### in the cases referred to in article 16 , 21 and 49a , a host member state shall decide on validation of a european professional card under paragraph 1 within one month as from the date of receipt of the european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . that request shall not suspend the period of one month . ### in the cases referred to in article 16 , 21 and 49a , a host member state shall decide on validation of a european professional card under paragraph 1 within one month as from the date of receipt of the european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . that request shall suspend the one month period .


### member states shall ensure that all requirements , procedures and formalities relating to matters covered by this directive may be easily completed , at a distance and by electronic means , through the relevant point of single contact . ### member states shall ensure that all requirements , procedures and formalities relating to matters covered by this directive may be easily completed , at a distance and by electronic means , through the relevant point of single contact , if they fall within the scope of directive 2005 / 36 / ec .


### basic dental training shall comprise a total of at least five years of full - time theoretical and practical study , which may also be expressed with the equivalent ects credits , comprising at least the programme described in annex v , point 5 . 3 . 1 and given in a university , in a higher institute providing training recognised as being of an equivalent level or under the supervision of a university . ### basic dental training shall last a total of at least five years and consist of at least 5000 hours of full - time theoretical and practical study , which may also be expressed as an additional criterion with the equivalent ects credits , comprising at least the programme described in annex v , point 5 . 3 . 1 and at a university or at a higher institute providing training recognized as being of an equivalent level , or under the supervision of a university , covering at least the study programme referred to in annex v , point 5 . 4 . 1 .


### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , the adaptations of the list of activities set out in annex iv , clarifying the knowledge and skills for architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### member states shall ensure that the points of single contact and the competent authorities respond as quickly as possible to any request for information addressed to the point of single contact . to this end , they may also refer such request for information to the assistance centers mentioned in article 57b and inform the citizen concerned . ### member states shall ensure that requests for information addressed to the points of single contact and the competent authorities are dealt with as quickly as possible . to this end , they may also refer such request for information to the assistance centers mentioned in article 57b and inform the citizen concerned .


### the knowledge , skills and competences for such common training framework shall refer to levels of the european qualifications framework , as defined in annex ii of the recommendation of the european parliament and of the council on the establishment of the european qualifications framework for lifelong learning ; ### the knowledge , skills and competences for such common training framework shall refer to the levels of article 11 of this directive ; article 11 shall not be applicable to the professions regulated under annex v point 1 .


### by derogation to paragraphs 1 and 2 of this article , the competent authority of the host member state may refuse access to and pursuit of the profession to holders of an attestation of competence where the national qualification required to exercise the profession on its territory is classified under points or of article 11 . ### by derogation to paragraphs 1 and 2 of this article , the competent authority of the host member state may refuse access to and pursuit of the profession to holders of an attestation of competence in accordance with article 11 where the national qualification required to exercise the profession on its territory is classified under points , or of article 11 .


### in the cases referred to in articles 7 and 14 , a host member state shall decide on whether to recognise the holder ' s qualifications or to subject him to compensation measures within two months from the date of receipt for validation of the european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . that request shall not suspend the period of two months . ### in the cases referred to in articles 7 and 14 , a host member state shall decide on whether to recognise the holder ' s qualifications or to subject him to compensation measures within eight weeks from the date of receipt for validation of the european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . for health professions , that request may suspend for two weeks the period of eight weeks . the home member state shall provide a reply within one week .


### in the cases referred to in articles 7 and 14 , a host member state shall decide on whether to recognise the holder ' s qualifications or to subject him to compensation measures within two months from the date of receipt for validation of the european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . that request shall not suspend the period of two months . ### in the cases referred to in articles 7 and 14 , a host member state shall decide on whether to recognise the holder ' s qualifications or to subject him to compensation measures within 12 weeks from the date of receipt of the european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . that request shall not suspend the period of 12 weeks .


### basic dental training shall comprise a total of at least five years of full - time theoretical and practical study , which may also be expressed with the equivalent ects credits , comprising at least the programme described in annex v , point 5 . 3 . 1 and given in a university , in a higher institute providing training recognised as being of an equivalent level or under the supervision of a university . ### basic dental training shall last a total of at least five years and comprise at least 5000 hours of full - time theoretical and practical study , which may also be expressed as an additional criterion with the equivalent ects credits , on the basis that one academic year corresponds to 60 training credits , comprising at least the programme described in annex v , point 5 . 3 . 1 and given in a university or in a higher institute providing training recognised as being of an equivalent level or under the supervision of a university .


### the competent authority of the home member state shall verify the application , create and validate a european professional card within two weeks from the date it receives a complete application . it shall inform the applicant and the member state in which the applicant envisages to provide services , of the validation of the european professional card . the transmission of the validation information to the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following two years . ### the competent authority of the home member state shall verify the application and the supporting documentation and shall issue the european professional card within one month from the date it receives a complete application . it shall transmit the european professional card immediately to the competent authority of the host member state concerned and shall inform the applicant accordingly . the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following years .


### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate representation and consultations during its preparatory work , including experts at both european and national level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely , transparent and appropriate transmission of relevant documents to the european parliament and to the council .


### doctor of medicine of general practice possessing evidence of a formal qualification referred to in point 5 . 1 . 4 of annex v ; ### doctor of medicine possessing evidence of a formal qualification referred to in points 5 . 1 . 1 , 5 . 1 . 3 and 5 . 1 . 4 of annex v ;


### directive 2005 / 36 / ec should promote a more automatic character of recognition of qualifications for those professions which do not currently benefit from it . this should take account of the competence of member states to decide the qualifications required for the pursuit of professions in their territory as well as the contents and the organisation of their systems of education and professional training . professional associations and organisations which are representative at national and union level should be able to propose common training principles . it should take the form of a common test as a condition for acquiring a professional qualification , or training programmes based on a common set of knowledge , skills and competences . qualifications obtained under such common training frameworks should automatically be recognised by member states . ### directive 2005 / 36 / ec should promote a more automatic character of recognition of qualifications for those professions which do not currently benefit from it . this should take account of the competence of member states to decide the qualifications required for the pursuit of professions in their territory as well as the contents and the organisation of their systems of education and professional training . before introducing such training principles , member states should examine possible alternatives , particularly those that exist in member states with vocational training . professional associations and organisations which are representative at national and union level should also be able to propose common training principles . it should take the form of a common test as a condition for acquiring a professional qualification , or training programmes based on a common set of knowledge , skills and competences . qualifications obtained under such common training frameworks should automatically be recognised by member states .


### the remunerated traineeship must be carried out in a member state , under the supervision of a person providing adequate guarantees regarding their ability to provide practical training . it must be undertaken after the completion of the study referred to in paragraph 1 . the completion of the remunerated traineeship must be attested to in a certificate accompanying the evidence of formal qualifications . ### the remunerated traineeship must be carried out in a member state , and must be undertaken under the supervision of an architect or a person or body approved for that purpose by a competent authority which has adequately checked their ability to provide practical training . the completion of the remunerated traineeship must be attested to in a certificate issued by a competent authority and accompanying the evidence of formal qualifications .


### the common training framework has been prepared following a transparent due process , including with stakeholders from member states where the profession is not regulated ; ### the common training framework has been prepared following a transparent due process , including with national social partners , professional associations representing the sectoral professions , and stakeholders from member states where the profession is regulated or not regulated ;


### the profession concerned is already regulated in at least one third of all member states ; ### the profession concerned is already regulated in at least one half of all member states ;


### the competent authority of the host member state shall grant partial access to a professional activity in its territory provided that the following conditions are fulfilled : ### the competent authority of the host member state shall grant partial access to a professional activity in its territory , after consulting with the relevant national social partners and professional associations representing the sectoral professions the applicant belongs to , provided that the following conditions are fulfilled :


### member states shall designate competent authorities for issuing european professional cards . those authorities shall ensure an impartial , objective and timely processing of applications for european professional cards . the assistance centers referred to in article 57b may also act in the capacity of a competent authority to issue a european professional card . member states shall ensure that competent authorities inform citizens , including prospective applicants , on the advantages of a european professional card where it is available . ### member states shall designate competent authorities for issuing european professional cards . those authorities shall ensure an impartial , objective and timely processing of applications for european professional cards . member states shall ensure that competent authorities inform citizens , including prospective applicants , on the advantages of a european professional card where it is available .


### full - time training as a midwife of at least two years consisting of at least 3 600 hours , contingent upon possession of evidence of formal qualifications as a nurse responsible for general care referred to in annex v , point 5 . 2 . 2 ; ### full - time training as a midwife of at least two years consisting of at least 3 600 hours , which may , as a complement , be expressed with the equivalent ects credits , contingent upon possession of evidence of formal qualifications as a nurse responsible for general care referred to in annex v , point 5 . 2 . 2 . member states may grant partial exemptions to persons who have received part of their training on courses which are of at least an equivalent level .


### full - time training of at least three years as a midwife ; ### full - time training of at least three years as a midwife , consisting of at least 5000 hours of theoretical and practical training , which may , as a complement , be expressed with the equivalent ects credits . member states may grant partial exemptions to persons who have received part of their training on courses which are of at least an equivalent level . ;


### member states shall recognise evidence of formal qualifications in nursing awarded in poland , to nurses who completed training before 1 may 2004 , which did not comply with the minimum training requirements laid down in article 31 , attested by the diploma “bachelor” which has been obtained on the basis of a special upgrading programme contained in article 11 of the act of 20 april 2004 on the amendment of the act on professions of nurse and midwife and on some other legal acts , and the regulation of the minister of health of 12 april 2010 amending the regulation of the minister of health of 11 may 2004 on the detailed conditions of delivering studies for nurses and midwives , who hold a certificate of secondary school and are graduates of medical lyceum and medical vocational schools teaching in a profession of a nurse and a midwife , with the aim of verifying that the person concerned has a level of knowledge and competence comparable to that of nurses holding the qualifications which , in the case of poland , are defined in point 5 . 2 . 2 . of annex v . ### member states shall recognise evidence of formal qualifications in nursing awarded in poland , to nurses who completed training before 1 may 2004 , which did not comply with the minimum training requirements laid down in article 31 , attested by the diploma ' bachelor ' which has been obtained on the basis of a special upgrading programme contained in article 11 of the act of 20 april 2004 on the amendment of the act on professions of nurse and midwife and on some other legal acts , and the regulation of the minister of health of 11 may 2004 on the detailed conditions of delivering studies for nurses and midwives , who hold a certificate of secondary school and are graduates of medical lyceum and medical vocational schools teaching in a profession of a nurse and a midwife , replaced by article 55 . 2 of the act of 15 july 2011 on professions of nurse and midwife , and the regulation of the minister of health of 14 june 2012 on the detailed conditions of delivering higher education courses for nurses and midwives who hold a certificate of secondary school and are graduates of a medical secondary school or a post - secondary teaching in a profession of a nurse and a midwife , with the aim of verifying that the person concerned has a level of knowledge and competence comparable to that of nurses holding the qualifications which , in the case of poland , are defined in annex v , point 5 . 2 . 2 .


### upon receipt of a complete application for a european professional card , the competent authority of the home member state shall , within two weeks , verify and confirm the authenticity and validity of the submitted supporting documents , create the european professional card , transmit it for validation to the competent authority of the host member state and inform that authority on the corresponding imi file . the applicant shall be informed by the home member state of the state of the procedure . ### upon receipt of a complete application for a european professional card , the competent authority of the home member state shall , within one month from the receipt of the complete application , verify and confirm the authenticity and validity of the submitted supporting documents , create the european professional card , transmit it for validation to the competent authority of the host member state and inform thereof the applicant


### the competent authority of the home member state shall verify the application , create and validate a european professional card within two weeks from the date it receives a complete application . it shall inform the applicant and the member state in which the applicant envisages to provide services , of the validation of the european professional card . the transmission of the validation information to the host member states concerned shall constitute the declaration provided for in article 7 . the host member state may not require a further declaration under article 7 for the following two years . ### the competent authority of the home member state shall verify the application and the supporting documentation , and shall issue the european professional card within one month from the date it receives a complete application . it shall then transmit the european professional card immediately to the competent authority of the host member state concerned and inform the applicant accordingly . the host member states concerned shall constitute the declaration provided for in article 7 . without prejudice to article 8 , the host member state may not require a further declaration under article 7 for the following year .


### doctor of medicine of general practice possessing evidence of a formal qualification referred to in point 5 . 1 . 4 of annex v ; ### doctors possessing evidence of a formal qualification referred to in points 5 . 1 . 1 , 5 . 1 . 3 and 5 . 1 . 4 of annex v ;


### member states shall ensure that the points of single contact and the competent authorities respond as quickly as possible to any request for information addressed to the point of single contact . to this end , they may also refer such request for information to the assistance centers mentioned in article 57b and inform the citizen concerned . ### member states shall ensure that requests for information addressed to the points of single contact and the competent authorities are dealt with as quickly as possible . to this end , they may also refer such request for information to the assistance centers mentioned in article 57b and inform the citizen concerned .


### for the purposes of point of the first paragraph , as from [ insert date - the day after the date set out in first subparagraph of paragraph 1 of article 3 ] and every five years thereafter , the competent authorities in member states shall submit publicly available reports to the commission and to the other member states on their continuing education and training procedures related to doctors of medicine , medical specialists , nurses responsible for general care , dental practitioners , specialised dental practitioners , veterinary surgeons , midwives and pharmacists . ### for the purposes of point of the first paragraph , as from [ insert date - the day after the date set out in first subparagraph of paragraph 1 of article 3 ] and every five years thereafter , the competent authorities in member states shall submit publicly available reports to the commission and to the other member states on their continuing professional development procedures related to doctors of medicine , medical specialists , nurses responsible for general care , dental practitioners , specialised dental practitioners , veterinary surgeons , midwives and pharmacists . member states must have systems in place to ensure that professionals can regularly update their skills and knowledge about codes of professional ethics through some type of continuous professional development .


### basic dental training shall comprise a total of at least five years of full - time theoretical and practical study , which may also be expressed with the equivalent ects credits , comprising at least the programme described in annex v , point 5 . 3 . 1 and given in a university , in a higher institute providing training recognised as being of an equivalent level or under the supervision of a university . ### basic dental training shall last a total of at least five years and consist of at least 5000 hours of full - time theoretical and practical study , which may also be expressed as an additional criterion with the equivalent ects credits , comprising at least the programme described in annex v , point 5 . 3 . 1 and at a university or at a higher institute providing training recognized as being of an equivalent level , or under the supervision of a university , covering at least the study programme referred to in annex v , point 5 . 4 . 1 .


### member states shall ensure that the following information is available online and regularly updated through the points of single contact : ### member states shall ensure that the following information is available online and regularly updated through the points of single contact , which must have specialised support staff to provide advice to citizens , including advice provided in person :


### directive 2005 / 36 / ec already provides for clear obligations for professionals to have the necessary language skills . the review of that obligation has shown a need to clarify the role of competent authorities and employers notably in the interest of patients ' safety . language controls should however be reasonable and necessary for the jobs in question and should not constitute grounds for excluding professionals from the labour market in the host member state . ### directive 2005 / 36 / ec already provides for clear obligations for professionals to have the language skills that are necessary for pursuing their profession in the host member state . the review of that obligation has shown a need to clarify the role of competent authorities and employers notably in the interest of patients ' and consumers ' safety . language controls for the jobs in question should not constitute grounds for excluding professionals from the labour market in the host member state and should therefore be reasonable and necessary . the concept of reasonable and necessary should be defined in cooperation between the competent authorities , the national social partners and the national professional associations within a given sector .


### evidence of formal qualifications as a pharmacist shall attest to training of at least five years ' duration , which may also be expressed with the equivalent ects credits , including at least : ### evidence of formal qualifications as a pharmacist shall attest to training of at least five years ' duration , which may also be expressed as an additional criterion with the equivalent ects credits , including at least :


### in order to promote the free movement of professionals , while ensuring a more efficient and transparent recognition of qualifications it is necessary to provide for a european professional card . in particular that card is necessary to facilitate temporary mobility and recognition under the automatic recognition system , as well as to promote a simplified recognition process under the general system . the card should be issued upon request from a professional and after submission of necessary documents and completion of related review and verification procedures by the competent authorities . the functioning of the card should be supported by the internal market information system established by regulation no [ … ] on administrative cooperation through the internal market information system23 . this mechanism should help enhance synergies and trust among competent authorities , while at the same time eliminating duplication of administrative work for the authorities and creating more transparency and certainty for professionals . the process for the application and issuing of the card should be clearly structured and incorporate safeguards and the corresponding rights of appeal for the applicant . the card and the related workflow within imi should ensure the integrity , authenticity and confidentiality of the data stored and avoid unlawful and unauthorised access to information contained therein . ### in order to promote the free movement of professionals , while ensuring a more efficient and transparent recognition of qualifications it is necessary , mainly for professions falling under the automatic recognition procedure , to provide for a european professional card , where these professions so request . in particular that card is necessary to facilitate temporary mobility and recognition under the automatic recognition system , as well as to promote a simplified recognition process under the general system . the card should be issued upon request from a professional and after submission of necessary documents and completion of related review and verification procedures by the competent authorities . the functioning of the card should be supported by the internal market information system established by regulation no [ … ] on administrative cooperation through the internal market information system23 . this mechanism should help enhance synergies and trust among competent authorities , while at the same time eliminating duplication of administrative work for the authorities and creating more transparency and certainty for professionals . the process for the application and issuing of the card should be clearly structured and incorporate safeguards and the corresponding rights of appeal for the applicant . the card and the related workflow within imi should ensure the integrity , authenticity and confidentiality of the data stored and avoid unlawful and unauthorised access to information contained therein .


### in order to promote the free movement of professionals , while ensuring a more efficient and transparent recognition of qualifications it is necessary to provide for a european professional card . in particular that card is necessary to facilitate temporary mobility and recognition under the automatic recognition system , as well as to promote a simplified recognition process under the general system . the card should be issued upon request from a professional and after submission of necessary documents and completion of related review and verification procedures by the competent authorities . the functioning of the card should be supported by the internal market information system established by regulation no [ … ] on administrative cooperation through the internal market information system23 . this mechanism should help enhance synergies and trust among competent authorities , while at the same time eliminating duplication of administrative work for the authorities and creating more transparency and certainty for professionals . the process for the application and issuing of the card should be clearly structured and incorporate safeguards and the corresponding rights of appeal for the applicant . the card and the related workflow within imi should ensure the integrity , authenticity and confidentiality of the data stored and avoid unlawful and unauthorised access to information contained therein . ### in order to promote the free movement of professionals , while ensuring a more efficient and transparent recognition of qualifications , it is necessary to provide for a european professional card . the european professional card should strictly be used as a tool to recognise professional qualifications in another member state , in order to use the full potential of mobility in the single market , and not as a means to regulate and restrict how a profession is qualified . in particular that card is necessary to facilitate temporary mobility and recognition under the automatic recognition system , as well as to promote a simplified recognition process under the general system . the card should be issued upon request from a professional and after submission of necessary documents and completion of related review and verification procedures by the competent authorities . the functioning of the card should be supported by the internal market information system established by regulation no [ … ] on administrative cooperation through the internal market information system23 . this mechanism should help enhance synergies and trust among competent authorities , while at the same time eliminating duplication of administrative work for the authorities and creating more transparency and certainty for professionals . the process for the application and issuing of the card should be clearly structured and incorporate safeguards and the corresponding rights of appeal for the applicant . the card and the related workflow within imi should ensure the integrity , authenticity and confidentiality of the data stored and avoid unlawful and unauthorised access to information contained therein .


### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , setting the criteria for the calculation of fees related to the european professional card , establishing the details of the documentation necessary for the european professional card , the adaptations of the list of activities set out in annex iv , the adaptations of points 5 . 1 . 1 to 5 . 1 . 4 , 5 . 2 . 2 , 5 . 3 . 2 , 5 . 3 . 3 , 5 . 4 . 2 , 5 . 5 . 2 , 5 . 6 . 2 and 5 . 7 . 1 of annex v , clarifying the knowledge and skills for medical doctors , nurses responsible for general care , dental practitioners , veterinary surgeons , midwives , pharmacists and architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to supplement or amend certain non - essential elements of directive 2005 / 36 / ec , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of updating of annex i , the adaptations of the list of activities set out in annex iv , clarifying the knowledge and skills for architects , adapting the minimum periods of training for specialist medical trainings and specialist dental training , the inclusion in point 5 . 1 . 3 of annex v of new medical specialities , the amendments to the list set out in points 5 . 2 . 1 , 5 . 3 . 1 , 5 . 4 . 1 , 5 . 5 . 1 and 5 . 6 . 1 of annex v , inclusion in point 5 . 3 . 3 of annex v of new dental specialities , specifying the conditions of application of common training frameworks , and specifying the conditions of application of common training tests . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### directive 2005 / 36 / ec only applies to professionals who want to pursue the same profession in another member state . there are cases where the activities concerned are part of a profession with a larger scope of activities in the host member state . if the differences between the fields of activity are so large that in reality a full programme of education and training is required from the professional to compensate for shortcomings and if the professional so requests , a host member state should under these particular circumstances grant partial access . however , in case of overriding reasons of general interest , such as in the case of a doctor of medicine or other health professionals , a member state should be able to refuse partial access . ### directive 2005 / 36 / ec only applies to professionals who want to pursue the same profession in another member state . there are cases where the activities concerned are part of a profession with a larger scope of activities in the host member state . if the differences between the fields of activity are so large that in reality a full programme of education and training is required from the professional to compensate for shortcomings and if the professional so requests , those host member states that authorise it may under these particular circumstances grant partial access . however , in case of overriding reasons of general interest , such as in the case of a doctor of medicine or other health professionals or in the case of professions with a particular geographical character , a member state should be able to refuse partial access .


### where the commission considers it to be in the interest of the union , it may at any time , on its own initiative or upon application of interested parties or a member state , may initiate an external procurement investigation into alleged restrictive procurement measures . ### the commission may at any time , on its own initiative or upon application of interested parties , contracting authority / entity or a member state , may initiate an external procurement investigation into alleged restrictive procurement measures .


### where it is found in an investigation pursuant to article 8 , and after following the procedure foreseen in article 9 , that restrictive procurement measures adopted or maintained by that third country leads to a lack of substantial reciprocity in market opening between the union and the third country as referred to in article 6 , the commission may adopt implementing acts to temporarily limit the access of non - covered goods and services originating in a third country . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 17 . ### where it is found in an investigation pursuant to article 8 , and after following the procedure foreseen in article 9 , that there is a lack of substantial reciprocity in market opening between the union and the third country as referred to in article 2 , the commission shall adopt implementing acts to limit the access of non - covered goods and services originating in a third country . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 17 .


### paragraph 1 shall not apply where the commission has adopted the implementing act on temporary access of the goods and services from a country engaged in substantive negotiations with the union as set out in article 9 . ### paragraph 1 shall not apply where the commission has adopted the implementing act on temporary access of the goods and services from a country engaged in negotiations with the union as set out in article 9 .


### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external procurement investigation into restrictive procurement practices allegedly maintained by a third country . in particular it shall take into account the fact that the commission has approved a number of intended exclusions concerning a third country pursuant to article 6 of this regulation . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community’s rights under international trade rules , in particular those established under the auspices of the world trade organisation . ### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external investigation into restrictive procurement and concessions practices allegedly maintained by a third country . in particular it shall take into account the fact that the commission has approved a number of intended exclusions concerning a third country pursuant to article 6 of this regulation . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community’s rights under international trade rules , in particular those established under the auspices of the world trade organisation .


### where contracting authorities / entities intend to request the exclusion from procedures for the award of contracts on the basis of paragraph 1 they shall indicate this in the contract notice they publish pursuant to article 35 of directive 2004 / 18 / ec or pursuant to article 42 of directive 2004 / 17 / ec or article 26 of the directive on the award of concession contracts . ### contracting authorities / entities , who excluded economic operators on the grounds of paragraph 1 , shall indicate that fact in the contract award notice they publish pursuant to article 35 of directive 2004 / 18 / ec , article 42 of directive 2004 / 17 / ec , or article 27 of directive on award of concession contracts .


### where , after the initiation of a consultation , it appears that the most appropriate means to end a restrictive procurement practice is the conclusion of an international agreement , negotiations shall be carried out in accordance with the provisions of articles 207 and 218 of the treaty on the functioning of the european union . if a country has engaged in substantive negotiations with the european union concerning market access in the field of public procurement , the commission may adopt an implementing act providing that goods and services from that country cannot be excluded from procedures for the award of contracts pursuant to article 6 . ### where , after the initiation of a consultation , it appears that the most appropriate means to end a restrictive procurement practice is the conclusion of an international agreement , negotiations shall be carried out in accordance with the provisions of articles 207 and 218 of the treaty on the functioning of the european union . if a country has engaged in negotiations with the european union concerning market access in the field of public procurement , the commission may adopt an implementing act providing that goods and services from that country cannot be excluded from procedures for the award of contracts pursuant to article 6 .


### the assessment by the commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and member states and / or facts collected by the commission during its investigation , and shall be concluded within a period of nine months after the initiation of the investigation . in duly justified cases this period may be extended by three months . ### the assessment by the commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and member states and / or facts collected by the commission during its investigation , and shall be concluded within a period of three months after the initiation of the investigation . in duly justified cases this period may be extended by three months .


### in the event that a consultation with a third country does not lead to satisfactory results within 15 months from the day the consultation with the third country started , the commission shall terminate the consultation and consider acting under article 10 to adopt implementing acts to limit the access of goods and services originating in a third country . ### in the event that a consultation with a third country does not lead to satisfactory results within 12 months from the calendar day the consultation with the third country started , the commission shall terminate the consultation and consider acting under article 10 to adopt implementing acts to limit the access of goods and services originating in a third country .


### many third countries are reluctant to open their public procurement markets to international competition , or to open those markets further than what they have already done . as a result , union economic operators face restrictive procurement practices in many of the trading partner of the union . those restrictive procurement practices result in the loss of substantial trading opportunities . ### many third countries are reluctant to open their public procurement and their concessions markets to international competition , or to open those markets further than what they have already done . as a result , union economic operators face restrictive procurement practices in many of the trading partner of the union . those restrictive procurement practices result in the loss of substantial trading opportunities .


### when awarding contracts for the execution of works and / or a work , the supply of goods or the provision of services , contracting authorities / entities shall treat covered goods and services equally to goods and services originating in the european union . ### without prejudice to articles 10 and 11 , when awarding contracts for the supply of covered goods or the provision of covered services , contracting authorities / entities shall treat economic operators from third countries equally to economic operators originating in the eu to the extend , in which offered by them services and goods are covered according to annex i .


### within the context of the world trade organisation and through its bilateral relations the union advocates an ambitious opening of international public procurement markets of the union and its trading partners , in a spirit of reciprocity and mutual benefit . ### within the context of the world trade organisation and through its bilateral relations the union advocates an ambitious opening of international public procurement and concessions markets of the union and its trading partners , in a spirit of reciprocity and mutual benefit .


### for contracts with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures result in serious and recurring discriminations of eu economic operators , goods and services . ### for contracts and concessions with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement and concessions between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures in the field of procurement or the award of leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures in the field of procurement or the award of result in serious and recurring discriminations of eu economic operators , goods and services .


### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external procurement investigation into restrictive procurement practices allegedly maintained by a third country . in particular it shall take into account the fact that the commission has approved a number of intended exclusions concerning a third country pursuant to article 6 of this regulation . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community ' s rights under international trade rules , in particular those established under the auspices of the world trade organization . ### the commission should be able , on its own initiative or at the application of interested parties or a member state , to initiate at any time an external procurement investigation into restrictive procurement practices allegedly maintained by a third country . such investigative procedures should be without prejudice to council regulation no 3286 / 94 of 22 december 1994 laying down community procedures in the field of the common commercial policy in order to ensure the exercise of the community ' s rights under international trade rules , in particular those established under the auspices of the world trade organization .


### where the remedial / corrective measures taken by the third country concerned are rescinded , suspended or improperly implemented , the commission may : ### where the remedial / corrective measures taken by the third country concerned are rescinded , suspended or improperly implemented , the commission acts under article 10 to adopt implementing acts to limit the access of goods and services originating in a third country .


### within the context of the world trade organisation and through its bilateral relations the union advocates an ambitious opening of international public procurement markets of the union and its trading partners , in a spirit of reciprocity and mutual benefit . ### within the world trade organisation and within the framework of its bilateral relations , the union supports an ambitious international opening of the public procurement and concession markets of the union and of its trade partners , in a spirit of reciprocity and mutual benefit .


### this regulation lays down rules on the access of third - country goods and services to the award of contracts for the execution of works or a work , the supply of goods and the provision of services by union contracting authorities / entities , and establishes procedures supporting negotiations on access of union goods and services to the public procurement markets of third countries . ### this regulation lays down rules on the access of third - country goods and services to the award of contracts for the execution of works or a work , the supply of goods and the provision of services by union contracting authorities / entities , and establishes procedures supporting negotiations on access of union goods and services to the public procurement markets of third countries . member states or their contracting authorities / entities may restrict the access of third country goods and services to their tendering procedures only by measures provided for in this regulation .


### where an agreement referred to in point does not exist and the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . ### where an agreement referred to in point does not exist and the third country maintains restrictive procurement or concession award measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . ; adoption of the regulation will entail technical changes throughout the text . )


### ' supplier ' means any natural or legal person which offers on the market goods ; ### ' economic operator ' means any natural or legal person or public entity or group of such persons and / or entities which offers the execution of works or a work , the supply of products or the provision of services on the market ;


### by 1 january 2017 and at least every three years after the entry into force of this regulation , the commission shall submit a report to the european parliament and the council on the application of this regulation and on progress made in international negotiations regarding access for eu economic operators to public contract award procedures in third countries undertaken under this regulation . to this effect , member states shall upon request provide the commission with appropriate information . ### at least every three years after the entry into force of this regulation , the commission shall submit a report to the european parliament and the council on the application of this regulation and on progress made in international negotiations regarding access for eu economic operators to public contract award procedures in third countries undertaken under this regulation . to this effect , member states shall upon request provide the commission with appropriate information . when the commission submits its second report , it shall also submit to the european parliament and the council a legislative proposal for an amended regulation or else set out the reasons why in its view no changes are needed . should the commission not comply with this obligation , the regulation will cease to apply at the end of the second year following the submission of the second report .


### goods or services originating in least - developed countries listed in annex i to regulation no 732 / 2008 shall be treated as covered goods and services . ### goods or services originating in least - developed countries listed in annex iv to regulation no 978 / 2012 or in developing countries considered to be vulnerable due to a lack of diversification and insufficient integration within the international trading system as defined in annex vii to regulation no 978 / 2012 shall be treated as covered goods and services .


### in accordance with the principle of proportionality , it is necessary and appropriate for achievement of the basic objective of establishing a common external policy in the field of public procurement to lay down rules on the treatment of goods and services not covered by the international commitments of the european union . this regulation on the access of third - country economic operators , goods and services does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with the third paragraph of article 5 of the treaty on european union , ### in accordance with the principle of proportionality , it is necessary and appropriate for achievement of the basic objective of establishing a common external policy in the field of public procurement and concessions to lay down rules on the treatment of goods and services not covered by the international commitments of the european union . this regulation on the access of third - country economic operators , goods and services does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with the third paragraph of article 5 of the treaty on european union ,


### the assessment by the commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and member states and / or facts collected by the commission during its investigation , and shall be concluded within a period of nine months after the initiation of the investigation . in duly justified cases this period may be extended by three months . ### the assessment by the commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and member states and / or facts collected by the commission during its investigation or its regular reports on existing trade barriers in third countries , and shall be concluded within a period of three months after the initiation of the investigation . in duly justified cases this period may be extended by one month .


### ‘ covered goods or services’ means a good or service originating in a country with which the union has concluded an international agreement in the field of public procurement including market access commitments and in respect of which the relevant agreement applies . annex i to this regulation contains a list of relevant agreements ; ### ‘ covered goods or services’ means a good or service originating in a country with which the union has concluded an international agreement in the field of public procurement and concessions including market access commitments and in respect of which the relevant agreement applies . annex i to this regulation contains a list of relevant agreements ; ; adoption of the regulation will entail technical changes throughout the text . )


### where the commission has , on the basis of information available to it , reason to believe that a third country has adopted or maintains a restrictive procurement practice , it should be able to start an investigation . if the existence of a restrictive procurement practice in a third country is confirmed the commission should invite the country concerned to enter into consultations with a view to improving the tendering opportunities for economic operators , goods and services in public procurement in that country . ### where the commission has , on the basis of information available to it , reason to believe that a third country has adopted or maintains a restrictive procurement and concession practice , it should be able to start an investigation . if the existence of a restrictive procurement practice in a third country is confirmed the commission should invite the country concerned to enter into consultations with a view to improving the tendering opportunities for economic operators , goods and services in public procurement in that country .


### articles 58 and 59 of directive 2004 / 17 / ec shall be repealed with effect from the entry into force of this regulation . ### the commission shall assess whether articles 58 and 59 of directive 2004 / 17 / ec shall be maintained . in view of the conclusions of this assessment , the commission shall submit a legislative proposal repealing those articles with effect from the entry into force of this regulation .


### within the context of the world trade organisation and through its bilateral relations the union advocates an ambitious opening of international public procurement markets of the union and its trading partners , in a spirit of reciprocity and mutual benefit . ### amendmento within the world trade organisation and within the framework of its bilateral relations , the union supports an ambitious international opening of the public procurement markets of the union and of its trade partners , in a spirit of reciprocity , transparency , equal treatment and mutual benefit .


### article 21 of the treaty on european union provides that the union is to define and pursue common policies and actions , and work for a high degree of cooperation in all fields in international relations in order , inter alia , to encourage the integration of all countries into the world economy , including through the progressive abolition of restrictions on international trade . ### article 21 of the treaty on european union provides that the union is to define and pursue common policies and actions , and work for a high degree of cooperation in all fields in international relations in order , inter alia , to safeguard its values , fundamental interests , security , independence and integrity and to encourage the integration of all countries into the world economy , including through the progressive abolition of restrictions on international trade .


### where the contracting authority / entity intends , under article 69 of the directive on public procurement or under article 79 of the directive on procurement by entities operating in the water , energy , transport and postal services sectors , after verifying the explanations of the tenderer , to accept an abnormally low tender comprising goods and / or services originating outside the union , in which the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , it shall inform the other tenderers of this in writing , including the reasons for the abnormally low character of the price or costs charged . ### where the contracting authority / entity intends , under article 69 of the directive on public procurement or under article 79 of the directive on procurement by entities operating in the water , energy , transport and postal services sectors , after verifying the explanations of the tenderer , to accept an abnormally low tender comprising goods and / or services originating outside the union , in which the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , it shall inform the other tenderers of this in writing , including the reasons for the abnormally low character of the price or costs charged given by the concerned tenderer . after being informed by the contracting authority / entity of their intention to accept an abnormally low tender , the other tenderers shall have the possibility to provide relevant information to the contracting authority / entity within a reasonable period of time in order to allow the contracting authority / entity to take a decision on the acceptance in full knowledge of potential factors which might have an influence on the assessment of the abnormally low character of the price or costs charged .


### many third countries are reluctant to open their public procurement markets to international competition , or to open those markets further than what they have already done . as a result , union economic operators face restrictive procurement practices in many of the trading partner of the union . those restrictive procurement practices result in the loss of substantial trading opportunities . ### many third countries are reluctant to open their public procurement and concession markets to international competition , or to open those markets further than what they have already done . as a result , union economic operators face restrictive procurement and concessions practices in many of the trading partners of the union . those restrictive practices result in the loss of substantial trading opportunities .


### where the commission considers it to be in the interest of the union , it may at any time , on its own initiative or upon application of interested parties or a member state , may initiate an external procurement investigation into alleged restrictive procurement measures . ### the commission may at any time , on its own initiative or upon application of interested parties , contracting authority / entity or a member state , may initiate an external procurement investigation into alleged restrictive procurement measures .


### for contracts with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures result in serious and recurring discriminations of eu economic operators , goods and services . ### for contracts and concessions with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement or concessions between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive measures in the field of procurement or the award of concessions leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive measures in the field of procurement or the award of concessions result in serious and recurring discriminations of eu economic operators , goods and services .


### the objectives of improving the access of eu economic operators to the public procurement markets of certain third countries protected by restrictive procurement measures and preserving equal conditions of competition within the european single market require that the treatment of third - country goods and services not covered by the international commitments of the union be harmonised throughout the european union . ### the objectives of improving the access of eu economic operators to the public procurement and concessions markets of certain third countries protected by restrictive procurement measures and preserving equal conditions of competition within the european single market require that the treatment of third - country goods and services not covered by the international commitments of the union be harmonised throughout the european union .


### this regulation shall apply to the award of contracts where the goods or services are procured for governmental purposes and not with a view to commercial resale or with a view to use in the production of goods or in the provision of services for commercial sale . ### this regulation shall apply to the award of contracts where the goods or services are procured for governmental purposes and to the award of concessions for services provided for governmental purposes and not with a view to commercial resale or with a view to use in the production of goods or in the provision of services for commercial sale .


### for contracts with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures result in serious and recurring discriminations of eu economic operators , goods and services . ### for contracts and concessions with an estimated value equal or above eur 5 . 000 . 000 the commission should approve the intended exclusion if the international agreement concerning market access in the field of public procurement and concessions between the union and the country where the goods and / or services originate contains , for the goods and / or services for which the exclusion is proposed , explicit market access reservations taken by the union . where such an agreement does not exist , the commission should approve the exclusion where the third country maintains restrictive procurement measures in the field of procurement or the award of leading to a lack of substantial reciprocity in market opening between the union and the third country concerned . a lack of substantial reciprocity should be presumed where restrictive procurement measures in the field of procurement or the award of result in serious and recurring discriminations of eu economic operators , goods and services .


### where contracting authorities / entities intend to request the exclusion from procedures for the award of contracts on the basis of paragraph 1 they shall indicate this in the contract notice they publish pursuant to article 35 of directive 2004 / 18 / ec or pursuant to article 42 of directive 2004 / 17 / ec or article 26 of the directive on the award of concession contracts . ### contracting authorities / entities , who excluded economic operators on the grounds of paragraph 1 , shall indicate that fact in the contract award notice they publish pursuant to article 35 of directive 2004 / 18 / ec , article 42 of directive 2004 / 17 / ec , or article 27 of directive on award of concession contracts .


### ' supplier ' means any natural or legal person which offers on the market goods ; ### ' economic operator ' means any natural or legal person or public entity or group of such persons and / or entities which offers the execution of works or a work , the supply of products or the provision of services on the market ;


### for the sake of transparency , contracting authorities / entities intending to make use of their power in accordance with this regulation to exclude tenders comprising goods and / or services originating outside the european union , in which the value of the non - covered goods or services exceeds 50 % of the total value of these goods or services from procedures for the award of contracts should inform economic operators thereof in the contract notice published in the official journal of the european union . ### for the sake of transparency , contracting authorities / entities intending to make use of their power in accordance with this regulation to exclude tenders comprising goods and / or services originating outside the european union , in which the value of the non - covered goods or services exceeds 50 % of the total value of these goods or services from procedures for the award of contracts or concessions should inform economic operators thereof in the contract notice published in the official journal of the european union .


### where the commission considers it to be in the interest of the union , it may at any time , on its own initiative or upon application of interested parties or a member state , may initiate an external procurement investigation into alleged restrictive procurement measures . ### the commission shall , upon application of interested parties , a contracting authority / entity or member state , initiate an external investigation into an alleged lack of substantial reciprocity as regards procurement . should the commission decline to initiate an investigation , it shall justify its decision to the member state , interested party or the contracting entity that submitted the application .


### in accordance with article 207 tfeu the common commercial policy in the field of public procurement is to be based on uniform principles . ### in accordance with article 207 tfeu the common commercial policy in the field of public procurement and concessions is to be based on uniform principles .


### when assessing whether a lack of substantial reciprocity exists , the commission should examine to what degree public procurement laws of the country concerned ensure transparency in line with international standards in the field of public procurement and preclude any discrimination against union goods , services and economic operators . in addition , it should examine to what degree public authorities and / or individual procuring entities maintain or adopt discriminatory practices against union goods , services and economic operators . ### when assessing whether a lack of substantial reciprocity exists , the commission should examine to what degree the laws on public procurement and concessions of the country concerned ensure transparency in line with international standards in the field of public procurement and concessions and preclude any discrimination against union goods , services and economic operators . in addition , it should examine to what degree public authorities and / or individual procuring entities maintain or adopt discriminatory practices against union goods , services and economic operators .


### in order to reflect in the legal order of the european union the international market access commitments undertaken in the field of public procurement after the adoption of this regulation , the commission should be empowered to adopt acts in accordance with article 290 of the treaty on the functioning of the european union amendments to the list of international agreements annexed to this regulation . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . ### in order to reflect in the legal order of the european union the international market access commitments undertaken in the field of public procurement and concessions after the adoption of this regulation , the commission should be empowered to adopt acts in accordance with article 290 of the treaty on the functioning of the european union amendments to the list of international agreements annexed to this regulation . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### in the event that a consultation with a third country does not lead to satisfactory results within 15 months from the day the consultation with the third country started , the commission shall terminate the consultation and consider acting under article 10 to adopt implementing acts to limit the access of goods and services originating in a third country . ### in the event that a consultation with a third country does not lead to satisfactory results within 12 months from the calendar day the consultation with the third country started , the commission shall terminate the consultation and consider acting under article 10 to adopt implementing acts to limit the access of goods and services originating in a third country .


### where , after the initiation of a consultation , it appears that the most appropriate means to end a restrictive procurement practice is the conclusion of an international agreement , negotiations shall be carried out in accordance with the provisions of articles 207 and 218 of the treaty on the functioning of the european union . if a country has engaged in substantive negotiations with the european union concerning market access in the field of public procurement , the commission may adopt an implementing act providing that goods and services from that country cannot be excluded from procedures for the award of contracts pursuant to article 6 . ### where , after the initiation of a consultation , it appears that the most appropriate means to end a restrictive procurement practice is the conclusion of an international agreement , negotiations shall be carried out in accordance with the provisions of articles 207 and 218 of the treaty on the functioning of the european union . if a country has engaged in substantive negotiations with the european union concerning market access in the field of public procurement , the commission may adopt an implementing act providing that goods and services from that country cannot be excluded from procedures for the award of contracts pursuant to article 6 . the examination procedure shall apply .


### the commission should be able to prevent the possible negative impact of an intended exclusion on on - going trade negotiations with the country concerned . therefore , the commission may , where a country is engaging in substantive negotiations with the union concerning market access in the field of public procurement and the commission considers that there is a reasonable prospect of removing the restrictive procurement practices in the near future , it should be able to adopt a implementing act providing that goods and services from that country should not be excluded from procedures for the award of contracts for a period of one year . ### the commission should be able to prevent the possible negative impact of an intended exclusion on on - going trade negotiations with the country concerned . therefore , the commission may , where a country is engaging in substantive negotiations with the union concerning market access in the field of public procurement and / or concessions the commission considers that there is a reasonable prospect of removing the restrictive procurement and / or concessions practices in the near future , it should be able to adopt a implementing act providing that goods and services from that country should not be excluded from procedures for the award of contracts for a period of one year .


### upon request of contracting authorities / entities the commission shall assess whether to approve , for contracts with an estimated value equal or above eur 5 . 000 . 000 exclusive of value - added tax the exclusion from procedures for the award of contracts tenders comprising goods or services originating outside the union , if the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , under the following conditions . ### where the commission initiates an external procurement investigation as provided for in article 8 , the commission shall , upon request of contracting authorities / entities and after publication of the notice of the initiation in the official journal of the union , assess whether to approve , for contracts with an estimated value equal or above eur 5 . 000 . 000 exclusive of value - added tax the exclusion from procedures for the award of contracts tenders comprising goods or services originating outside the union , if the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , under the following conditions .


### the commission should assess whether to approve that contracting authorities / entities within the meaning of directives [ 2004 / 17 / ec , 2004 / 18 / ec and directive [ … . ] of the european parliament and the council of [ … . ] … . on the award of concession contracts ] exclude , for contracts with an estimated value equal or above eur 5 . 000 . 000 from procedures for the award of contracts goods and services not covered by the international commitments undertaken by the european union . ### the commission should assess whether to approve that contracting authorities / entities within the meaning of directives [ 2004 / 17 / ec , 2004 / 18 / ec and directive [ … . ] of the european parliament and the council of [ … . ] … . on the award of concession contracts ] exclude , for procedures for the award of contracts or concessions with an estimated value equal or above eur 5 . 000 . 000 from procedures for the award of contracts goods and services not covered by the international commitments undertaken by the european union .


### the origin of a good shall be determined in accordance with article 22 to 26 of regulation no 2913 / 1992 of the european parliament and of the council of 12 october 1992 establishing the community customs code18 . __________________ 18 oj l 302 , 19 . 10 . 1992 , p . 1 ### the origin of a good shall be determined in accordance with regulation no xxxx / yyyy of the european parliament and of the council of . . . . laying down the union customs code1 x . __________________ 1 x 2012 / 0027


### a description of the object of the contract ; ### a description of the object of the contract or concession ; ; adoption of the regulation will entail technical changes throughout the text . )


### upon request of contracting authorities / entities the commission shall assess whether to approve , for contracts with an estimated value equal or above eur 5 . 000 . 000 exclusive of value - added tax the exclusion from procedures for the award of contracts tenders comprising goods or services originating outside the union , if the value of the non - covered goods or services exceeds 50&#160 ; % of the total value of the goods or services constituting the tender , under the following conditions . ### upon request of contracting authorities / entities the commission shall assess , on the basis of the procedure provided for in article 8 , whether to approve , for contracts with an estimated value equal or above eur 5 . 000 . 000 exclusive of value - added tax the exclusion from procedures for the award of contracts tenders comprising goods or services originating outside the union , if the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , under the following conditions .


### articles 58 and 59 of directive 2004 / 17 / ec shall be repealed with effect from the entry into force of this regulation . ### following adoption of this regulation , the commission shall establish whether articles 58 and 59 of directive 2004 / 17 / ec must be repealed or amended accordingly and shall , if necessary submit a legislative proposal repealing or amending the provisions of the directive .


### the assessment by the commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and member states and / or facts collected by the commission during its investigation , and shall be concluded within a period of nine months after the initiation of the investigation . in duly justified cases this period may be extended by three months . ### the assessment by the commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and member states and / or facts collected by the commission during its investigation or its regular reports on existing trade barriers in third countries , and shall be concluded within a period of three months after the initiation of the investigation . in duly justified cases this period may be extended by one month .


### within the context of the world trade organisation and through its bilateral relations the union advocates an ambitious opening of international public procurement markets of the union and its trading partners , in a spirit of reciprocity and mutual benefit . ### amendmento within the world trade organisation and within the framework of its bilateral relations , the union supports an ambitious international opening of the public procurement markets of the union and of its trade partners , in a spirit of reciprocity , transparency , equal treatment and mutual benefit .


### a ‘ mandatory price penalty’ shall refer to an obligation for contracting entities to increase , subject to certain exceptions , the price of services and / or goods originating in certain third countries that have been offered in contract award procedures . ### .


### in the light of the overall policy of the union with regard to least - developed countries as provided for , inter alia , in council regulation no 732 / 2008 of 22 july 2008 applying a scheme of generalised tariff preferences from 1 january 2009 , it is appropriate to assimilate goods and services from these countries to union goods and services . ### in the light of the overall policy objective of the union to support the economic growth of developing countries and their integration into the global value chain , which is the basis for the establishment by the union of a generalised system of preferences as outlined in the european parliament and council regulation no 978 / 2012 , it is appropriate to assimilate goods and services from least - developed countries benefitting from the ' everything but arms ' arrangement as well as goods and services from developing countries considered to be vulnerable due to a lack of diversification and insufficient integration within the international trading system as defined respectively in annexes iv and vii to the european parliament and council regulation no 978 / 2012 applying a scheme of generalised tariff preferences , to union goods and services .


### where , after the initiation of a consultation , it appears that the most appropriate means to end a restrictive procurement practice is the conclusion of an international agreement , negotiations shall be carried out in accordance with the provisions of articles 207 and 218 of the treaty on the functioning of the european union . if a country has engaged in substantive negotiations with the european union concerning market access in the field of public procurement , the commission may adopt an implementing act providing that goods and services from that country cannot be excluded from procedures for the award of contracts pursuant to article 6 . ### where , after the initiation of a consultation , it appears that the most appropriate means to end a restrictive procurement practice is the conclusion of an international agreement , negotiations shall be carried out in accordance with the provisions of articles 207 and 218 of the treaty on the functioning of the european union .


### in the light of the overall policy of the union with regard to least - developed countries as provided for , inter alia , in council regulation no 732 / 2008 of 22 july 2008 applying a scheme of generalised tariff preferences from 1 january 2009 , it is appropriate to assimilate goods and services from these countries to union goods and services . ### in the light of the overall policy of the union with regard to least - developed countries as provided for , inter alia , in council regulation no 732 / 2008 of 22 july 2008 applying a scheme of generalised tariff preferences from 1 january 2009 , it is appropriate to assimilate goods and services from these countries to union goods and services , in order to provide the necessary economic opportunities for a better integration of their markets in the world economy .


### for contracts referred to in paragraph 1 , the commission shall adopt an implementing act concerning the approval of the intended exclusion within a period of two months commencing on the first working day following the date on which it receives the notification . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 17 . this period may be extended once by a maximum of two months in duly justified cases , in particular if the information contained in the notification or in the documents annexed thereto is incomplete or inexact or if the facts as reported undergo any substantive changes . if , at the end of this two - month period , or the extended period the commission has not adopted a decision approving or disapproving the exclusion , the exclusion shall be deemed to have been disapproved by the commission . ### for contracts referred to in paragraph 1 , the commission shall adopt an implementing act concerning the approval of the intended exclusion within a period of one month commencing on the first calendar day following the date on which it receives the notification . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 17 . this period may be extended once by a maximum of one month in duly justified cases , in particular if the information contained in the notification or in the documents annexed thereto is incomplete or inexact or if the facts as reported undergo any substantive changes . if , at the end of this one - month period , or the extended period the commission has not adopted a decision approving or disapproving the exclusion , the exclusion shall be deemed to have been disapproved by the commission .


### where the commission considers it to be in the interest of the union , it may at any time , on its own initiative or upon application of interested parties or a member state , may initiate an external procurement investigation into alleged restrictive procurement measures . ### the commission shall , upon application of interested parties , a contracting authority / entity or member state , initiate an external investigation into an alleged lack of substantial reciprocity as regards procurement . should the commission decline to initiate an investigation , it shall justify its decision to the member state , interested party or the contracting entity that submitted the application .


### in view of the fact that the access of third country goods and services to the public procurement market of the union falls within the scope of the common commercial policy , member states or their contracting authorities / entities should not be able to restrict the access of third country goods or services to their tendering procedures by any other measure than the ones provided for in this regulation . ### in view of the fact that the access of third country goods and services to the public procurement and concession market of the union falls within the scope of the common commercial policy , member states or their contracting authorities / entities should not be able to restrict the access of third country goods or services to their tendering procedures by any other measure than the ones provided for in this regulation .


### such measures may entail the mandatory exclusion of certain third - country goods and services from public procurement procedures in the european union , or may subject tenders made up of goods or services originating in that country to a mandatory price penalty . to avoid circumvention of these measures , it may also be necessary to exclude certain foreign - controlled or owned juridical persons established in the european union , that are not engaged in substantive business operations such that it has a direct and effective link with the economy of a member state concerned . appropriate measures should not be disproportionate to the restrictive procurement practices to which they respond . ### such measures may entail the mandatory exclusion of certain third - country goods and services from public procurement procedures or procedures for the award of concessions in the european union , or may subject tenders made up of goods or services originating in that country to a mandatory price penalty . to avoid circumvention of these measures , it may also be necessary to exclude certain foreign - controlled or owned juridical persons established in the european union , that are not engaged in substantive business operations such that it has a direct and effective link with the economy of a member state concerned . appropriate measures should not be disproportionate to the restrictive procurement practices to which they respond .


### ' supplier ' means any natural or legal person which offers on the market goods ; ### ' economic operator ' means any natural or legal person or public entity or group of such persons and / or entities which offers the execution of works or a work , the supply of products or the provision of services on the market ;


### goods or services originating in least - developed countries listed in annex i to regulation no 732 / 2008 shall be treated as covered goods and services . ### goods or services originating in least - developed countries listed in annex iv to regulation no 978 / 2012 or in developing countries considered to be vulnerable due to a lack of diversification and insufficient integration within the international trading system as defined in annex vii to regulation no 978 / 2012 shall be treated as covered goods and services .


### upon request of contracting authorities / entities the commission shall assess whether to approve , for contracts with an estimated value equal or above eur 5 . 000 . 000 exclusive of value - added tax the exclusion from procedures for the award of contracts tenders comprising goods or services originating outside the union , if the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , under the following conditions . ### where the commission initiates an external procurement investigation as provided for in article 8 , the commission shall , upon request of contracting authorities / entities and after publication of the notice of the initiation in the official journal of the union , assess whether to approve , for contracts with an estimated value equal or above eur 5 . 000 . 000 exclusive of value - added tax the exclusion from procedures for the award of contracts tenders comprising goods or services originating outside the union , if the value of the non - covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender , under the following conditions .