Friday, July 21, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
Import, export and transit section Minimize

58. To which requirements should TEs that import and export tissues comply?

 

o

the relevant national laws, regulations and standards of the importing and exporting countries

o

the WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation

o

the Declaration of Helsinki

o

all the above

 

 

59. Does the valid import of tissue in one Member State imply that this tissue will automatically also be accepted in other Member States?

 

o

yes, all EU Member States have transposed the EU Tissue and Cell Directives (EUTCD) to relevant national laws, regulations and standards

o

no, in some Member States, (some parts of) the law, regulations and standards are more stringent than the EUTCD

o

yes, the free movement of tissues within the EU lies at the heart of the EUTCD

o

no, before entering the other EU Member State, special produce import taxes will be charged

 

 

60. In the EUTCD,the terms ‘import’ and ‘export’ apply for tissue exchanges between:

 

 

o

a EU Member State and a non-EU country

o

two non-EU countries

o

EU Member States

o

all the above

 

 

61.  What are acceptable incentives for the import or export of tissues?

 

o

accessibity, quality, and timeliness of tissue supply

o

financial gain

o

lower risk of infection

o

higher quality of service

 

 

62. To which country’s requirements must tissues in transit comply?

 

o

the country from which the tissues originate

o

the country in which they are temporarily stocked (in transit) and eventually processed

o

the country to which they will eventually be transferred or exported

o

all the above

 

 

62. Who is responsible for the approval of imported tissues and the approval for exportation of tissues?

 

o

the competent authorities of the importing or exporting countries

o

the Qualified Person of the importing or exporting TE

o

the Responsible Person of the importing or exporting TE

o

all the above

 

 

63. What should the import/export register include?

 

o

details of the reason why the decision was made to import or export the tissues

o

when the tissues were imported or exported and where from or to

o

the uses to which they were put, when the tissues were transferred elsewhere

o

all the above

 

64. Why would one favour the implementation of a global coding system over a European coding system?

 

o

with the growing global circulation of transplantable material, a global coding system would allow for a better traceability

o

a global coding system would facilitate the import and export of tissues

o

the use of a global coding system could offer benefits in combating commercial trade

o

the annual import/export balance

 

 

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