Tissues and cells - questions and answers
Is there a public register of all authorised tissue establishments and testing centres in Denmark?
Where on the website can I find the Danish Health and Medicines Authority’s ‘standards for washing of sperm cells intended for partner or donor insemination’?
Find the standards under schedule 4 “Bilag 4 – Fortegnelser og Standarder”) in the Danish Drug Standards.
Must procurement sites be authorised to perform tissue establishment activities?
No. Procurement sites are not required to be authorised for tissue establishment activities, but procurement sites must register with the Danish Health and Medicines Authority of:
- its geographical location,
- the name of the doctor responsible,
- the types of human tissues and cells being procured.
Procurement sites must register this information via the e-form (in Danish only) Meddelelse om udtagningsaktiviteter (Registration of procurement activities).
Procurement sites are governed by the Danish National Board of Health’s executive order no. 1427 on the quality and safety of donation, procurement and testing (human tissues and cells).
Danish title: ”Bekendtgørelse nr. 1427 om kvalitet og sikkerhed ved donation og udtagning og testning (humane væv og celler)”.
Tissue establishments receiving tissues and cells from procurement sites are responsible for ensuring that procurement complies with the requirements of the executive order. The Danish Health and Medicines Authority supervises the procurement sites.
What does 'distribution' and 'import' cover?
’Distribution' and ’import’ are defined in the Danish executive order no. 1458 of 15 December 2009 on authorisation, control, and reporting of severe adverse reactions and events regarding handling of human tissues and cells. (Danish title: Bekendtgørelse nr. 1458 af 15. december 2009 om tilladelse til, kontrol med samt indberetning af alvorlige bivirkninger og alvorlige uønskede hændelser ved håndtering af humane væv og celler).
Distribution is transportation and delivery of tissues and cells within Denmark and between Denmark and another country within the European Union and the European Economic Area.
Import is transportation and delivery of tissues and cells to Denmark from another country outside the European Union and the European Economic Area (third countries).
Where is the application form for authorisation of tissue establishment activities?
Go to the application form: Ansøgning om håndtering af væv og celler (in Danish only).
Must research centres that use tissues and cells apply for authorisation of tissue establishment activities?
Research centres are only required to apply if the tissues and cells used in research are for human use.
Which testing laboratories must be authorised to perform tests for the release of human tissues and cells?
Laboratories which test for markers of HIV, hepatitis B, hepatitis C, syphilis, HTLV-1, and for Gonorrhoea and Chlamydia (sperm donors) for the release of human tissues and cells must be authorised by the Danish Health and Medicines Authority to perform tests pursuant to section 4 of the Danish Tissue Act.
Is it required to apply several times if handling several types of tissues and cells?
No. In the application form (in Danish only) ansøgningsskema til ansøgning om tilladelse til vævscentervirksomhed (authorisation of tissue establishment activities), the types of tissues and cells handled must be stated.
If several types of tissues and cells are handled, the activities performed with the different types must be stated.
Is it required to apply for tissue establishment activities several times if the tissues and cells are handled at different addresses?
No, but each geographical location must be listed in Annex 1 of the application form for authorisation of tissue establishment activities (in Danish only). Danish title: ansøgningsskema til ansøgning om tilladelse til vævscentervirksomhed
Is the current authorisation still valid if a tissue establishment moves to a new address?
No. If a tissue establishment moves to a new address, the current authorisation is no longer valid. The tissue establishment must apply to the Danish Health and Medicines Authority for a new authorisation, and must not use the new premises before the authorisation has been granted.
In connection with the application, a site plan of the new premises as well as moving plans for validation protocols for the relevant equipment must be submitted to the Danish Health and Medicines Authority no later than four months before the new premises are intended to be used. Change of address will generally require inspection of the new facilities.
When must the application for renewal of authorisation of tissue establishment activities be submitted?
No later than three months before the authorisation expires.
Must a procurement site or treatment facility be authorised to store tissues and cells for 48 hours before they are distributed to a tissue establishment?
According to the Danish Health and Medicines Authority, if tissues and cells are kept longer than 48 hours, it falls under the activity “storage”. Therefore, the procurement site or treatment facility must apply for authorisation of the tissue establishment activity “storage”.
When do you apply as a gynaecology clinic, and when do you apply as a tissue establishment?
If the facility solely processes sperm cells by means of the ‘swim-up’ technique, intended for insemination by partner or donor, it can apply for authorisation through a simpler application procedure. In order to apply for this authorisation, the processing must be performed according to the Danish Health and Medicines Authority’s standards for washing of sperm cells intended for partner or donor insemination.
When and why do we have to pay an application and an annual fee?
We charge an application fee and an annual control fee for applications for authorisation of handling of human tissues and cells. The application fee is related to our technical assessment of the application and inspection in connection with the application procedure. The control fee covers costs in relation to regular inspections and additional assessment procedure.
How do we pay the annual fee to the Danish Health and Medicines Authority?
The Danish Health and Medicines Authority sends out invoices payable within 30 days.
Where can I submit additional questions about tissues and cells?
If you have any additional questions, please send them to firstname.lastname@example.org.