EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/D4/RM 
[…](2013) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
implementing Directive 2004/23/EC as regar ds the procedures for verifying the 
equivalent standards of quality and safety of imported tissues and cells 
(Text with EEA relevance) 
 EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX  
implementing Directive 2004/23/EC as regar ds the procedures for verifying the 
equivalent standards of quality and safe ty of imported tissues and cells 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2004/23/EC of the Eu ropean Parliament and of the Council of 31 
March 2004 on setting standards of quality and safety for the donation, procurement, testing, 
processing, preservation, st orage and distribution of  human tissues and cells
1, and in particular 
Article 9(4) thereof, 
Whereas: (1) Directive 2004/23/EC lays down standards of quality and safety for the donation, 
procurement, testing, processing, preservati on, storage and distri bution of all human 
tissues and cells intended for human appl ication, and for the dona tion, procurement, 
and testing of human tissues and cells cont ained in manufactured products intended for 
human application where those products are not covered by other Union legislation, so 
as to ensure a high level of huma n health protection in the Union. 
(2) Exchanges of tissues and cells increasingl y take place on a worldwide basis and 
Directive 2004/23/EC therefore requires th at imports of tissues and cells are 
undertaken by tissue establishments accredited, designated, authorised or licensed by Member States for that purpose. An exception to that requirement is laid down in Article 9(3) of Directive 2004/23/EC allowi ng competent authorities to directly 
authorise the import of specific tissues a nd cells under the condi tions laid down in 
Article 6 of Commi ssion Directive 2006/17/EC
2. That exception is regularly used to 
allow the import of haematopoietic stem cells from bone marrow or cord blood which 
is used in the treatment of a nu mber of life-threatening conditions. 
(3) Directive 2004/23/EC, furthermore, requi res Member States and importing tissue 
establishments to ensure that imports of tissue and cells meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23/EC and calls for the establishment of procedures  to verify the equivalenc y of the quality and safety 
standards of imports of tissues and cells. T hose procedures should be  laid down in this 
Directive. 
(4) In particular, it is appropriate to esta blish authorisation and inspection schemes 
mirroring the verification proces s in place for activities related to tissues and cells 
carried out within the Union. It is also a ppropriate to lay down the procedures to be 
                                                
 
1 OJ L 102, 7.4.2004 , p. 48. 
2  Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the 
European Parliament and of the Council as regards certain technical requirements for the donation, 
procurement and testing of human tissues and cells (OJ L 38, 9.2.2006, p. 40.) EN 3   EN followed by importing tissue establishments in their relations with their third country 
suppliers. 
(5) With the exception of imports directly aut horised by competent authorities pursuant to 
Article 9(3) of Directive 2004/23/EC, all im ports of tissues and cells from third 
countries must be undertaken by importing tissue establishments . Where competent 
authorities do directly aut horise imports pursuant to Article 9(3) of Directive 
2004/23/EC, the responsibility to ensure that such imports meet quality and safety 
standards equivalent to thos e laid down in that Direct ive falls upon the competent 
authorities. 
(6) Where organisations such as centres of a pplication or manufacturers of medicinal 
products which are not accredited, designate d, authorised or licensed as tissue 
establishments under the requirements of  Directive 2004/23/EC wish to undertake 
imports of tissues and cells, they must  be accredited, designated, authorised or 
licensed as importing tissue establishments by competent authorities. Alternatively, 
such organisations may obtain tissues and cel ls originating from third countries from 
accredited, designated, authorised or license d importing tissue establishments located 
within the Union. 
(7) Where importing tissue establishments are also accredited, designated, authorised or 
licensed as tissue establishments for the act ivities they carry out within the Union, 
Member States may align their authoris ation, inspection and reporting procedures 
provided the procedures laid down in this Directive are followed.  
(8) In order to facilitate the distribution with in the Union of impor ted tissues and cells 
including where such distribution is cross-bo rder in nature, the competent authority or 
authorities should issue the certificate at testing the accredit ation, designation, 
authorisation, or licence  of the importing tissue establishment.  
(9) Inspection measures play an important role in the verification of the equivalency of 
imported tissues and cells with the quality and safety standards laid down in Directive 
2004/23/EC. Member States are therefore en couraged, where appropriate to also 
inspect third country suppliers and cooperate  with other Member States into which 
imported tissues and cells are likely to be  distributed. Member States in which the 
importing tissue establishments are located re tain the responsibil ity for deciding on the 
most appropriate measures to be undertak en and for decisions on whether on-site 
inspections of third coun try suppliers are needed. 
(10) The Operational Manual for Competent Author ities on inspections has been updated to 
take into account inspections of importing tissue establishments a nd their third country 
suppliers and is available to Member Stat es as a guidance document when undertaking 
such inspection measures. 
(11) Importing tissue establishments should verify that the standards of quality and safety 
of the tissues and cells they import into th e Union are equivalent to the standards of 
quality and safety laid down in Directive 2004/23/EC.  Written ag reements with third 
country suppliers and the documentation to  be provided and made available to 
competent authorities are key elements in en suring such verification takes place and in 
particular providing traceability  back to the donor and ensu ring that the principle of 
voluntary and unpaid donation is adhered to in line with Directive 2004/23/EC. 
Importing tissue establishments are also en couraged to audit their third country 
suppliers as part of th is verification process. EN 4   EN (12) Importing tissue establishments should ensure that the Single European Code is 
applied to imported tissues and cells in line with Commission Directive 2006/86/EC3, 
either by carrying out this task  themselves or delegating it to third country  suppliers as 
part of the terms of th eir written agreements with such suppliers.  
(13) Member States should be allowed to exem pt one-off imports from the requirements 
laid down in this Directive in respect of documentation and written agreements. Such one-off imports should, however, be carried  out by accredited, de signated, authorised 
or licensed tissue establishments and as a general rule should not take place on a regular or repeated basis from th e same third country supplier.  
(14) This Directive does not prevent Member Stat es from maintaining or introducing more 
stringent measures relating to imports of tissu es and cells, in part icular in order to 
ensure the principle of voluntary and unpaid  donation is respected, provided that the 
provisions of the Treaty are met. 
(15) The measures provided for in this Directiv e are in accordance with the opinion of the 
Tissues and Cells Regulatory Committee esta blished by Article 29(3) of Directive 
2004/23/EC, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I  
GENERAL PROVISIONS  
Article 1 
Scope 
1.    This Directive shall apply to the import into the Union of: 
(a) human tissues and cells intende d for human application; and 
(b) manufactured products deri ved from human tissues and cells intended for human 
applications, where those products are not covered by other Union legislation. 
2. Where the human tissues and cel ls to be imported are intended to be used exclusively 
in manufactured products which are cove red by other Union legislation, this 
Directive shall only apply to the donation, pr ocurement and testing which takes place 
outside of the Union as well as to ensuring traceability  from donor to recipient. 
3. This Directive shall not apply to: (a) the import of tissues and cells referred to  in Article 9(3)(a) of  Directive 2004/23/EC 
which are directly authorised by the competent authority or authorities; 
(b) the import of tissues and cells referred to  in Article 9(3)(b) of  Directive 2004/23/EC 
which are directly authorised  in case of emergencies; 
(c) blood and blood components as defined by Directive 2002/98/EC; 
(d) organs or parts of organs, as defined in Directive 2004/23/EC.    
                                                
 
3  Commission Directive 2006/86/EC of 24 october 2006 implementing Directive 2004/23/EC of the 
European Parliament and of the Council as regards certain technical requirements for the donation, 
procurement and testing of human tissues and cells (OJ L 294, 25.10.2006, p. 52.) EN 5   EN Article 2 
Definitions 
For the purposes of this Directive, the following definitions apply: 
(a) ‘emergency’ means any unforeseen situation in  which there is no practical alternative 
other than to urgently  import tissues and cells from a third country into the Union for 
immediate application to a known recipient or recipients whose health would be 
seriously endangered without such an import; 
(b) ‘importing tissue establishment’ means a tissue establishment as defined in Directive 
2004/23/EC established within the Union whic h is a party to a contractual agreement 
with a third country supplier for the import in to the Union of tissues and cells coming 
from a third country intended for human a pplication. Where a centre of application, 
end-user or manufacturer of advanced therapy medicinal products derived from 
human tissues and cells is a party to the co ntractual agreement for the import of such 
tissues and cells, it shall be considered to be the importing tissue establishment; 
(c) 'one-off import' means the import of any sp ecific type of tissue or cell which is for 
the personal use of an intende d recipient or recipients known to the importing tissue 
establishment and the third c ountry supplier before the im portation occurs. Such an 
import of any specific type of tissue or cel l shall normally not occur more than once 
for any given recipient. Imports from the same third country s upplier taking place on 
a regular or repeated basis shall not be  considered to be ‘one-off imports’; 
(d) ‘third country supplier’ means a tissue esta blishment or another body, established in 
a third country, which is responsible for the export to the Union of tissues and cells it 
supplies to an importing tissue establishment.  A third country supplier may also carry 
out one or more of the activ ities, which take place outs ide of the Union, of donation, 
procurement, testing, processing, preservation, storage or distribution of  tissues and 
cells imported into the Union; 
CHAPTER II  
OBLIGATIONS ON MEMBER STATES ' AUTHORITIES  
Article 3  
Accreditation, designation, authorisation or licensing of importing tissue establishments 
1.    Without prejudice to Ar ticle 1(3), Member States shal l ensure that all imports of 
tissues and cells from third countries are undertaken by tissue establishments accredited, designated, authorised or licensed by a competent authority or authorities 
for the purposes of these activities.  
2.    The competent authority or authorities,  having gathered the information set out in 
Annex I to this Directive and, having veri fied that the importing tissue establishment 
ensures that any imports of tissues and cel ls meet standards of quality and safety 
equivalent to the ones laid down in Dir ective 2004/23/EC, shall accredit, designate, 
authorise or license the tissue establishmen t to import tissues a nd cells and indicate 
any conditions which apply such as any restri ctions of the types of tissues and cells 
to be imported or the third country suppliers  to be used. The competent authority or 
authorities shall issue the accredited, designated, author ised or licensed importing 
tissue establishment with the certificate set out in Annex II to this Directive. EN 6   EN 3. The importing tissue establishment shall not undertake any substantial changes to its 
import activities without the prior written approval of the competent authority or 
authorities. In particular, a ny changes to the type of tissues and cells imported, the 
activities undertaken in third countries which may have an influence on the quality 
and safety of imported tissues and cells or the third country suppliers used shall be considered as substantial changes. Where an importing tissue establishment 
undertakes a one-off import of tissues or cells originating fr om a third country 
supplier not covered by its existing aut horisation, such an import shall not be 
considered as a substantial change if the importing tissue establishment is authorised to import the same type of tissues or cells from anothe r third country supplier or 
suppliers.  
4. The competent authority or authorities ma y suspend or revoke the authorisation, in 
part or in full, of an importing tissue es tablishment if inspections or other control 
measures demonstrate that such an esta blishment no longer meets the requirements 
of this Directive. 
Article 4 
Inspections and other control measures 
1.    Member States shall ensure that the competent authority or authorities organise 
inspections and other control measures of importing tissue establishments and, where 
appropriate, their third country suppliers and that importing tissue establishments 
carry out appropriate controls in order to ensure the equivalency of the quality and 
safety standards of the tissues and cells to  be imported with the standards laid down 
in Directive 2004/23/EC. The interval betw een inspections of any given importing 
tissue establishment shall not exceed two years. 
2.    Such inspections shall be carried out by officials representing the competent 
authority or authorities who shall: 
(a) be empowered to inspect importing tissue es tablishments and, where appropriate, the 
activities of any third country suppliers; 
(b) evaluate and verify the procedures and activities carried out in importing tissue 
establishments and the facili ties of third country suppliers that are relevant to 
ensuring the equivalency of the quality and sa fety standards of the tissues and cells to 
be imported with the standards la id down in Directive 2004/23/EC; 
(c) examine any documents or other records th at are relevant for this evaluation and 
verification. 
3.    Member States shall, upon a duly justif ied request from another Member State or the 
Commission, provide information on the re sults of inspections and other control 
measures relating to importing tissue esta blishments and third country suppliers. 
4.    Member States into which tissues and cells are imported shall,  upon a duly justified 
request from another Member State into  which imported tissues and cells are 
subsequently distributed, carry out insp ections or other c ontrol measures on 
importing tissue establishments  and the activities of any third country suppliers. The 
Member State in which the importing tissue establishment is located shall decide on the appropriate measures to take follo wing consultation with the Member State 
which made such a request. EN 7   EN 5. Where an on-site inspection takes place following such a request, the competent 
authority or authorities of the Member State in which the importing tissue establishment is located shall agree with th e competent authority or  authorities of the 
Member State which made such a request  on how the Member State which made 
such a request shall part icipate in the inspection. 
 
CHAPTER III  
OBLIGATIONS ON IMPORTING TISSUE ESTABLISHMENTS  
Article 5 
Applications for accreditation, designation, authorisation or licensing as an importing 
tissue establishment 
1. Tissue establishments, having taken measures  to ensure that any imports of tissues 
 and cells meet standards of quality and sa fety equivalent to the ones laid down in 
 Directive 2004/23/EC and th at imported tissues and cells  can be traced from the 
 donor to the recipient and vi ce versa, shall apply for an accreditation, designation, 
 authorisation or licence as an importing tissue establishment by: 
(a) providing to the competent authority or authorities the required information and 
documentation as set out in Annex I to this Directive; 
(b) making available and, when requested by th e competent authority or authorities, 
providing the documentation listed in  Annex III to this Directive.  
2. Member States may choose to not apply the documentation requirements of Annex 
 I, part F and Annex III to this Directive to one-off imports as defined in Article 2 of
 this Directive, provided they have suitable  national measures in place to regulate such 
 imports. Those national measures  shall ensure the following: 
(a) traceability from donor to r ecipient and vice versa; and 
(b) imported tissues and cells are not applie d to anyone other th an their intended 
recipients. 
 
Article 6  
Updated information 
1.  Importing tissue establishments shall inform  the competent authority or authorities of 
any planned substantial changes to their impor t activities or of th eir intention to cease 
their import activities co mpletely and renounce it s accreditation, designation, 
authorisation or licence issued fo r the purpose of t hose activities. 
2. Importing tissue establishments  shall notify the competent au thority or authorities of 
any serious adverse events or  reactions, reported to them by third country suppliers 
and which may influence the qua lity and safety of the tissues and cells they import. 
The information laid out in Annexes III and IV to Directive 2006/86/EC shall be included in such notifications. 
 3. The importing tissue establishment sha ll notify to the competent authority or 
authorities: EN 8   EN (a) any revocation or suspension, in part or full,  of a third country s upplier's authorisation 
to export tissues and cells; and 
(b) any other decision taken for reasons of non-compliance by the competent authority or 
authorities of the country in which the third country supplier is based and which may be relevant to the quality and sa fety of imported tissues and cells. 
Article 7 
Written agreements 
1.    Importing tissue establishments shall ha ve in place written agreements with third 
country suppliers where any of the activ ities of donation, procurement, testing, 
processing, preservation, storag e or export to the Union of tissues and cells to be 
imported into the Union are carr ied out outside of the Union.  
 Member States may choose to not apply this requirement to one-off imports as 
defined in Article 2 of this Directive, pr ovided they have suitable national measures 
in place to regulate such an imports. T hose national measures shall ensure the 
following: 
(a) traceability from donor to recipient and vice versa; and 
(b) imported tissues and cells are not app lied to anyone other than their intended 
recipients.  
2.    The written agreement between the importing tissue establishment and the third 
country supplier shall specify th e quality and safety requirem ents to be met to ensure 
the equivalency of the quality and safety standards of the tissues and cells to be 
imported with the standards laid down in  Directive 2004/23/EC. In particular, the 
written agreement shall include, as a minimu m, the contents listed in Annex IV to 
this Directive.   
3. The written agreement shall establish th e right of the competent authority or 
authorities to inspect the act ivities, including the facil ities, of any third country 
suppliers during the duration of  the written agreement and for a period of two years 
following its termination. 
4.    Importing tissue establishments shall provide copies of written agreements with third 
country suppliers to the competent authority or  authorities as part of their application 
for accreditation, designation, authorisation or licensing. 
Article 8 
Register of importing tissue establishments 
1.    Importing tissue establishments shall keep  a record of their activities, including the 
types and quantities of tissues  and cells imported, and on thei r origin and destination. 
This record shall also include the same information for any one-off imports carried 
out. The annual report referred to in Artic le 10(1) of Directive 2004/23/EC shall 
include information about those activities. 
2.    The competent authority or authorities  shall include importing tissue establishments 
in the publicly accessible register of tissue establishments laid down in Article 10(2) 
of Directive 2004/23/EC. EN 9   EN 3.    Information on the authorisations of importing tissue establishments shall also be 
made available to other Member States thr ough the network of registers referred to in 
Article 10(3) of Directive 2004/23/EC. 
 
CHAPTER IV  
FINAL PROVISIONS  
Article 9 
Transposition 
1. Member States shall adopt and publish the laws, regulations and administrative 
provisions necessary to comply with this Directive by [(18 months after entry into 
force)] at the latest. They shall forthwith communicate to the Commission the text of those provisions. 
They shall apply those provisions from [(24 months after entry into force)]. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 10 
Entry into force 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 11 
Addresses 
This Directive is addressed to the Member States. 
 
Done at Brussels,  
 For the Commission 
 The President  […] EN 10   EN ANNEX I  
Minimum requirements concerning the inform ation and documentation to be provided 
by importing tissue establishment applican ts when applying to be accredited, 
designated, authorised or licensed for the purpose of import activities  
When applying for an accreditati on, designation, authorisation or  licence for the purpose of 
import activities, the importing tissue establishm ent applicant shall, unless already provided 
as part of previous applications for accreditati on, designation, authorisation or licensing as a 
tissue establishment or importing tissue esta blishment, provide the most up-to-date 
information and, for part F, documentation on the following:  
A. General Information on the Importing Tissue Establishment (ITE)  
 
1. Name of the ITE (Company name). 2. Visiting address. 3. Postal address (if different) . 
4. Status of the applican t ITE: It should be indicated if this is the first application for 
 accreditation, designation, authorisation or li censing as an ITE or whether this is a 
 renewal application. Where the appli cant is already accredited, designated, 
 authorised or licensed as a tissue establishment, the TE compendium code  should be 
 provided. 
5. Name of applying unit (if different from the company name).  
6. Visiting address. 7. Postal address (if different). 
8. Name of the site of reception of imports (if different from the company name and 
 applying unit) . 
9. Visiting address. 10. Postal address (if different) . 
 
B. Contact Details for the Application 
 
1. Name of contact person for the application. 
2. Telephone number. 3. E-mail address. 4. Name of Responsible Person (if different from contact person) . 
5. Telephone number. 6. E-mail address. 7. URL of ITE website (if available) . 
 
C. Details of Tissues and Cells to be Imported 
 EN 11   EN 1. A list of the types of tissues and cells to be imported, including one-off imports of 
 specific types of tissues or cells. 
2. The product name  (where applicable, in accord ance with the EU  generic list)  of all 
 types of tissues and cells to be imported. 
3.  The trade name (if different to the product name)  of all types of tissues and cells to 
 be imported. 
4. The name of the third country supplier for each type of tissue and cell to be 
 imported. 
 
D. Location of Activities 
 
1. A list specifying which of the activi ties of donation, procurement, testing,  
 processing, preservation or  storage are carried out pr ior to import by the third 
 country supplier per type of tissue or cell. 
2. A list specifying which of the activities of  donation, procurement, testing,  processing, 
 preservation or storage are carried out prior to import by sub-contractors of the 
 third country supplier per type of tissue or cell. 
3. A list of all activities car ried out by the ITE subseque nt to import per type of 
 tissue or cell. 
4. The names of the third countries in which the activities prior to import take place per 
 type of tissue or cell. 
 
E. Details of Third Country Suppliers 
 
1. Name of third country supplier(s) (company name). 
2. Name of contact person. 
3. Visiting address. 
4. Postal address (if different) . 
5. Telephone number including international dialling code. 
6. Emergency contact number (if different) 
7.  E-mail address.  
F. Documentation to Accompany the Application 
 
1. A copy of the written agreement w ith the third country supplier(s). 
2. A detailed description of the flow of  imported tissues and cells from their 
 procurement to their reception at the importing tissue establishment. 
3. A copy of the third country supplier's e xport authorisation certificate or, where a 
 specific export authorisation certificate is  not issued, certification from the relevant EN 12   EN  third country competent authority or au thorities authorising the third country 
 supplier’s activities in the tissue and cells sector including exports.  
 
ANNEX II 
Certificate of Accreditation, Designation, Au thorisation or Licence to be issued by the 
competent authority or authorities to importing tissue establishments Certificate of Accreditation, Designation, Authorisation or Licence of an Importing 
Tissue Establishment EN 13   EN Importing Tissue Establishment (ITE) Details 
Name of ITE   
ITE Address and postal address (if different)  
Site of reception of imports (if different from 
the above address)   
Name of accreditation, designation, 
authorisation or licence holder  
Address of  accreditation, designation, 
authorisation or licence  holder  
Telephone number of accreditation, 
designation, authorisatio n or licence   holder  
E-mail address of  accreditation, designation, 
authorisation or licence  holder  
URL of ITE website   
Scope of Accreditation, Designation, Authorisation or Licence 
Activities in third countries  Status Type of Tissues and Cells 
Donation 
Procure
ment 
Testing 
Preservat
ion 
Processi
ng 
Storage 
Import 
EU 
Distribut
ion 
Cardiovascular, Valves         
Cardiovascular, Vessels         
Musculoskeletal, Bone         
Musculoskeletal, Cartilage          
Musculoskeletal, Tendon & Ligament          
Ocular         
Skin         
Other tissue         
Other cell         
Reproductive, Ovarian         
Reproductive, Testicular         
Reproductive, Oocytes         
Reproductive, Sperm         
Reproductive, Embryos / Zygotes         
 3CS – Third country supplier 
SC – Sub-contractor of third country 
supplier  G - Granted 
S- Suspended 
R- Revoked 
C- Cessation  
One-off imports  
Product name(s) of imported tissues and cells  
Any conditions placed on the import or 
clarifying remarks  
Third country or countries of procurement   
Third country or countries in which other 
activities take place (if different)  
Name and country of third country supplier(s)  
EU Member States in which imported tissues 
and cells will be distributed (if known)  
Competent Authority (CA) Accreditation, Designation, Authorisation or Licence EN 14   EN  
 
 
 National  accreditation, designation, 
authorisation or licence  number  
EU Compendium TE code  
Legal basis of  accreditation, designation, 
authorisation or licence   
Date of expiry of  accreditation, designation, 
authorisation or licence (if any)  
First  accreditation, de signation, authorisation 
or licence  as ITE or renewal  
Additional remarks  
Name of CA   
Name of CA Officer  
Signature of CA Officer  
Date of  accreditation, designation, 
authorisation or licence   
CA Stamp  
 EN 15   EN  
ANNEX III  
Minimum requirements concerning the docume ntation to be made available to the 
competent authority or authorit ies by tissue establishments intending to import tissues 
and cells from third countries 
 
With the exception of one-off imports as defined in Article 2 of this Directive which have 
been exempted from these documentation re quirements, the applicant importing tissue 
establishment shall make available and, unle ss already provided as part of previous 
applications for accreditation, designation, auth orisation or licensing  as an importing tissue 
establishment or tissue establishment, shal l provide when requested by the competent 
authority or authorities the most up-to-date ve rsion of the following documents regarding the 
applicant and its third country supplier(s).  
A. Documentation relating to th e importing tissue establishment 
1. A job description of the Responsible Pe rson and details of his/her relevant 
qualifications and training record; 
2. A copy of the primary label, repackage label, external package and transport 
container; 
3. A list of relevant and up-to- date versions of standard operating procedures (SOPs) 
relating to the establishment's import ac tivities including SOPs on applying the 
Single European Code, reception and storag e of imported tissues and cells at the 
importing tissue establishment, manageme nt of adverse events and reactions, 
management of recalls and traceab ility from donor to recipient. 
B. Documentation relating to the third country supplier or suppliers 
1. A detailed description of th e criteria used for donor identification and evaluation, 
information provided to the donor or donor fa mily, how consent is obtained from the 
donor or donor family and whether the donation was voluntary and unpaid or not; 
2. Detailed information on the testing centre(s)  used by third country suppliers and the 
tests performed by such centres; 
3. A detailed description of the facilities, critical equipment and materials and criteria 
used for quality control for each activity ca rried out by the third country supplier; 
4. Detailed information on the conditions for release of tissues a nd cells by the third 
country supplier or suppliers; 
5. Details of any sub-contractors used by the third country s uppliers including the 
name, location and activity undertaken; 
6. A summary of the most recent inspection of the third country supplier by the third 
country competent authority or authorities including the date of the inspection, type 
of inspection and main conclusions.  
7. A summary of the most recent audit of the third country supplier carried out by, or on 
behalf of, the importing tissue establishment; 
8. Any relevant national or international accreditation; 
 EN 16   EN ANNEX IV  
Minimum requirements concerning the cont ents of written agreements between 
importing tissue establishments and their third country suppliers 
 
With the exception of one-off imports as defined in Article 2 of this Directive which have 
been exempted from these requirements, the written agreement between the importing tissue establishment and the third country supplier sh all contain at least th e following provisions. 
1. Detailed information on the specifications of the importing tissue establishment 
aimed at ensuring that the quality and safety standards laid down in Directive 2004/23/EC are met and the mutua lly agreed roles and respon sibilities of both parties 
in ensuring that imported tissues and cells are of equivalent sta ndards of quality and 
safety; 
2. A clause ensuring that the third country s upplier provides the information set out in 
Annex III B to this Directive to the importing tissue establishment; 
3. A clause ensuring that the third count ry supplier informs the importing tissue 
establishment of any serious  adverse events or reactions which may influence the 
quality and safety of tissues and cells imported or to be im ported by the importing 
tissue establishment; 
4. A clause ensuring that the third count ry supplier informs the importing tissue 
establishment of any substant ial changes to its activities , including any revocation or 
suspension, in part or in full,  of its authorisation to e xport tissue and cells or other 
such decisions of non-compliance by the third country competent authority or 
authorities, which may influence the quality and safety of tissues and cells imported 
or to be imported by the importing tissue establishment; 
5. A clause guaranteeing the competent authorit y or authorities the right to inspect the 
activities of the third country supplier, incl uding on-site inspections, should it wish to 
do so as part of its inspection of the importing tissue establishment. The clause 
should also guarantee the impor ting tissue establishment the right to regularly audit 
its third country supplier; 
6. The agreed conditions to be met for the tr ansport of tissues a nd cells between the 
third country supplier and im porting tissue establishment; 
7. A clause ensuring that donor records relating to imported tissues and cells are kept 
by the third country supplier or its sub-cont ractor, in line with EU data protection 
rules, for 30 years following procurement and that suitable provision is made for 
their retention should the third c ountry supplier cease to operate; 
8. Provisions for the regular review and, wh ere necessary, revision of the written 
agreement including in order to reflect a ny changes in the requirements of the EU 
quality and safety standards la id out in Directive 2004/23/EC.