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Reproductive Medicine Ordinance
(RMO)

of 4 December 2000 (Status as of 1 July 2022)

The Swiss Federal Council,

based on Articles 14 and 25 paragraph 3 of the Reproductive Medicine Act of 18 December 19981 (the Act),

ordains:

Chapter 1 Licensing

Section 1 Subject Matter

Art. 12  

A li­cence as spe­cified in Art­icle 8 para­graph 1 of the Act is re­quired by any per­son who, as hold­er of a can­ton­al pro­fes­sion­al prac­tising li­cence, in­de­pend­ently or as a team lead­er:

a.
uses as­sisted re­pro­duct­ive tech­niques;
b.
re­ceives re­pro­duct­ive cells, im­preg­nated ova or em­bry­os in vitro for pre­ser­va­tion or ar­ranges the sup­ply of donated sperm cells without per­son­ally us­ing as­sisted re­pro­duct­ive tech­niques.

2 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

Section 2 Licence Requirements

Art. 2 Evidence of qualifications for the use of assisted reproductive techniques 3  

1 Any per­son who uses as­sisted re­pro­duct­ive tech­niques re­quires:

the Swiss ob­stet­rics and gyn­ae­co­logy spe­cial­ist title with the gyn­ae­co­lo­gic­al en­do­crino­logy and re­pro­duct­ive medi­cine spe­cialty or an equi­val­ent re­cog­nised for­eign spe­cial­ist title; and

the can­ton­al li­cence to prac­tise as an in­de­pend­ent pro­fes­sion­al.

2 Any per­son who lim­its the activ­ity to in­sem­in­a­tion with sperm cells from a third party re­quires:

the Swiss ob­stet­rics and gyn­ae­co­logy spe­cial­ist title or an equi­val­ent re­cog­nised for­eign spe­cial­ist title; and

the can­ton­al li­cence to prac­tise as an in­de­pend­ent pro­fes­sion­al.

3 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

Art. 3 Evidence of qualifications to preserve and supply reproductive material 4  

Any per­son who re­ceives re­pro­duct­ive cells, im­preg­nated ova or em­bry­os in vitro for pre­ser­va­tion or ar­ranges the sup­ply of donated sperm cells without per­son­ally us­ing as­sisted re­pro­duct­ive tech­niques re­quires:

a Swiss or a re­cog­nised for­eign med­ic­al spe­cial­ist title; and

the can­ton­al li­cence to prac­tise as an in­de­pend­ent pro­fes­sion­al.

4 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

Art. 4 Reproductive medicine laboratory 5  

1 Any per­son who uses re­pro­duct­ive tech­niques re­quires a re­pro­duct­ive medi­cine labor­at­ory that meets the fol­low­ing re­quire­ments:

a.
It is man­aged by a per­son who:
1.
has com­pleted a uni­versity course of stud­ies in ac­cord­ance with the Med­ic­al Pro­fes­sions Act of 23 June 20066 or a mas­ters in the field of bio­logy or chem­istry from a tier-one uni­versity ac­cred­ited un­der the High­er Edu­ca­tion Act of 30 Septem­ber 20117 or a state-re­cog­nised or ac­cred­ited for­eign tier-one uni­versity;
2.
has re­ceived post­gradu­ate train­ing that the su­per­vis­ory au­thor­ity re­gards as suit­able; and
3.
is fa­mil­i­ar with the cur­rent state of the art as a res­ult of re­ceiv­ing suit­able con­tinu­ing pro­fes­sion­al train­ing.
b.
The staff have the re­quired pro­fes­sion­al skills and qual­i­fic­a­tions.
c.
The labor­at­ory op­er­ates a qual­ity man­age­ment sys­tem that is com­men­sur­ate with the pro­ced­ures offered and which is based on the stand­ards spe­cified in An­nex 2.

2 The Fed­er­al De­part­ment of Home Af­fairs may up­date An­nex 2 in line with in­ter­na­tion­al or tech­nic­al de­vel­op­ments. In con­sulta­tion with the Fed­er­al De­part­ment of Eco­nom­ic Af­fairs, Edu­ca­tion and Re­search, it shall make up­dates that may have the ef­fect of be­ing tech­nic­al bar­ri­ers to trade.

5 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

6 SR 811.11

7 SR 414.20

Art. 5 Use of donated sperm cells  

1 Any per­son wish­ing to use as­sisted re­pro­duct­ive tech­niques us­ing donated sperm cells must in­dic­ate in the ap­plic­a­tion:

a.
how donors are to be re­cruited and in­formed about the leg­al situ­ation (Art. 18 para. 2 of the Act);
b.
how health risks for the re­cip­i­ent are to be avoided.

2 Any per­son wish­ing to sup­ply donated sperm cells must in­dic­ate:

a.
what charge will be made to de­fray ex­penses;
b.
how it will be en­sured that data is duly re­cor­ded in ac­cord­ance with Art­icle 24 of the Act and Art­icle 17 of this Or­din­ance.

3 Any changes are to be no­ti­fied to the su­per­vis­ory au­thor­ity.

Art. 6 Counselling and care 8  

1 To­geth­er with the ap­plic­a­tion for a li­cence to use as­sisted re­pro­duct­ive tech­niques, plans must sub­mit­ted for the pro­vi­sion of so­cial psy­cho­lo­gic­al coun­selling and sup­port, as spe­cified in Art­icle 9 para­graph 2 let­ter c of the Act.

2 Where it is planned to use re­pro­duct­ive tech­niques with an ana­lys­is of the ge­net­ic ma­ter­i­al of re­pro­duct­ive cells or em­bry­os in vitro or with the se­lec­tion of donor sperm cells to pre­vent the trans­mis­sion of a ser­i­ous ill­ness, a pro­pos­al with re­gard to ge­net­ic coun­selling in ac­cord­ance with Art­icle 6a of the Act must be sub­mit­ted.

8 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

Art. 7 Information on scientific staff  

1 The per­son­al data and train­ing cer­ti­fic­ates of sci­entif­ic staff must be en­closed with the ap­plic­a­tion for a li­cence.

2 Any changes are to be no­ti­fied. The su­per­vis­ory au­thor­ity may provide for ex­cep­tions in the li­cence.

Section 3 Licensing and Supervision

Art. 8 Responsibility  

1 The body re­spons­ible for li­cens­ing and su­per­vi­sion shall be the de­part­ment re­spons­ible for health­care in the can­ton where the activ­ity spe­cified in Art­icle 8 para­graph 1 of the Act is car­ried out.

2 The can­tons may des­ig­nate an­oth­er au­thor­ity which has the ne­ces­sary ex­pert­ise.

Art. 9 Licensing  

1 The li­cence to use as­sisted re­pro­duct­ive tech­niques may be re­stric­ted to cer­tain tech­niques.

2 The li­cence may be gran­ted for a lim­ited term and sub­ject to con­di­tions.

3 ...9

9 Re­pealed by No I of the O of 21 June 2017, with ef­fect from 1 Sept. 2017 (AS 2017 3651).

Art. 10 Supervision 10  

1 With­in a year of grant­ing a li­cence, the su­per­vis­ory au­thor­ity shall ar­range for an in­spec­tion to be car­ried out by an ex­pert. There­after, an in­spec­tion shall be car­ried out as of­ten as ne­ces­sary, but at least once every three years.

2 The su­per­vis­ory au­thor­ity may con­sult an in­de­pend­ent ex­pert.

3 Per­sons charged with car­ry­ing out an in­spec­tion shall be gran­ted ac­cess at all times to the premises and fa­cil­it­ies used to per­form the activ­it­ies con­cerned.

3 If the labor­at­ory is ac­cred­ited un­der the Ac­cred­it­a­tion and Des­ig­na­tion Or­din­ance of 17 June 199611, the su­per­vis­ory au­thor­ity may dis­pense with all or part of the re­view of the qual­ity man­age­ment sys­tem.

4 The Swiss Ac­cred­it­a­tion Ser­vice shall no­ti­fy the su­per­vis­ory au­thor­ity with­in an ap­pro­pri­ate peri­od of ac­cred­it­a­tions that have been gran­ted or re­newed as well as of any that have been sus­pen­ded or re­voked.

10 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

11 SR 946.512

Art. 11 and 1212  

12 Re­pealed by No I of the O of 21 June 2017, with ef­fect from 1 Sept. 2017 (AS 2017 3651).

Art. 13 Expiry  

The li­cence shall ex­pire when the li­censed activ­it­ies are dis­con­tin­ued. Dis­con­tinu­ation of activ­it­ies is to be no­ti­fied to the su­per­vis­ory au­thor­ity.

Art. 14 Reporting  

1 Li­cence hold­ers must sub­mit an an­nu­al re­port on their activ­it­ies, as spe­cified in Art­icle 11 of the Act, to the su­per­vis­ory au­thor­ity by no later than 1 May of the fol­low­ing year.

2 The su­per­vis­ory au­thor­ity shall trans­mit the an­onymised data to the Fed­er­al Stat­ist­ic­al Of­fice by no later than 1 Ju­ly of the year in ques­tion for eval­u­ation and pub­lic­a­tion. The data must not in­clude any in­dic­a­tion of the centres of re­pro­duct­ive medi­cine.

3 The Fed­er­al Stat­ist­ic­al Of­fice shall provide the su­per­vis­ory au­thor­it­ies with a form for stand­ard­ised data col­lec­tion. This may also be used for the an­nu­al re­port on activ­it­ies re­ferred to in para­graph 1.

Art. 14a Evaluation 13  

The su­per­vis­ory au­thor­ity shall on re­quest send the Fed­er­al Of­fice of Pub­lic Health the data re­quired for the eval­u­ation in ac­cord­ance with Art­icle 14a para­graph 2 let­ter c of the Act to­geth­er with the con­tact de­tails for li­cence hold­ers in ac­cord­ance with Art­icle 8 para­graph 1 of the Act.

13 In­ser­ted by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

Chapter 2 Data on Biological Origins

Section 1 Donor Data Register 14

14 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

Art. 15 Competent authority 15  

1 The Fed­er­al Civil Status Of­fice (Fed­er­al Of­fice) shall keep a re­gister for stor­ing the sperm donor data spe­cified in Art­icle 24 of the Act (donor data re­gister).

2 The Fed­er­al Of­fice shall is­sue pro­cessing reg­u­la­tions gov­ern­ing the es­tab­lish­ment and man­age­ment of the donor data re­gister, and de­fin­ing in par­tic­u­lar the struc­ture, pro­ced­ures and ac­cess rights.

15 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

Art. 15a Online management 16  

1 The donor data re­gister is kept elec­tron­ic­ally.

2 The trans­mit­ted data are stored in elec­tron­ic form.

3 The elec­tron­ic sys­tem for the man­age­ment of the re­gister and for stor­ing the data must meet the fol­low­ing re­quire­ments:

a.
the long-term ex­ist­ence and qual­ity of the data are guar­an­teed.
b.
the data are se­cured in ac­cord­ance with re­cog­nised stand­ards and the cur­rent state of the art;
c.
the pro­gram­ming and the file format for the data are doc­u­mented.

16 In­ser­ted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

Art. 15b Structure of the donor data register 17  

1 The re­gister con­tains a dir­ect­ory of the sperm donors.

2 Each sperm donor file con­tains the fol­low­ing in­form­a­tion:

a.
the data trans­mit­ted by the at­tend­ing doc­tor with the re­gis­tra­tion form for the sperm donor data (Art. 16 para. 1);
b.
the res­ults of the med­ic­al ex­am­in­a­tions (Art. 16 para. 1);
c.
oth­er donor data stored at the re­quest of the sperm donor (Art. 17).

17 In­ser­ted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

Art. 16 Transmission of the data to the Federal Office 18  

1 The data are trans­mit­ted by the at­tend­ing doc­tor to the Fed­er­al Of­fice in ac­cord­ance with Art­icles 24 and 25 of the Act at the same time as the re­port of the sperm donor data; the form may be trans­mit­ted on pa­per (Art. 16a) or elec­tron­ic­ally (Art. 16b); the Fed­er­al Of­fice is­sues the form.

2 The oth­er data may be trans­mit­ted at a time later than that spe­cified in para­graph 1.

3 The re­gis­tra­tion form for sperm donor data con­tains the fol­low­ing data:

a.
re­lat­ing to the donor:
1.
name and first name, date of birth and place of birth, place of res­id­ence, place of ori­gin or na­tion­al­ity, oc­cu­pa­tion and edu­ca­tion,
2.
date of the sperm dona­tion,
3.
res­ults of the med­ic­al ex­am­in­a­tions,
4.
de­scrip­tion of the phys­ic­al ap­pear­ance: stature, size, hair col­our, eye col­our, skin col­our, spe­cial fea­tures;
b.
re­lat­ing to the re­cip­i­ent of the sperm dona­tion and her hus­band or her wife:19
1.
name and first name, date of birth and place of birth, place of res­id­ence, place of ori­gin or na­tion­al­ity,
2.
date of the in­sem­in­a­tion or the em­bryo trans­fer;
c.
re­lat­ing to the child, if known by the at­tend­ing doc­tor: name and first name, date of birth and place of birth, sex, place of res­id­ence; if de­tails of the birth are not known: the prob­able date of birth;
d.
re­lat­ing to the doc­tor who stored or ar­ranged the sperm dona­tion, where this doc­tor is not the at­tend­ing doc­tor: name and ad­dress.

18 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2012 (AS 20126097).

19 Amended by No II of the O of 30 March 2022, in force since 1 Ju­ly 2022 (AS 2022 243).

Art. 16a Transmission in paper form 20  

1 If the form is com­pleted by hand, it must be com­pleted legibly in block cap­it­als and signed.

2 If the form is il­legible, in­com­plete, not signed or de­fect­ive in some oth­er way, the Fed­er­al Of­fice may re­turn it to the doc­tor, giv­ing no­tice that he or she will be in breach of the ob­lig­a­tion un­der Art­icle 25 of the Act to trans­mit the data if the noted de­fects are not rec­ti­fied.

3Data may be trans­mit­ted in ac­cord­ance with Art­icle 24 of the Act and Art­icle 17 of this Or­din­ance by re­gistered post or by private cour­i­er.

20 In­ser­ted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2012 (AS 20126097).

Art. 16b Transmission in electronic form 21  

1 The Fed­er­al Of­fice may re­quest doc­tors who wish to trans­mit the data elec­tron­ic­ally that they re­gister with a re­cog­nised plat­form for the se­cure ser­vice in ac­cord­ance with Art­icle 2 the Or­din­ance of 18 June 201022 on Elec­tron­ic Ser­vice in Civil and Crim­in­al Pro­ceed­ings and Debt En­force­ment and Bank­ruptcy Pro­ced­ures.

2 The doc­tors shall use the elec­tron­ic form provided by the Fed­er­al Of­fice on its web­site, on the se­cure ser­vice plat­form or by post.

3 The form must bear a qual­i­fied elec­tron­ic sig­na­ture in ac­cord­ance with Art­icle 2 of the Fed­er­al Act of 18 March 201623 on Elec­tron­ic Sig­na­tures.24

4 A cer­ti­fied elec­tron­ic sig­na­ture is not re­quired if iden­ti­fic­a­tion of the sender and the in­teg­rity of the trans­mis­sion is guar­an­teed in some oth­er suit­able way.

5 The res­ult of the med­ic­al ex­am­in­a­tions is trans­mit­ted to the Fed­er­al Of­fice in PDF/A format.

6 The doc­tors shall send doc­u­ments that are not elec­tron­ic­ally trans­mit­ted by re­gistered post or by private cour­i­er to the Fed­er­al Of­fice.

7 The elec­tron­ic files shall be trans­mit­ted to the elec­tron­ic postal ad­dress of the Fed­er­al Of­fice and en­cryp­ted us­ing its pub­lic key.

8 Re­gis­tra­tion with the se­cure ser­vice plat­form is deemed to be con­sent to the Fed­er­al Of­fice serving doc­u­ments elec­tron­ic­ally. Con­sent may be re­voked at any time.

9 The prin­ciples re­lat­ing to the de­tec­tion and rec­ti­fic­a­tion of de­fects in forms trans­mit­ted on pa­per (Art. 16a para. 2) ap­ply mu­tatis mutandis.

21 In­ser­ted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

22 SR 272.1

23 SR 943.03

24 Amended by An­nex No II 8 of the O of 23 Nov. 2016 on Elec­tron­ic Sig­na­tures, in force since 1 Jan. 2017 (AS 2016 4667).

Art. 17 Storage of additional donor data  

At the re­quest of the sperm donor, ad­di­tion­al donor data, in par­tic­u­lar pho­to­graphs of the donor, shall be stored as well as the data spe­cified in Art­icle 24 of the Act.

Art. 18 Updating of stored data 25  

At the re­quest of the treated couple, the data held in the donor data re­gister shall be up­dated. The couple shall provide the in­form­a­tion re­quired for this pur­pose.

25 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

Art. 19 Security of stored data 26  

1 The Fed­er­al Of­fice shall en­sure that the data in the donor data re­gister and the data in ac­cord­ance with Art­icle 15b para­graph 2 are se­curely stored in ac­cord­ance with the prin­ciples of data pro­tec­tion le­gis­la­tion.

2 In par­tic­u­lar, it shall en­sure pro­tec­tion against fire, wa­ter, theft and un­au­thor­ised pro­cessing of the data.

26 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

Art. 19a Electronic data carriers 27  

1 The files trans­mit­ted in pa­per form shall be di­git­al­ised and stored in elec­tron­ic form. Fol­low­ing di­git­al­isa­tion, the pa­per cop­ies shall be des­troyed.

2 The Fed­er­al Of­fice may del­eg­ate these du­ties to an ex­tern­al agency, which un­der­takes in terms of a writ­ten agree­ment to re­cord all the data elec­tron­ic­ally, treat it as con­fid­en­tial and guar­an­tee its se­cur­ity. Art­icle 10a of the Fed­er­al Act of 19 June 199228 on Data Pro­tec­tion ap­plies mu­tatis mutandis.

3 The Fed­er­al Of­fice shall con­firm on re­quest that the di­git­al­ised doc­u­ments cor­res­pond to their ori­gin­als in pa­per form

27 In­ser­ted by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2013 (AS 20126097).

28 SR 235.1

Art. 20 Archiving and destruction of the data 29  

1 On ex­piry of the re­ten­tion peri­od of 80 years (Art. 26 of the Act), the data in the donor data re­gister and the data un­der Art­icle 15b para­graph 2 shall be offered to the Fed­er­al Archives for archiv­ing.

2 The data re­garded by the Fed­er­al Archives as not worthy of archiv­ing shall be des­troyed.

29 Amended by No I of the O of 31 Oct. 2012, in force since 1 Jan. 2012 (AS 20126097).

Section 2 Procedure for Disclosure of Information

Art. 21 Request for information  

1 The child must sub­mit to the Fed­er­al Of­fice a writ­ten re­quest for in­form­a­tion in ac­cord­ance with Art­icle 27 para­graph 1 or 2, spe­cify­ing the moth­er’s per­son­al data.

2 The child must provide evid­ence of his or her iden­tity in the form of a copy of a pass­port, iden­tity card or an equi­val­ent iden­tity doc­u­ment and demon­strate that the re­quire­ments spe­cified in Art­icle 27 para­graph 1 or 2 of the Act are met.30

3 If the child is evid­ently in­cap­able of act­ing on his or her own be­half, the Fed­er­al Of­fice may re­quest him or her to en­list a rep­res­ent­at­ive.31

30 Amended by No I of the O of 14 Nov. 2018, in force since 1 Jan. 2019 (AS 2018 4681).

31 Amended by No I of the O of 14 Nov. 2018, in force since 1 Jan. 2019 (AS 2018 4681).

Art. 22 Notification of the sperm donor  

1 If the child ful­fils the re­quire­ments spe­cified in Art­icle 27 para­graph 1 or 2 of the Act and re­quests in­form­a­tion on the per­son­al data of the sperm donor, the Fed­er­al Of­fice shall as­cer­tain the lat­ter’s cur­rent ad­dress. In do­ing so, the Fed­er­al Of­fice shall as far as pos­sible avoid in­dic­at­ing the pur­pose of the in­quiry.

2 Fed­er­al, can­ton­al and com­mun­al au­thor­it­ies that can provide the rel­ev­ant in­form­a­tion are ob­liged to as­sist the Fed­er­al Of­fice at its re­quest.

3 The Fed­er­al Of­fice shall in­form the sperm donor of the fact that his per­son­al data are to be dis­closed to the child. It shall grant him an ap­pro­pri­ate peri­od to ex­press his wishes con­cern­ing per­son­al con­tact with the child.

Art. 23 Provision of information to the child 32  

1 If the re­quire­ments of Art­icle 27 para­graph 1 or 2 of the Act are met, the child may choose wheth­er to be provided in­form­a­tion:

a.
by com­mu­nic­a­tion by post;
b.
by a doc­tor, a per­son trained in so­cial psy­cho­logy, or a spe­cial­ist or­gan­isa­tion of the child’s choice.

2 The per­son­al de­tails of the sperm donor shall be provided to the child in a writ­ten re­port.

3 If the re­quire­ment in Art­icle 27 para­graph 1 of the Act is not met, the Of­fice shall in­form the child in writ­ing that he or she is not yet en­titled to be provided with in­form­a­tion.

4 If the re­quire­ment in Art­icle 27 para­graph 2 of the Act is not met, the Of­fice shall in­form the child in writ­ing that he or she has no le­git­im­ate in­terest and, provided the re­quire­ment in Art­icle 27 para­graph 1 of the Act is met, that he or she may choose how in­form­a­tion is provided in ac­cord­ance with para­graph 1.

5 The Of­fice shall no­ti­fy the child if the donor could not be found or could not be re­li­ably iden­ti­fied, failed to an­swer or de­clined any per­son­al con­tact.

6 It shall ad­vise the child with re­gard to the coun­selling op­tions avail­able.

32 Amended by No I of the O of 14 Nov. 2018, in force since 1 Jan. 2019 (AS 2018 4681).

Art. 2433  

33 Re­pealed by No I of the O of 14 Nov. 2018, with ef­fect from 1 Jan. 2019 (AS 2018 4681).

Art. 25 Data protection  

1 In any con­tacts with the sperm donor or with the child, strict con­fid­en­ti­al­ity shall be ob­served by the per­sons and au­thor­it­ies con­cerned.

2 Be­fore any con­tacts with the sperm donor, his iden­tity must be se­curely es­tab­lished.

Art. 26 Charges  

The charges and ex­penses in the dis­clos­ure pro­ced­ure shall be based on the Or­din­ance of 27 Oc­to­ber 199934 on Civil Status Fees.

Chapter 3 Final provisions

Art. 27 Amendment of existing legislation  

...35

35 The amend­ments may be con­sul­ted un­der AS 2000 3068.

Art. 28 Transitional provisions to the Amendment of 21 June 2017 36  

1 Li­cence hold­ers un­der Art­icle 8 para­graph 1 let­ter a of the Act who are already us­ing re­pro­duct­ive tech­niques when the Amend­ment of 21 June 2017 comes in­to force and who wish to con­tin­ue with such activ­it­ies must sub­mit an ap­plic­a­tion to the su­per­vis­ory au­thor­ity with­in three years con­tain­ing proof that they meet the re­quire­ments un­der Art­icle 4 para­graph 1 here­of. They may con­tin­ue their activ­it­ies un­til the de­cision of the su­per­vis­ory au­thor­ity takes full ef­fect.

2 Li­cence hold­ers un­der Art­icle 8 para­graph 1 let­ter a of the Act who are already us­ing re­pro­duct­ive tech­niques with ana­lyses of ge­net­ic ma­ter­i­al from re­pro­duct­ive cells when the Amend­ment of 21 June 2017 comes in­to force and who wish to con­tin­ue with such activ­it­ies must sub­mit an ap­plic­a­tion to the su­per­vis­ory au­thor­ity with­in three years con­tain­ing proof that they meet the re­quire­ments un­der Art­icle 9 para­graph 3 of the Act and Art­icles 4 para­graph 1 and 6 para­graph 2 here­of. They may con­tin­ue their activ­it­ies un­til the de­cision of the su­per­vis­ory au­thor­ity takes full ef­fect.

36 Amended by No I of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

Art. 29 Commencement  

This Or­din­ance comes in­to force on 1 Janu­ary 2001.

Annex 1 Annex 2 3738

37 Originally: Annex. Repealed by No II of the O of 31 Oct. 2012, with effect from 1 Jan. 2013 (AS 20126097).

38 Inserted by No II of the O of 21 June 2017, in force since 1 Sept. 2017 (AS 2017 3651).

(Art. 4 para. 1 let. c)

Quality management system

European Standard ISO/IEC 17025:2005 (General Requirements for the Competence of Testing and Calibration Laboratories) or ISO 15189:2012 (Medical Laboratories – Requirements for Quality and Competence)39.

39 The standards may be inspected at the Federal Office of Public Health, Schwarzenburgstrasse 157, 3003Bern, or obtained from the Swiss Association for Standardisation, Sulzerallee 70, 8404Winterthur; www.snv.ch.

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