not the case, they must re­cuse them­selves.

The can­tons must no­ti­fy Swiss­med­ic of any changes with­in their in­spect­or­ates.

¹ The com­pet­ent au­thor­ity may at any time or­der in­spec­tions in Switzer­land or carry them out them­selves whenev­er they con­sider this ne­ces­sary.

² Swiss­med­ic may in­spect man­u­fac­tur­ers of medi­cin­al product abroad and fa­cil­it­ies abroad that en­gage in whole­sale trad­ing in medi­cin­al products, at the im­port­ing com­pany’s ex­pense. It in­forms this com­pany in ad­vance.

³ In those States with which Switzer­land has signed an agree­ment for the mu­tu­al re­cog­ni­tion of GMP sys­tems, Swiss­med­ic only car­ries out in­spec­tions in jus­ti­fied ex­cep­tion­al cases and after con­sulta­tion with the com­pet­ent health­care au­thor­it­ies in that State.

At the re­quest of fa­cil­it­ies in­spec­ted in Switzer­land or abroad in ac­cord­ance with Art­icle 60, Swiss­med­ic may con­firm by means of a cer­ti­fic­ate that the fa­cil­it­ies are in con­form­ity with the stand­ards of good prac­tice re­cog­nised in Switzer­land.

The in­spect­ors may:

a.

de­mand a cur­rent de­scrip­tion of the fa­cil­it­ies in the form of a Site Mas­ter File from the com­pany to be in­spec­ted;

b.

enter any part of a com­pany's fa­cil­it­ies with or without pri­or no­ti­fic­a­tion and, if re­quired, take pho­to­graphs;

c.

make cop­ies of doc­u­ments, in­clud­ing data saved on elec­tron­ic data stor­age me­dia or in part of a com­puter sys­tem;

d.

take samples of medi­cin­al products, raw ma­ter­i­als, in­ter­me­di­ate products, pack­aging ma­ter­i­al or ma­ter­i­als used in the man­u­fac­tur­ing pro­cess; and

e.

take all ne­ces­sary im­me­di­ate meas­ures.

After con­sulta­tion with the in­spect­ors ap­poin­ted by the can­tons, Swiss­med­ic is­sues guidelines to guar­an­tee uni­form in­spec­tion pro­ced­ures throughout Switzer­land.

¹ Swiss­med­ic and the can­ton­al au­thor­it­ies col­lab­or­ate in their con­trol work and may in par­tic­u­lar ex­change con­fid­en­tial in­form­a­tion.

² They no­ti­fy each oth­er about:

a.

the grant­ing, amend­ment, sus­pen­sion or with­draw­al of a li­cence;

b.

meas­ures taken;

c.

in­spec­tions.

³ The can­ton­al au­thor­it­ies provide Swiss­med­ic with any in­form­a­tion brought to their at­ten­tion that in­dic­ates qual­ity or safety de­fects.

⁴ Swiss­med­ic may as­sist the can­ton­al in­spect­or­ates in train­ing their in­spect­ors.

¹ Cus­toms clear­ance for im­ports, ex­ports and goods in trans­it is gov­erned by cus­toms le­gis­la­tion.

² The cus­toms au­thor­it­ies provide Swiss­med­ic with in­form­a­tion on the im­port, ex­port and trans­it of medi­cin­al products.

³ Swiss­med­ic may re­quire the cus­toms au­thor­it­ies to de­tain medi­cin­al products for fur­ther in­spec­tion and take samples.

The or­gans re­spons­ible for en­force­ment are au­thor­ised to pro­cess the per­son­al data that they re­quire for per­form­ing all the tasks as­signed to them by this Or­din­ance. These data in­clude:

a.

health data re­cor­ded in con­nec­tion with the of­fi­cial mar­ket sur­veil­lance of blood and blood products (Art. 39, 58 and 59 TPA);

b.²¹

data on ad­min­is­trat­ive and crim­in­al pro­ceed­ings or sanc­tions that are rel­ev­ant to the as­sess­ment of li­cence ap­plic­a­tions, spe­cific­ally in as­sess­ing wheth­er a re­spons­ible per­son is ap­pro­pri­ate for this task.

¹ Swiss­med­ic is re­spons­ible for the se­cure op­er­a­tion of its in­form­a­tion sys­tems and the law­ful­ness of its data pro­cessing.

² It is­sues a pro­cessing policy for each in­form­a­tion sys­tem. In this policy, it es­tab­lishes the tech­nic­al and or­gan­isa­tion­al meas­ures used to en­sure the se­cur­ity and pro­tec­tion of the pro­cessed data.

³ If it trans­fers activ­it­ies to third parties, it en­sures com­pli­ance with data se­cur­ity re­quire­ments by means of a con­tract.

¹ Em­ploy­ees of Swiss­med­ic have on­line ac­cess to the in­form­a­tion sys­tems to the ex­tent ne­ces­sary for them to per­form their tasks.

² Ac­cess to the in­form­a­tion sys­tems shall be logged. Such logs shall be kept for no longer than two years and sep­ar­ate from the sys­tem in which the per­son­al data is pro­cessed.²²

Swiss­med­ic re­tains per­son­al data in its in­form­a­tion sys­tems for no longer than ten years. The data are de­leted as soon as they are no longer re­quired to per­form a task.

Swiss­med­ic reg­u­larly pub­lishes lists with the in­form­a­tion spe­cified in An­nex 7.

¹ The Fed­er­al De­part­ment of Home Af­fairs may ad­apt the an­nexes to this Or­din­ance to take ac­count of in­ter­na­tion­al or tech­nic­al de­vel­op­ments.

² Amend­ments that could con­sti­tute tech­nic­al bar­ri­ers to trade are made in agree­ment with the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search.

The re­peal and amend­ment of oth­er le­gis­la­tion are covered in An­nex 8.

¹ Li­cences gran­ted un­der the pre­vi­ous law re­tain their valid­ity no longer than the date on which they ex­pire. The ap­plic­a­tion to re­new a li­cence must be sub­mit­ted spon­tan­eously to Swiss­med­ic with the ne­ces­sary doc­u­ment­a­tion at least six months be­fore ex­piry of the li­cence. Amend­ments to such li­cences must be re­ques­ted as part of a re­new­al ap­plic­a­tion.

² Ap­plic­a­tions for broker­age and agency li­cences must be sub­mit­ted to Swiss­med­ic no later than 30 June 2019. Activ­it­ies may be con­tin­ued un­til Swiss­med­ic reaches a de­cision.

³ Ap­plic­a­tions for li­cences that were sub­mit­ted be­fore 1 Janu­ary 2019 will be as­sessed and gran­ted in ac­cord­ance with pre­vi­ous law.

¹ This Or­din­ance comes in­to force on 1 Janu­ary 2019 sub­ject to para­graph 2.

² Art­icle 20 para­graphs 2–4 come in­to force on 1 Janu­ary 2020.