Key Benefits:
16 March 2007 (State on 15 October 2008)
The Swiss Federal Council,
See art. 67, para. 2, of the Law of 8 October 2004 on Transplantation 1 ,
Stops:
1 This order regulates the fees collected for the decisions rendered, the benefits provided and the controls carried out (administrative acts) by the federal authorities responsible for the enforcement of the legislation on transplantation.
2 It does not apply to administrative acts:
The provisions of the General Order of 8 September 2004 on emoluments (OGEmol) 1 Apply to the extent that this order does not provide for any specific regulation.
1 The fees collected by the federal implementing authorities for their administrative acts shall be calculated according to the schedule set out in the Annex, depending on the time invested.
2 If the annex does not set an amount for the administrative act concerned, the fees shall be calculated on the basis of the time invested.
3 The hourly rate for the calculation of investment time is determined on the basis of personnel costs and the cost of federal government workstations as reported by the Federal Finance Authority.
4 A supplement of up to 50 % of the rates of the ordinary scale may be charged for the administrative acts referred to in Art. 5, para. 3, OGEmol 1 .
The amount of fees collected for administrative acts which have not yet been completed at the time of entry into force of this order shall be determined in accordance with Art. 35 to 39 of the order of 26 June 1996 on the control of transplants 1 .
1 [RO 1996 2309, 1999 1403, 2001 1508 3294 hp. II 10, 2002 82. RO 2007 1961 s. 54]
This order shall enter into force on 1 Er July 2007.
(art. 3, para. 1)
| Francs |
||
| 1 |
Granting or renewing an authorization for: |
|
| 1.1 |
Transplant centres according to art. 16 (depending on the type and number of transplant programs) |
5,000-30,000 |
| 1.2 |
Storage of tissues or cells according to s. 17 |
500-20,000 |
| 1.3 |
The importation or exportation under s. 18 of tissues or cells, as well as organs whose allocation is not defined according to Art. 16 to 23 of the Act of 8 October 2004 on Transplantation |
500-2,000 |
| 1.4 |
The use of genetically modified organs, tissues and cells as part of a standard treatment under s. 19 |
1000-20,000 |
| 1.5 |
A clinical trial for the transplantation of genetically modified organs, tissues or cells according to s. 31 |
500-5,000 |
| 1.6 |
A clinical trial for the transplantation of tissues or cells from embryos or fetuses according to s. 34 |
500-10,000 |
| 1.7 |
Transplantation of tissues or cells derived from embryos or fetuses as part of a standard treatment under s. 34 |
1000-20,000 |
| 2 |
Suspension or withdrawal of an authorisation for: |
|
| 2.1 |
Transplant centres according to art. 16 (depending on the type and number of transplant programs) |
500-5,000 |
| 2.2 |
Storage of tissues or cells according to s. 17 |
200-1000 |
| 2.3 |
The importation or exportation under s. 18 of tissues or cells, as well as organs whose allocation is not defined according to Art. 16 to 23 of the Act of 8 October 2004 on Transplantation |
200-500 |
| 2.4 |
The use of genetically modified organs, tissues or cells as part of a standard treatment under s. 19 |
200-1000 |
| 2.5 |
A clinical trial for the transplantation of genetically modified organs, tissues or cells according to s. 31 |
200-500 |
| 2.6 |
A clinical trial for the transplantation of tissues or cells from embryos or fetuses according to s. 34 |
200-500 |
| 2.7 |
Transplantation of tissues or cells derived from embryos or fetuses as part of a standard treatment under s. 34 |
200-1000 |
| 3 |
Amendment of an authorisation for: |
|
| 3.1 |
Transplant centres according to art. 16 (depending on the type and number of transplant programs) |
200-10 000 |
| 3.2 |
Storage of tissues or cells according to s. 17 |
200-5,000 |
| 3.3 |
The importation or exportation under s. 18 of tissues or cells, as well as organs whose allocation is not defined according to Art. 16 to 23 of the Act of 8 October 2004 on Transplantation |
200-2,000 |
| 3.4 |
The use of genetically modified organs, tissues or cells as part of a standard treatment under s. 19 |
200-10 000 |
| 3.5 |
A clinical trial for the transplantation of genetically modified organs, tissues or cells according to s. 31 |
200-2,000 |
| 3.6 |
A clinical trial for the transplantation of tissues or cells from embryos or fetuses according to s. 34 |
200-5,000 |
| 3.7 |
Transplantation of tissues or cells derived from embryos or fetuses as part of a standard treatment under s. 34 |
200-10 000 |
| 4 |
Other emoluments |
|
| 4.1 |
Receipt and review of documents concerning a declaration for a clinical trial of organ, tissue or cell transplantation under s. 28 |
500-1000 |
| 4.2 |
Receipt and review of documents relating to an essential amendment to a statement already considered for a clinical trial for the transplantation of organs, tissues or cells according to s. 32 |
200-500 |
| 4.3 |
Inspections under s. 40 per half day and per inspector (without preparation or report), depending on the work involved |
800 |
| 4.4 |
Reporting |
500-1000 |
| 4.5 |
Establishment of certificates and certificates |
100-200 |
| 4.6 |
Establishing callbacks |
100-300 |
| 4.7 |
Additional Expense 3 The Federal Office of Public Health (FOPH) for the manual entry and transfer of data concerning declarations 4 And requests 5 That are not in the form prescribed by the FOPH. |
100-300 |
| Francs |
||
| 1 |
Granting or renewing an authorization for: |
|
| 1.1 |
A clinical trial of xenotransplantation under s. 3 |
500-20,000 |
| 1.2 |
Xenotransplants as part of a standard treatment under s. 13 |
1000-30,000 |
| 2 |
Suspension or withdrawal of an authorisation for: |
|
| 2.1 |
A clinical trial of xenotransplantation under s. 3 |
200-500 |
| 2.2 |
Xenotransplants as part of a standard treatment under s. 13 |
200-1000 |
| 3 |
Amendment of an authorisation for: |
|
| 3.1 |
A clinical trial of xenotransplantation under s. 3 |
200-5,000 |
| 3.2 |
Xenotransplants as part of a standard treatment under s. 13 |
200-10 000 |
| 4 |
Other emoluments |
|
| 4.1 |
Inspections under s. 30 per half day and per inspector (without preparation or report), depending on the work involved |
800 |
| 4.2 |
Reporting |
500-1000 |
| 4.3 |
Establishment of certificates and certificates |
100-200 |
| 4.4 |
Additional Expense 7 From the OFSP for manual entry and transfer of data relating to applications 8 That are not filed in the form prescribed by the FOPH. |
100-300 |
1 Update as per c. I of the O of 10 seven. 2008, effective since October 15. 2008 ( RO 2008 4473 ).
2 RS 810.211
3 Forms in electronic form are available for the implementation of the Act of 8 October. 2004 on transplantation; these forms allow persons subject to the obligation to declare and to those who file a request to submit their particulars and data themselves (www.donneestransplantation.admin.ch).
4 This is part of the returns under s. 15, 21, para. 2, 22, para. 2, and 28 of the O of 16 March 2007 on transplantation, as well as the modification of declarations already examined.
5 This includes requests for changes to already authorized activities.
6 RS 810.213
7 Forms in electronic form are available for the implementation of the Act of 8 October. 2004 on transplantation; these forms allow applicants to submit their own information and data (www.donneestransplantation.admin.ch).
8 This includes requests for changes to already authorized activities.
