|Appendix 1||Fees for the approval and control of tissue establishments, cf. § 1|
Completion of charges for handling and so on of human tissues and cells
In accordance with section 20 (2), 1, in Law No 1. 273 of 1. April 2006 on the requirements for quality and safety in the handling of human tissues and cells (tissue slots) shall be determined as follows :
§ 1. For the following services from the Board of Health for the approval and control of tissue establishments, the fee shall be paid :
1) Treatment of the application for an application for tissue slots, sections 4 and 5 to handle tissues and cells at one geographic location.
2) Ongoing control activities pursuant to section 14 (4) of the VA. One and two.
Paragraph 2. The fees for the services referred to in paragraph 1. 1 is given in Appendix 1 to this notice.
Paragraph 3. The Board of Health may, in exceptional cases, be wholly or partially exempt from the payment of the fee.
Paragraph 4. By way of derogation from the date of the year a permit to perform testing, processing, preservation, storage, distribution, import or export of tissues and cells cease, full fee shall be paid for the year in question.
Paragraph 5. A tissue establishment at the beginning of the year in possession of a permit for the sections 4 and 5 of the Vacation of the VA shall pay the full annual charge for the year in question.
Paragraph 6. Permission granted in sections 2, 3 and 4, cf. Notice no. 1410 of 20. In December 2012, the authorisation, control, and the reporting of serious adverse reactions and serious adverse events in the handling of human tissues and cells in the first nine months of the year shall be paid full annual tax for the current year. Permission granted in the last three months of the year, the annual charge will be payable only the following year after year.
§ 2. The Board of Health shall notify the procedure for payment of fees.
Paragraph 2. Fees for the services referred to in section 1 (1). 1, shall be paid to the Board of Health at the latest one month after claims.
§ 3. You mentioned fees in section 1, cf. Annex 1 is regulated once a year on 1. January with the rate fixed by the Ministry of Finance for the general price and wage index. The resulting amount shall be rounded off to the nearest chronosum. The Board of Health shall publish the regulated fees in their network location.
Paragraph 2. The rate of the general price and wage index for the 2014 financial year is 0.5% that is included in the fees in section 1, cf. Annex 1.
Entry into force
§ 4. The announcement shall enter into force on 1. January 2014.
Paragraph 2. At the same time, Chapter 8 and Annex 1 shall be repealed. 1410 of 20. In December 2012, authorisation, control, and the reporting of serious adverse reactions and serious adverse incidents in the handling of human tissues and cells.
The Ministry of Health and Prevention, the 20th. December 2013
/ Nina Moss
Fees for the approval and control of tissue establishments, cf. § 1