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Legislation




Transport of human tissues and cells for further use on humans is very strictly regulated by the directives of the European Union. Every state can also have their own legislative regulation which has to be taken into consideration.


These rules and directives are to ensure a high standard for the transport of human tissues, cells and organs so as to avoid any violation of their safety and/or quality. Their aim is to also provide protection from any incompetent handling and trading with them. These are reasons which make the whole process uneasy to accomplish. There are a number of permits, documents and control mechanisms. Owing to these factors the process is very time-demanding and the complete preparation can take weeks.


Transportation of human tissues and cells in the European Union is regulated by Directive 2004/23/ES. So far the conditions for transport on the European level have not been specified in more detail, nevertheless, the European guideline 2013/C 68/01 on the Good Distribution Practice of Medicinal Products for Human Use is applicable within a certain range. From the point of view of transport of human tissues and cells, the most important information in the guideline is the one stating that transport must comply with high quality and safety requirements which can only be ensured by specialized units certified by a national authority of the given state.


In the Czech Republic the situation is slightly different. In the year 2012 amendments to Act no. 296/2008 Sb. and consequently to Ordinance 422/2008 Sb. directly regulating the transport regulations were adopted. In this specific case the national authority of the European Union member state adopted stricter conditions for transport than the Union. Act no. 296/2008 Sb. obliges everyone wishing to transport/ import human tissues and cells for any further use on humans to register duly. This means that every entity which would like to transport these cells must apply for a licence with the State Institute for Drug Control. The task of this institute is to check whether the given entity follows all and every necessary requirements for the transport of these specific cells.


For the safety and quality assurance of reproductive cells it is not possible, however, to let patients transport their own cells themselves.


LEGISLATION AND REPROTRANS



We know and follow the legal requirements stipulated by the European Guidelines and local authorities of the shipping and receiving institution.


Company REPROTRANS operates according to the European tissue directives (2006/17/ES, 2004/23/ES) which the Czech Republic, for instance, adopted as Act No. 296/2008 Sb. and related Ordinance no. 422/2008 Sb. As a matter of course the company undertook to follow the Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01).


Why choose us?

  • EXPERIENCE

    We are a sister company of the leading reproductive medicine clinic REPROFIT International. Being the worldwide recognized experts in the field of reproductive medicine, we understand the demands on the transport of samples, know the risks which can endanger the quality of human cells, and are able to prevent them.

  • TRANSPORT UNDER SUPERVISION

    One of the biggest risks with reproductive cells involves their exposure to X-ray radiation or unauthorized handling while opening the container. Therefore the container is never handed to any third party. Your samples are accompanied by our supervisor throughout the whole period of time, on-road and air transport. The supervisor ensures that no undesired situation occurs.

  • FLEXIBILITY

    As we know the processes on the side of medical facilities, we can provide assistance above the framework of standard services. Should the preparation come to a standstill, we are able to offer a suitable solution for both shipping and receiving institutions to speed up communication and thus, the whole preparation process.

  • SAFETY

    We are in joint contact with the Health Ministries of European countries where we carry out transport. We have of a list of local emergency contacts and emergency plans ready to be used, so we can respond without delay, to any sort of complication that may occur during the transport (including customs declartion, accidents, etc.).