### where a party fails to comply with the obligation to appoint a representative in accordance with paragraph 1 and has not expressed his or her consent to use an electronic user account for service in accordance with point of article 15a , any method of service permitted under the law of the forum member state may be used for service of documents during the proceedings , provided that the party concerned has been duly informed about this consequence . ; ### the first paragraph is without prejudice to requirements under union or national law imposing an obligation to appoint a representative in a member state upon parties who are domiciled in another member state for purposes other than the service of documents under this regulation .


### if the addressee has refused to accept the document in accordance with paragraphs 1 and 2 , the court or authority seised with the legal proceedings , in the course of which service was carried out , shall verify whether the refusal was well founded . ### if the addressee has refused to accept the document in accordance with paragraphs 1 and 2 , the court or authority seised with the legal proceedings , in the course of which service was carried out , shall verify whether the refusal was well founded . if the court or authority rules that the refusal was not well founded , it shall proceed with the service on the addressee of a document communicating such decision , accompanied by the original document , without undue delay and in accordance with the provisions of this regulation . the addressee may appeal against such decision , in accordance with the law of the forum member state .


### the documents are sent and received using qualified electronic registered delivery services within the meaning of regulation no 910 / 2014 of the european parliament and of the council ### the documents are sent and received using qualified electronic registered delivery services within the meaning of regulation no 910 / 2014 of the european parliament and of the council , and


### the power to adopt delegated acts referred to in article 17 shall be conferred on the commission for an indeterminate period of time from [ the date of entry into force of this regulation ] . ### the power to adopt delegated acts referred to in article 3a , in article 15a and in article 17 shall be conferred on the commission for a period of five years from [ the date of entry into force of this regulation ] .


### a delegated act adopted pursuant to article 17 shall enter into force only if no objection has been expressed either by the european parliament or by the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ; ### a delegated act adopted pursuant to article 3a , article 15a or article 17 shall enter into force only if no objection has been expressed either by the european parliament or by the council within a period of three months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council ;


### where the conditions set out in paragraph 2 are met , reasonable efforts shall be made to inform the defendant through any available channels of communication , including means of modern communication technology , for which an address or an account is known to the court seised , that court proceedings have been instituted against him or her . ### where the conditions set out in paragraph 2 are met , reasonable efforts shall be made to inform the defendant through all available channels of communication , including means of modern communication technology , for which an address or an account is known to the court seised , that court proceedings have been instituted against him or her .


### information , including in particular personal data , transmitted under this regulation shall be used by the receiving agency only for the purpose for which it was transmitted . ### in article 22 , paragraph 1 is replaced by the following : information , including in particular personal data , transmitted under this regulation shall be used by transmitting agencies , receiving agencies and central bodies only for the specific purposes set out in this regulation . personal data which are not relevant for the purposes of this regulation shall be immediately deleted .


### receiving agencies shall ensure the confidentiality of such information , in accordance with their national law . ### in article 22 , paragraph 2 is replaced by the following : 2 . transmitting agencies , receiving agencies and central bodies shall ensure the confidentiality of such information , in accordance with union and national law .


### paragraphs 1 and 2 shall not affect national laws enabling data subjects to be informed of the use made of information transmitted under this regulation . ### in article 22 , paragraph 3 is replaced by the following : 3 . paragraphs - 1 , 1 and 2 shall not affect union and national laws enabling data subjects to be informed of the use made of information transmitted under this regulation .


### this regulation shall be without prejudice to directives 95 / 46 / ec and 2002 / 58 / ec . ### in article 22 , paragraph 4 is replaced by the following : 4 . any processing of information carried out by european institutions and bodies in the framework of this regulation shall be undertaken in accordance with regulation 2001 / 45 .


### by [ two years after the date of application ] at the latest , the commission shall establish a detailed programme for monitoring the outputs , results and impacts of this regulation . ### by [ one year after the date of entry into force ] at the latest , the commission shall establish a detailed programme for monitoring the outputs , results and impacts of this regulation .


### no sooner than [ five years after the date of application of this regulation ] , the commission shall carry out an evaluation of this regulation and present a report on the main findings to the european parliament , the council and the european economic and social committee . ### no later than [ four years after the date of application of this regulation ] , the commission shall carry out an evaluation of this regulation and present a report on the main findings to the european parliament , the council and the european economic and social committee , accompanied , where appropriate , by a legislative proposal .


### a pre - condition for granting the union ' s macro - financial assistance should be that moldova respects effective democratic mechanisms – including a multi - party parliamentary system – and the rule of law , and guarantees respect for human rights . in addition , the specific objectives of the union ' s macro - financial assistance should strengthen the efficiency , transparency and accountability of the public finance management systems , the governance and supervision of the financial sector in moldova and promote structural reforms aimed at supporting sustainable and inclusive growth , employment creation and fiscal consolidation . both the fulfilment of the preconditions and the achievement of those objectives should be regularly monitored by the commission and the european external action service . ### a pre - condition for granting the union ' s macro - financial assistance should be that moldova respects effective democratic mechanisms – including a multi - party parliamentary system – and the rule of law , and guarantees respect for human rights . in addition , the specific objectives of the union ' s macro - financial assistance should strengthen the efficiency , transparency and accountability of the public finance management systems , the governance and supervision of the financial and banking sector in moldova , enhance the fight against corruption and money laundering and promote structural reforms aimed at supporting sustainable and inclusive growth , employment creation and fiscal consolidation . the union ' s macro - financial assistance should also include measures to support the implementation of the eu - moldova association agreement , including the dcfta . both the fulfilment of the preconditions and the achievement of those objectives should be regularly monitored by the commission and the european external action service . conditionality for disbursement should be fully implemented in order to strengthen incentive - based funds allocation by laying down , inter alia , clear and relevant conditions and performance indicators , as well as a more stringent application of the existing methodology to better assess the fulfilment of the preconditions and the achievement of the objectives .


### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . preventive use or use to enhance the performance of food - producing animals should in particular not be allowed . ### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit or prohibit the use of medicated feed containing antimicrobials for food - producing animals , especially in the case of certain new or antimicrobials critically important for humans . preventive use or use to enhance the performance of food - producing animals should in particular not be allowed .


### the definitions of ' food - producing animal ' , ' feed materials ' , ' compound feed ' , ' complementary feed ' , ' mineral feed ' , ' labelling ' , ' label ' , ' minimum storage life ' and ' batch ' as laid down in article 3 of regulation no 767 / 2009 ; ### the definitions of ' food - producing animal ' , ' non - food producing animals ' , ' feed materials ' , ' compound feed ' , ' complementary feed ' , ' mineral feed ' , labelling ' , ' label ' , ' minimum storage life ' and ' batch ' as laid down in article 3 of regulation no 767 / 2009 ;


### medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food - producing animals or to enhance their performance . ### medicated feed containing antibiotic veterinary medicinal products shall not be used for food - producing animals , except in prophylactic uses where there is a high risk of infection and they are allowed under the conditions of use already defined in the authorisation for the same medicinal product .


### a modernised system of social security coordination started to apply from 1 may 2010 with regulations no 883 / 2004 and no 987 / 2009 . ### a modernised system of social security coordination started to apply from 1 may 2010 with regulations no 883 / 2004 and no 987 / 2009 , with the exception of the provisions on the introduction of the electronic exchange of social security information system , intended to help the competent authorities and institutions exchange information more rapidly and more securely .


### it is necessary to guarantee legal certainty by clarifying that access to social security benefits for economically inactive mobile citizens in the host member state , may be made conditional upon that citizen holding a legal right of residence in that member state in accordance with directive 2004 / 38 / ec of the european parliament and of the council of 29 april 2004 on the right of citizens of the union and their family members to move and reside freely within the territory of the member states33 . for these purposes , an economically inactive citizen should be clearly distinguished from a jobseeker whose right of residence is conferred directly by article 45 of the treaty on the functioning of the european union . __________________ oj l 158 , 30 . 4 . 2004 , p 77 . ### it is necessary to guarantee legal certainty by clarifying that access to the special non - contributory benefits referred to in article 70 of regulation 883 / 2004 for economically inactive mobile citizens in the host member state , may be made conditional upon that citizen holding a legal right of residence in that member state in accordance with directive 2004 / 38 / ec of the european parliament and of the council of 29 april 2004 on the right of citizens of the union and their family members to move and reside freely within the territory of the member states33 . for these purposes , an economically inactive citizen should be clearly distinguished from a jobseeker whose right of residence is conferred directly by article 45 of the treaty on the functioning of the european union . __________________ oj l 158 , 30 . 4 . 2004 , p 77 .


### with a view to supporting member states in their efforts to combat fraud and error in the application of the coordination rules , it is necessary to establish a further permissive legal basis to facilitate the processing of personal data about persons to whom regulations no 883 / 2004 and no 987 / 2009 apply . this would enable a member state to periodically compare data held by its competent institutions against that held by another member state in order to identify errors or inconsistencies that require further investigation . ### with a view to supporting member states in their efforts to combat fraud and error in the application of the coordination rules , it is necessary to facilitate the processing of personal data about persons to whom regulations no 883 / 2004 and no 987 / 2009 apply , while complying fully , without exception , with the union acquis on the protection of personal data , particularly regulation 2016 / 679 of the european parliament and of the council . this would enable a member state to periodically compare data held by its competent institutions against that held by another member state in order to identify errors or inconsistencies that require further investigation .


### with a view to supporting member states in their efforts to combat fraud and error in the application of the coordination rules , it is necessary to establish a further permissive legal basis to facilitate the processing of personal data about persons to whom regulations no 883 / 2004 and no 987 / 2009 apply . this would enable a member state to periodically compare data held by its competent institutions against that held by another member state in order to identify errors or inconsistencies that require further investigation . ### with a view to supporting member states in their efforts to combat fraud and error in the application of the coordination rules , it is necessary to establish a further permissive legal basis to facilitate the processing of personal data about persons to whom regulations no 883 / 2004 and no 987 / 2009 apply , paying due respect to the relevant union data protection acquis , in particular regulation 2016 / 679 of the european parliament and of the council1a . this would enable a member state to periodically compare data held by its competent institutions against that held by another member state in order to identify errors or inconsistencies that require further investigation . ______________ 1a regulation 679 / 2016 of the european parliament and the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec .


### the relevant eu data protection acquis , in particular regulation 679 / 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec 42shall apply to the processing of personal data pursuant to this regulation . __________________ oj l 119 , 4 . 5 . 2016 , p . 1 - 88 . ### the relevant eu data protection acquis , in particular regulation 679 / 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec 42 shall apply fully and without exception to the processing of personal data affected by this regulation . __________________ oj l 119 , 4 . 5 . 2016 , p . 1 - 88 .


### “long - term care benefit” means any benefit in kind , cash or a combination of both for persons who , over an extended period of time , on account of old - age , disability , illness or impairment , require considerable assistance from another person or persons to carry out essential daily activities , including to support their personal autonomy ; this includes benefits granted to or for the person providing such assistance ; ### ‘ long - term care benefit’ means any benefit in kind , cash or a combination of both for persons who , over an extended period of time , on account of old - age , disability , illness or impairment , require assistance from another person or persons to carry out essential daily activities , including to support their personal autonomy ; this includes benefits granted to or for the person providing such assistance ;


### for the purposes of this title , an activity as an employed or self - employed person normally pursued on board a vessel at sea flying the flag of a member state shall be deemed to be an activity pursued in the said member state . however , a person employed on board a vessel flying the flag of a member state and remunerated for such activity by an undertaking or a person whose registered office or place of business is in another member state shall be subject to the legislation of the latter member state if he resides in that state . the undertaking or person paying the remuneration shall be considered as the employer for the purposes of the said legislation . ### paragraph 4 is replaced with the following : 4 . for the purposes of this title , an activity as an employed or self - employed person normally pursued on board a vessel at sea flying the flag of a member state shall be deemed to be an activity pursued in the said member state . however , a person employed on board a vessel flying the flag of a member state and remunerated for such activity by an employer whose registered office is in another member state shall be subject to the legislation of the latter member state if he resides in that state .


### ' 5 . an activity as a flight crew or cabin crew member performing air passenger or freight services shall be deemed to be an activity pursued exclusively in the member state where the home base , as defined in annex iii , subpart ftl to commission regulation no 965 / 2012 of 5 october 2012 laying down technical requirements and administrative procedures related to air operations pursuant to regulation no 216 / 2008 of the european parliament and the council as amended by commission regulation no 83 / 2014 / eu of 29 january 2014 , is located45 . ' __________________ 45oj l 28 , 31 . 01 . 2014 , p . 17 ### ' 5 . an activity as a flight crew or cabin crew member performing air passenger or freight services shall be deemed to be an activity pursued in the member state where the home base , as defined in annex iii to commission regulation no 965 / 2012 of 5 october 2012 laying down technical requirements and administrative procedures related to air operations pursuant to regulation no 216 / 2008 of the european parliament and the council as amended by commission regulation no 83 / 2014 / eu of 29 january 2014 , is located45 . ' however , a member of a flight crew or cabin crew carrying out , over a period of 12 months , most of his or her duties as a crew member in service within the meaning of item 17 of paragraph oro . ftl . 105 of annex ii to regulation no 83 / 2014 , in the context of a scheduled flight mission on board an aircraft from a member state other than that in which his or her home base is located , shall be subject to the legislation of former of the two member states . __________________ 45oj l 28 , 31 . 01 . 2014 , p . 17


### present text a person who normally pursues an activity as an employed person in two or more member states shall be subject : to the legislation of the member state of residence if he / she pursues a substantial part of his / her activity in that member state ; or if he / she does not pursue a substantial part of his / her activity in the member state of residence : to the legislation of the member state in which the registered office or place of business of the undertaking or employer is situated if he / she is employed by one undertaking or employer ; or to the legislation of the member state in which the registered office or place of business of the undertakings or employers is situated if he / she is employed by two or more undertakings or employers which have their registered office or place of business in only one member state ; or to the legislation of the member state in which the registered office or place of business of the undertaking or employer is situated other than the member state of residence if he / she is employed by two or more undertakings or employers , which have their registered office or place of business in two member states , one of which is the member state of residence ; or to the legislation of the member state of residence if he / she is employed by two or more undertakings or employers , at least two of which have their registered office or place of business in different member states other than the member state of residence . ### in article 13 , paragraph 1 is replaced by the following : a person who normally pursues an activity as an employed person in two or more member states shall be subject : to the legislation of the member state of residence if he / she pursues a substantial part of his / her activity in that member state ; or if he / she does not pursue a substantial part of his / her activity in the member state of residence : to the legislation of the member state in which the registered office of the undertaking or employer is / are situated and the undertaking / employer pursue substantial activity if he / she is employed by one undertaking or employer or more than one undertaking or employer situated in the same member state ; or to the legislation of the member state in which the employee predominantly pursues his / her activity or activities in situations where is not applicable .


### the competent institution of a member state whose legislation provides for the calculation of benefits on the basis of the amount of the previous salary or professional income shall take into account exclusively the salary or professional income received by the person concerned in respect of his / her last activity as an employed or self - employed person under the said legislation . ### in article 62 , paragraph 1 is replaced by the following : “1 . the competent institution of a member state whose legislation provides for the calculation of benefits on the basis of the amount of the previous salary or professional income shall take into account the salary or professional income received by the person concerned in respect of his / her last activity or activities as an employed or self - employed person under the said legislation . '


### the competent authorities shall ensure that their institutions are aware of and apply all provisions , legislative or otherwise , including the decisions of the administrative commission , in the areas covered by and within the terms of this regulation and the implementing regulation . ### the competent authorities shall in accordance with their national law and / or practice , ensure that their relevant institutions are informed of and apply all provisions , legislative or otherwise , including the decisions of the administrative commission , in the areas covered by and within the terms of this regulation and the implementing regulation .


### in order to ensure the correct determination of the applicable legislation , the competent authorities shall promote the cooperation between institutions and labour inspectorates in their member states . ### in order to ensure the correct determination of the applicable legislation , the competent authorities shall promote cooperation between the institutions concerned , such as the labour inspectorates in their member states .


### in order to protect the rights of the persons concerned member states should ensure that any data requests and responses are necessary and proportionate for the proper implementation of regulation no 883 / 2004 and this regulation , in accordance with european data protection legislation . there should be no automatic removal of benefit entitlement resulting from the data exchange , and any decision taken on the basis of the data exchange should respect the fundamental rights and freedoms of the individual concerned in that it is based on sufficient evidence and is subject to a fair appeal procedure . ### in order to protect the rights of the persons concerned member states should ensure that any data requests and responses are necessary and proportionate for the proper implementation of regulation no 883 / 2004 and this regulation , in accordance with european data protection legislation . the relevant eu data protection acquis , in particular regulation 679 / 2016 of the european parliament and of the council* shall apply to the processing of personal data pursuant to this regulation . there should be no automatic removal of benefit entitlement resulting from the data exchange , and any decision taken on the basis of the data exchange should respect the fundamental rights and freedoms of the individual concerned in that it is based on sufficient evidence and is subject to a fair appeal procedure . _________________ * regulation 679 / 2016 of the european parliament and of the council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec .


### “ ‘ fraud’ means any intentional act or omission to act , in order to obtain or receive social security benefits or to avoid to pay social security contributions , contrary to the law of a member state ; ” . ### “ ‘ fraud’ means any intentional act or omission to act , in order to obtain or receive social security benefits or to avoid to pay social security contributions or circumvent the rules governing membership of a member state social security scheme to the detriment of persons or institutions , contrary to the law of a member state ; ” .


### ‘ fraud’ means any intentional act or omission to act , in order to obtain or receive social security benefits or to avoid to pay social security contributions , contrary to the law of a member state ; . ### ‘ fraud’ means any intentional act or omission to act , causing prejudice to institutions in order to obtain or receive social security benefits or to avoid paying social security contributions or to circumvent the membership rules of a member state’s social security scheme , contrary to the law of the member state , the basic regulation or the implementing regulation


### the administrative commission shall draw up a detailed list of the types of data requests and responses which can be made under paragraph 5 and the european commission shall give such list the necessary publicity . only data requests and responses which are listed shall be permitted . ### the administrative commission shall draw up a detailed list of the types of data requests and responses which can be made under paragraph 5 , identify which entities are to be entitled to make such requests and establish the applicable procedures and safeguards . the european commission shall give such list the necessary publicity . only data requests and responses which are listed shall be permitted .


### documents issued by the institution of a member state and showing the position of a person for the purposes of the application of the basic regulation and of the implementing regulation , and supporting evidence on the basis of which the documents have been issued , shall be accepted by the institutions of the other member states for as long as they have not been withdrawn or declared to be invalid by the member state in which they were issued . such documents shall only be valid if all sections indicated as compulsory are filled in . ### documents issued by the institution of a member state and showing the position of a person for the purposes of the application of the basic regulation and of the implementing regulation , and supporting evidence on the basis of which the documents have been issued , shall be accepted by the institutions of the other member states for as long as they have not been withdrawn or declared to be invalid by the member state in which they were issued or qualified as a fraudulent document pursuant article 5a . such documents shall only be valid if all sections indicated as compulsory are filled in .


### where no agreement is reached between the institutions or authorities concerned , the matter may be brought before the administrative commission by the competent authorities no earlier than one month after the date on which the difference of views , as referred to in paragraph 1 or 2 arose . the administrative commission shall seek to reconcile the points of view within six months of the date on which the matter was brought before it . ### 7 a . in article 6 , paragraph 3 is replaced by the following : 3 . where no agreement is reached between the institutions or authorities concerned within three months of the date on which the difference of views arises , the matter shall be brought before the administrative commission by the competent authorities no earlier than one month after the date on which the difference of views , as referred to in paragraph 1 or 2 arose . the administrative commission shall seek to reconcile the points of view within six months of the date on which the matter was brought before it .


### where there is a difference of views between the institutions of two or more member states about the determination of the residence of a person to whom the basic regulation applies , these institutions shall establish by common agreement the centre of interests of the person concerned , based on an overall assessment of all available information relating to relevant facts , which may include , as appropriate : ### 7 c . in article 11 , paragraph 1 is replaced by the following : where there is a difference of views between the institutions of two or more member states about the determination of the residence of a person to whom the basic regulation applies , these institutions shall , no later than three months after the difference of views arises , establish by common agreement the centre of interests of the person concerned , based on an overall assessment of all available information relating to relevant facts , which may include , as appropriate :


### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is posted within the meaning of the directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services52 or sent by that employer to another member state ' shall include a person who is recruited with a view to being posted or sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation . . __________________ 52 oj l 018 , 21 . 01 . 1997 p . 1 . ### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is sent by that employer to another member state ' shall include a person who is recruited with a view to being posted or sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation .


### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is posted within the meaning of the directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services52 or sent by that employer to another member state ' shall include a person who is recruited with a view to being posted or sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation . . __________________ 52 oj l 018 , 21 . 01 . 1997 p . 1 . ### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is posted by that employer to another member state ' shall include a person who is recruited with a view to being posted or sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation .


### for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ### paragraph 2 is replaced by the following : “2 . for the purposes of the application of article 12 of the basic regulation , the phrase ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which he is established , taking into account the criteria defining the activities carried out by the undertaking in question , such as the turnover achieved in the posting state where such turnover is at least 25 % of the total turnover from the previous 12 months . however , in the case of a newly established undertaking , the turnover from the time they commenced the business would be more appropriate . the relevant criteria must be adapted to the specific characteristics of each employer and the nature of the activities carried out . ”


### for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ### paragraph 2 is replaced by the following : ' 2 . for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out and shall include at least : the place where posted workers are recruited and from which they are posted ; the law applicable to the contracts concluded by the undertaking with its workers , on the one hand , and with its clients , on the other ; the place where the undertaking performs its substantial business activity and where it employs administrative staff ; the number of contracts performed and / or the size of the turnover realised in the member state of establishment , taking into account the specific situation of , inter alia , newly established undertakings and smes . '


### for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ### paragraph 2 is replaced by the following : ‘ 2 . for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question , including those listed - non - exhaustively - in article 4 of directive 2014 / 67 / eu on the enforcement of directive 96 / 71 / ec on the posting of workers in the framework of the provision of services ; the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ’


### for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ### paragraph 2 is replaced by the following : “2 . for the purposes of the application of article 12 of the basic regulation , the words ‘ which normally carries out its activities there’ shall refer to an employer that ordinarily performs substantial activities , other than purely internal management activities , in the territory of the member state in which it is established , taking account of all criteria characterising the activities carried out by the undertaking in question , such as the turnover achieved in the posting state where such turnover is at least 25 % of the total annual turnover . the relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out . ”


### for the purposes of the application of article 12 of the basic regulation , the words ‘ who normally pursues an activity as a self - employed person’ shall refer to a person who habitually carries out substantial activities in the territory of the member state in which he is established . in particular , that person must have already pursued his activity for some time before the date when he wishes to take advantage of the provisions of that article and , during any period of temporary activity in another member state , must continue to fulfil , in the member state where he is established , the requirements for the pursuit of his activity in order to be able to pursue it on his return . ### paragraph 3 is replaced by the following : “3 . for the purposes of the application of article 12 of the basic regulation , the words ‘ who normally pursues an activity as a self - employed person’ shall refer to a person who habitually carries out substantial activities in the territory of the member state in which he is established . in particular , that person must have already pursued a sufficient activity for some time before the date when he wishes to take advantage of the provisions of that article and , during any period of temporary activity in another member state , must continue to fulfil , in the member state where he is established , the requirements for the pursuit of his activity in order to be able to pursue it on his return . ”


### for the determination of the applicable legislation under paragraphs 8 and 9 , the institutions concerned shall take into account the situation projected for the following 12 calendar months . ### paragraph 10 is replaced by the following : 10 . the determination of applicable legislation under article 13 of the basic regulation shall apply for a maximum period of 24 months . after expiry of the 24 - month period , the determination shall be revised on the basis of the person ' s situation .


### for the determination of the applicable legislation under paragraphs 8 and 9 , the institutions concerned shall take into account the situation projected for the following 12 calendar months . ### paragraph 10 is replaced by the following : “10 . ' the determination of applicable legislation under article 13 of regulation 883 / 2004 shall apply for a maximum period of 12 months . after expiry of the 12 - month period , the determination shall be revised on the basis of the person ' s situation . ”


### unless otherwise provided for by article 16 of the implementing regulation , where a person pursues his activity in a member state other than the member state competent under title ii of the basic regulation , the employer or , in the case of a person who does not pursue an activity as an employed person , the person concerned shall inform the competent institution of the member state whose legislation is applicable thereof , whenever possible in advance . that institution shall without delay make information concerning the legislation applicable to the person concerned , pursuant to article 11 or article 12 of the basic regulation , available to the person concerned and to the institution designated by the competent authority of the member state in which the activity is pursued . ### in article 15 , paragraph 1 is replaced with the following : ‘ 1 . unless otherwise provided for by article 16 of the implementing regulation , where a person pursues his activity in a member state other than the member state competent under title ii of the basic regulation , the employer or , in the case of a person who does not pursue an activity as an employed person , the person concerned shall inform the competent institution of the member state whose legislation is applicable thereof , in advance . that institution shall without delay make information concerning the legislation applicable to the person concerned , pursuant to article 11 or article 12 or article 13 of the basic regulation , available to the person concerned and to the institution designated by the competent authority of the member state in which the activity is pursued . ’


### where necessary for the exercise of legislative powers at national or union level , relevant information regarding the social security rights and obligations of the persons concerned shall be exchanged directly between the competent institutions and the labour inspectorates , immigration or tax authorities of the states concerned this may include the processing of personal data for purposes other than the exercise or enforcement of rights and obligations under the basic regulation and this regulation in particular to ensure compliance with relevant legal obligations in the fields of labour , health and safety , immigration and taxation law . further details shall be laid down by decision of the administrative commission . ### where necessary for the exercise of legislative powers at national or union level , relevant information regarding the social security rights and obligations of the persons concerned shall be exchanged directly between the competent institutions and the labour inspectorates , immigration or tax authorities of the states concerned this may include the processing of personal data for purposes other than the exercise or enforcement of rights and obligations under the basic regulation and this regulation in particular to ensure compliance with relevant legal obligations in the fields of labour , health and safety , immigration and taxation law . the authorities responsible for the social security data shall inform data subjects of the transfer of those data to another public administrative body and of the purpose of the further processing , in accordance with the principle of fair processing set in article 6 of directive 95 / 46 / ec of the european parliament and of the council* and article 5of regulation 679 / 2016 of the european parliament and of the council** . the authorities to which the social security data are transferred shall inform the data subjects of its identity , the purpose of the processing and the categories of data processed in accordance with article 11 , and of directive 95 / 46 / ec and with article 14 of regulation 679 / 216 . further details shall be laid down by decision of the administrative commission . _____________ * . directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data . **b regulation 679 / 2016 of the european parliament and of the council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec .


### the relevant institutions shall communicate to the competent institution of the member state whose legislation is applicable to a person pursuant to title ii of the basic regulation the necessary information required to establish the date on which that legislation becomes applicable and the contributions which that person and his employer are liable to pay under that legislation . ### in article 20 , paragraph 1 shall be replaced by the following : ‘ 1 . the relevant institutions shall communicate to the competent institution of the member state whose legislation is applicable to a person pursuant to title ii of the basic regulation the necessary information required to establish the date on which that legislation becomes applicable and the contributions which that person and his employer are liable to pay under that legislation and directive 96 / 71 / ec for calculating the contributions on the basis of the remuneration paid . ’


### by agreement between the applicant party and the requested party and in accordance with the arrangements laid down by the requested party , officials authorised by the applicant party may , with a view to promoting mutual assistance provided for in this section : ### by agreement between the applicant party and the requested party and in accordance with the arrangements laid down by the requested party , officials and responsible office - holders authorised by the applicant party or by the european labour authority may , with a view to promoting mutual assistance provided for in this section :


### be present during administrative enquiries carried out in the territory of the member state of the requested party ; ### be present during administrative enquiries carried out in the territory of the member state of the requested party and / or the applicant party ;


### in so far as it is permitted under the legislation in force in the member state of the requested party , the agreement referred to in paragraph 1 may provide that officials of the member state of applicant party may interview individuals and examine records . ### in so far as it is permitted under the legislation in force in the member state of the requested party , the agreement referred to in paragraph 1 may provide that officials or responsible office - holders of the member state of the applicant party and , if necessary , by the european labour authority , may interview individuals and examine records .


### to deliver scientific , economic and societal impact in pursuit of this general objective , the union should invest in research and innovation through horizon europe - a framework programme for research and innovation 2021 - 2027 to support the creation and diffusion of high - quality knowledge and technologies , to strengthen the impact of research and innovation in developing , supporting and implementing union policies , to support the uptake of innovative solutions in industry and society to address global challenges and promote industrial competitiveness ; to foster all forms of innovation , including breakthrough innovation , and strengthen market deployment of innovative solutions ; and optimise the delivery of such investment for increased impact within a strengthened european research area . ### to deliver scientific , economic and societal impact in pursuit of this general objective , the union should invest in research and innovation through horizon europe - a framework programme for research and innovation 2021 - 2027 to support the creation , diffusion and transfer of high - quality knowledge and technologies , to strengthen the impact of research and innovation in addressing global societal challenges as defined by the sustainable development goals , and in developing , supporting and implementing union policies , to support the uptake of innovative solutions in industry and society to address global challenges and promote industrial competitiveness ; to foster all forms of innovation , including breakthrough innovation , and strengthen market deployment of innovative solutions ; and optimise the delivery of such investment for increased impact within a strengthened european research area .


### the programme should seek synergies with other union programmes , from their design and strategic planning , to project selection , management , communication , dissemination and exploitation of results , to monitoring , auditing and governance . with a view to avoiding overlaps and duplication and increasing the leverage of union funding , transfers from other union programmes to horizon europe activities can take place . in such cases they will follow horizon europe rules . ### the programme should seek synergies with other union programmes , from their design and strategic planning , to project selection , management , communication , dissemination and exploitation of results , to monitoring , auditing and governance . with a view to avoiding overlaps and duplication , it is necessary to verify interaction with other programmes . in order to increase the leverage of union funding , transfers from other union programmes to horizon europe activities can take place . in such cases they will follow horizon europe rules .


### pursuant to article 349 of the tfeu , the union ' s outermost regions are entitled to specific measures regarding access to horizontal union programmes . the programme should therefore take into account the specific characteristics of those regions in line with the commission ' s communication on ' a stronger and renewed strategic partnership with the eu ' s outermost regions ' 623 final ) as endorsed by the council on 12 april 2018 . ### pursuant to article 349 of the tfeu , the union ' s outermost regions are entitled to specific measures regarding access to horizontal union programmes . the programme should therefore take into account the specific characteristics of those regions in line with the commission ' s communication on ' a stronger and renewed strategic partnership with the eu ' s outermost regions ' 623 final ) as endorsed by the council on 12 april 2018 . less developed regions will be also considered in some parts of horizon europe as for example in the sharing excellence programme . the criteria for selecting these regions should consider the criteria of european structural and investment funds and the innovation scoreboard regional indicator .


### the programme ' s general objective is to deliver scientific , economic and societal impact from the union ' s investments in research and innovation so as to strengthen the scientific and technological bases of the union and foster its competitiveness , including in its industry , deliver on the union strategic priorities , and contribute to tackling global challenges , including the sustainable development goals . ### the programme ' s general objective is to deliver scientific , economic and societal impact from the union ' s investments in research and innovation so as to strengthen the scientific and technological bases of the union and foster its competitiveness in all member states , including in its industry , deliver on the union strategic priorities , and contribute to tackling global challenges , as set out in the sustainable development goals .


### the financial envelope for the implementation of the framework programme for the period 2021 &#8211 ; 2027 shall be eur 94 100 000 000 in current prices for the specific programme referred to in article 1 and , in addition , the amount for the specific programme referred to in article 1 , as laid down in regulation&#8230 ; . establishing the european defence fund . ### the financial envelope for the implementation of the framework programme for the period 2021 &#8211 ; 2027 shall be eur 120 000 000 000 in constant prices [ eur 135 248 000000 in current prices ] for the specific programme referred to in article 1 and , in addition , the amount for the specific programme referred to in article 1 , as laid down in regulation&#8230 ; . establishing the european defence fund .


### eur 2 200 000 000 for the non - nuclear direct actions of the joint research centre ; ### 2 . 338 % of the amount referred to in paragraph1 , first half sentence , for the non - nuclear direct actions of the joint research centre ;


### eur 10 500 000 000 for the european innovation council , including up to eur 500 000 000 for european innovation ecosystems ; ### 158 % of the amount referred to in paragraph1 , first half sentence , for the european innovation council , including up to 0 . 531 % of the amount referred to in paragraph 1 , first half sentence , for european innovation ecosystems ; ;


### areas of intervention : environmental observation ; biodiversity and natural capital ; agriculture , forestry and rural areas ; sea and oceans ; food systems ; bio - based innovation systems ; circular systems ### areas of intervention : environmental observation ; biodiversity and natural capital ; agriculture , forestry and rural areas ; sea , oceans and blue economy ; food systems ; bio - based innovation systems ; circular systems


### through the following activities , this part will , in line with article 4 , optimise the programme ' s delivery for increased impact within a strengthened european research area . it will also support the programme ' s other specific objectives as described in article 3 . while underpinning the entire programme , this part will support activities that contribute to a more knowledge - based and innovative and gender - equal europe , at the front edge of global competition , thereby optimising national strengths and potential across europe in a well - performing european research area , where knowledge and a highly skilled workforce circulate freely , where the outcomes of r&i are understood and trusted by informed citizens and benefit society as a whole , and where eu policy , notably r&i policy , is based on high quality scientific evidence . ### through the following activities , this part will , in line with article 4 , optimise the programme ' s delivery for increased impact within a strengthened european research area . it will also support the programme ' s other specific objectives as described in article 3 . while underpinning the entire programme , this part will support activities that build effective and sustained cooperation between science and society , combat fake news , recruit new talent for science and innovation , promote gender equality and pair scientific excellence with excellence in science engagement and with social awareness and responsibility . it will contribute to an increased scientific , technical and media literate society , to a more knowledge - based and innovative and gender - equal europe , at the front edge of global competition , thereby optimising national strengths and potential across europe in a well - performing european research area , where knowledge and a highly skilled workforce circulate freely , where the processes and the outcomes of r&i are shared with society for its benefit and where eu policy , notably r&i policy , is based on high quality scientific evidence . .


### evidence that the european partnership is more effective in achieving the related objectives of the programme , in particular in delivering clear impacts for the eu and its citizens , notably in view of delivering on global challenges and research and innovation objectives , securing eu competitiveness and contributing to the strengthening of the european research and innovation area and international commitments ; ### evidence that the european partnership is more effective in achieving the related objectives of the programme , in particular in delivering clear impacts for the eu and its citizens , notably in view of delivering on global challenges including the sustainable development goals&#160 ; and research and innovation objectives , securing eu competitiveness and contributing to the strengthening of the european research and innovation area and international commitments ;


### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell prescription and non - prescription veterinary medicinal products via the internet to buyers in other member states . ### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons - where appropriate , veterinarians - who are authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell prescription and non - prescription veterinary medicinal products via the internet to buyers in other member states .


### ‘ antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species ; ### ‘ antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to halt the growth of or kill microorganisms of the same species ;


### applications shall be submitted electronically . for applications submitted in accordance with the centralised marketing authorisation procedure , the formats made available by the agency shall be used . ### applications shall be submitted electronically via a single electronic portal . for all types of applications submitted in accordance with this regulation , the formats made available by the agency shall be used .


### the outer packaging of a veterinary medicinal product shall contain only the following information : ### the outer packaging of a veterinary medicinal product shall contain at least the following information :


### by way of derogation from article 5 , a marketing authorisation for a limited market shall be granted for a period of 3 years . ### by way of derogation from article 5 , a marketing authorisation for a limited market shall be valid for an unlimited period of time , unless risks to animal health , public health and protection of the environment are detected .


### by way of derogation from article 5 , a marketing authorisation for a limited market shall be granted for a period of 3 years . ### by way of derogation from article 5 , a marketing authorisation for a limited market shall be granted for a period of 3 years . at the end of that period , the holder may request , in the light of scientific data and on grounds of pharmacovigilance and efficiency , that this authorisation be converted into an open - ended authorisation .


### the commission , taking into account the state of animal and public health in the union , shall be empowered to adopt delegated acts in accordance with article 146 in order to amend the list set out in paragraph 2 . ### .


### any environmental incidents observed following administration of a veterinary medicinal product to an animal ; ### any environmental incidents observed following administration of a veterinary medicinal product to an animal , including incidents of leakage of antibiotic residues into soil and water ;


### identification of the animal under treatment ; ### identification of the animal or group of animals under treatment ;


### where a veterinary medicinal product is supplied on prescription , the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned . ### where a veterinary medicinal product is prescribed on prescription , the quantity prescribed shall be restricted to the amount required for the treatment or therapy concerned and take account of the presentations available on the market . prophylactic use of anti - bacterials shall not be authorised except in cases where said use is expressly authorised by the summary of technical characteristics of the veterinary medicinal product , drawn up in accordance with this regulation .


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with the following :


### if there is no product as referred to in point , a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation . ### a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no 726 / 2004 , or


### the prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products . ### the prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to use , prescribe or supply veterinary medicinal products .


### this regulation constitutes an essential step towards the completion of the capital markets union as set out in the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions , entitled ' action plan on building a capital markets union ' of 30 september 2015 . the aim of the capital markets union is to help businesses tap into more diverse sources of capital from anywhere within the european union , make markets work more efficiently and offer investors and savers additional opportunities to put their money to work , in order to enhance growth and create jobs . ### this regulation constitutes an essential step towards the completion of the capital markets union as set out in the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions , entitled ' action plan on building a capital markets union ' of 30 september 2015 . the aim of the capital markets union is to help businesses tap into more diverse sources of capital from anywhere within the european union , make markets work more efficiently and offer investors and savers additional opportunities to put their money to work , in order to enhance growth and create jobs , in particular for smes ;


### the aim of this regulation is to ensure investor protection and market efficiency , while enhancing the single market for capital . the provision of information which , according to the nature of the issuer and of the securities , is necessary to enable investors to make an informed investment decision ensures , together with rules on the conduct of business , the protection of investors . moreover , such information provides an effective means of increasing confidence in securities and thus of contributing to the proper functioning and development of securities markets . the appropriate way to make this information available is to publish a prospectus . ### the aim of this regulation is to ensure investor protection and market efficiency , while enhancing the single market for capital and facilitating the access of smes to it . the provision of information which , according to the nature of the issuer and of the securities , is necessary to enable investors to make an informed investment decision ensures , together with rules on the conduct of business , the protection of investors . moreover , such information provides an effective means of increasing confidence in securities and thus of contributing to the proper functioning and development of securities markets . the appropriate way to make this information available is to publish a prospectus .


### the summary of the prospectus should be a useful source of information for investors , in particular retail investors . it should be a self - contained part of the prospectus and should focus on key information that investors need in order to be able to decide which offers and admissions to trading of securities to consider further . such key information should convey the essential characteristics of , and risks associated with , the issuer , any guarantor , and the securities offered or admitted to trading on a regulated market . it should also provide the general terms and conditions of the offer . in particular , the presentation of risk factors in the summary should consist of a limited selection of specific risks which the issuer considers to be the most material ones . ### the summary of the prospectus should be a useful source of information for investors , in particular retail investors . it should be a self - contained part of the prospectus and should focus on key information that investors need , based on the targets established by regulation no 1286 / 2014 of the european parliament and of the council on key information documents for packaged retail and insurance - based investment products , in order to be able to decide which offers and admissions to trading of securities to consider further . such key information should convey the essential characteristics of , and risks associated with , the issuer , any guarantor , and the securities offered or admitted to trading on a regulated market . it should also provide the general terms and conditions of the offer . in particular , the presentation of risk factors in the summary should consist of a limited selection of specific risks which the issuer considers to be the most material ones .


### the summary of the prospectus should be a useful source of information for investors , in particular retail investors . it should be a self - contained part of the prospectus and should focus on key information that investors need in order to be able to decide which offers and admissions to trading of securities to consider further . such key information should convey the essential characteristics of , and risks associated with , the issuer , any guarantor , and the securities offered or admitted to trading on a regulated market . it should also provide the general terms and conditions of the offer . in particular , the presentation of risk factors in the summary should consist of a limited selection of specific risks which the issuer considers to be the most material ones . ### the summary of the prospectus should be a useful source of information for investors , in particular retail investors and smes . it should be a self - contained part of the prospectus and should focus on key information that investors need in order to be able to decide which offers and admissions to trading of securities to consider further . such key information should convey the essential characteristics of , and risks associated with , the issuer , any guarantor , and the securities offered or admitted to trading on a regulated market . it should also provide the general terms and conditions of the offer . in particular , the presentation of risk factors in the summary should consist of a limited selection of specific risks which the issuer considers to be the most material ones .


### omission of sensitive information in a prospectus should be allowed in certain circumstances by means of a derogation granted by the competent authority in order to avoid detrimental situations for an issuer . ### omission of sensitive information in a prospectus should be allowed in certain circumstances by means of a derogation granted by the competent authority in order to avoid detrimental situations for an issuer , provided that the omission of such information is not likely to mislead the public with regard to facts and circumstances essential for an informed assessment of the issuer , offeror or guarantor .


### the content of the summary shall be accurate , fair , clear and not misleading . it shall be consistent with the other parts of the prospectus . ### the content of the summary shall be accurate , fair , clear and not misleading and containing all relevant information . it shall be consistent with the other parts of the prospectus .


### under a sub - section titled ' what are the key risks that are specific to the issuer ? ' a brief description of no more than five of the most material risk factors specific to the issuer contained in the category of highest materiality according to article 16 . ### under a sub - section titled ' what are the key risks that are specific to the issuer ? ' a brief and clear description of no more than ten of the most material risk factors specific to the issuer contained in the category of highest materiality according to article 16 .


### under a sub - section titled ' what are the key risks that are specific to the securities ? ' a brief description of no more than five of the most material risk factors specific to the securities , contained in the category of highest materiality according to article 16 . ### under a sub - section titled ' what are the key risks that are specific to the securities ? ' a brief and clear description of no more than ten of the most material risk factors specific to the securities , contained in the category of highest materiality according to article 16 .


### the risk factors featured in a prospectus shall be limited to risks which are specific to the issuer and / or the securities and are material for taking an informed investment decision , as corroborated by the content of the registration document and the securities note . they shall be allocated across a maximum of three distinct categories which shall differentiate them by their relative materiality based on the issuer ' s assessment of the probability of their occurrence and the expected magnitude of their negative impact . ### the risk factors featured in a prospectus shall include all risks which are specific to the issuer and the securities and are material for taking an informed investment decision , as corroborated by the content of the registration document and the securities note . they shall be allocated across a maximum of three distinct categories which shall differentiate them by their relative materiality based on the issuer ' s assessment of the probability of their occurrence and the expected magnitude of their negative impact .


### the development of health technologies is a key driver of economic growth and innovation in the union . it forms part of an overall market for healthcare expenditure that accounts for 10% of eu gross domestic product . health technologies encompass medicinal products , medical devices and medical procedures , as well as measures for disease prevention , diagnosis or treatment . ### the development of health technologies is a key to improving health policies through access to more progressive health technologies , and thus achieving a high level of health protection . at the same time , health technologies are an innovative sector of the economy which forms part of an overall market for healthcare expenditure that accounts for 10% of eu gross domestic product . health technologies encompass medicinal products , medical devices and medical procedures , as well as measures for disease prevention , diagnosis or treatment .


### the time - frame for joint clinical assessments for medicinal products should , in as far as possible , be fixed by reference to the time - frame applicable to the completion of the central marketing authorisation procedure provided for under regulation no 726 / 2004 . such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients . as a rule , the process should be completed by the time of the publication of the commission decision granting marketing authorisation . ### the time - frame for joint clinical assessments for medicinal products should be fixed by reference to the time - frame applicable to the completion of the central marketing authorisation procedure provided for under regulation no 726 / 2004 . such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients . as a rule , the process should be completed by the time of the publication of the commission decision granting marketing authorisation to avoid that the joint clinical assessments result in delays and may disadvantage the patient ' s access procedures .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , the commission should establish , by means of implementing acts , a common procedural framework for joint clinical assessments and joint scientific consultations , while the coordination group should establish a common methodological framework . where appropriate , and in justified cases , distinct rules must be developed for medicinal products and medical devices . in the development of such rules , the results of the work already undertaken in the eunethta joint actions , initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives may be taken into account . those powers should be exercised in accordance with regulation no 182 / 2011of the european parliament and of the council13 . the methodology should guarantee high quality and high clinical evidence . any flexibility in the methodology should be exceptional and adapted to very specific circumstances , but never to the detriment of the quality of health technologies or clinical evidence . clinical trials are the studies par excellence in the biomedical field , so the use of another type of study , for example , epidemiological studies , should be exceptional and fully justified . the rules to be developed in tertiary legislation should cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is needed . _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### members of the coordination group , and their appointed representatives shall respect the principles of independence , impartiality , and confidentiality . ### members of the coordination group , and their appointed representatives shall respect the principles of independence , impartiality , and confidentiality . transparency and publicity of the process is essential . in this connection , all clinical data being evaluated shall have the highest level of transparency and publicity in order to gain confidence in the system . in case there is confidential data for commercial reasons , the confidentiality needs to be clearly defined and justified and the confidential data well delimitated .


### the designated sub - group shall appoint , from among its members , an assessor and a co - assessor to conduct the joint clinical assessment . the appointments shall take into account the scientific expertise necessary for the assessment . ### the designated sub - group shall appoint , from among its members , an assessor and a co - assessor from different member state to conduct the joint clinical assessment . the appointments shall take into account the scientific expertise necessary for the assessment .


### the designated sub - group shall ensure that stakeholders , including patients and clinical experts , are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments . ### the designated sub - group shall ensure that stakeholders , including patients and clinical experts , civil society organisations , patient associations , social partners , consumer organisations , healthcare professionals and non - governmental organisations , are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments .


### the designated sub - group shall request the health technology developer to submit the documentation containing the information , data and evidence necessary for the joint scientific consultation . ### the designated sub - group shall request the health technology developer to submit the documentation containing the information , data and evidence necessary for the joint scientific consultation . all relevant data and information shall be available to the public .


### the designated sub - group shall appoint from among its members , an assessor and a co - assessor , with responsibility for conducting the joint scientific consultation . the appointments shall take into account the scientific expertise necessary for the assessment . ### the designated sub - group shall appoint from among its members , an assessor and a co - assessor , from different member states , with responsibility for conducting the joint scientific consultation . the appointments shall take into account the scientific expertise necessary for the assessment .


### the coordination group shall approve the final joint scientific consultation report , wherever possible by consensus or , where necessary , by a simple majority of member states , at the latest 100 days following the start of the preparation of the report referred to in paragraph 4 . ### the coordination group shall approve the final joint scientific consultation report , wherever possible by consensus or , where necessary , by a simple majority of member states , at the latest 90 days following the start of the preparation of the report referred to in paragraph 4 .


### the consultation of patients , clinical experts , and other stakeholders in clinical assessments . ### the consultation of patients , clinical experts , and other stakeholders such as civil society organisations , patient associations , social partners , consumer organisations , healthcare professionals and non - governmental organisations in clinical assessments ;


### the funding referred to in paragraph 1 shall include funding for the participation of member states ' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations . assessor and co - assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal commission provisions . ### the funding referred to in paragraph 1 shall include funding for the participation of member states ' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations . assessor and co - assessors shall be entitled to a special allowance , approved by the commission , compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal commission provisions .


### the commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications . ### the commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications . the stakeholder organisation shall at least have members of civil society organisations , patient associations , social partners , consumer organisations , healthcare professionals and non - governmental organisations dealing with health technology assessment .


### the commission shall organise ad - hoc meetings between the stakeholder network and the coordination group in order to : ### the commission shall organise meetings on a regular basis between the stakeholder network and the coordination group in order to :


### update stakeholders on the work of the group ; ### update stakeholders on the work of the group ; all members of the stakeholder network shall have access to all relevant data and information ;


### provide for an exchange of information on the work of the coordination group . ### provide for an exchange of information between the coordination group and the stakeholder network .


### no later than five years after the publication of the report referred to in article 28 , the commission shall carry out an evaluation of this regulation , and report on its conclusions . ### no later than&#160 ; four years after the publication of the report referred to in article 28 , the commission shall carry out an evaluation of this regulation , and report on its conclusions .


### in order to achieve eu air quality objectives and to ensure a continuous effort to reduce vehicle emissions , the power to adopt delegated 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 the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . 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 achieve union air quality objectives , as set out by the air quality standards and by the directive no 2008 / 50 of the european parliament and of the council1a , and to ensure a continuous effort to reduce vehicle emissions , the power to adopt delegated 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 the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . 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 . __________________ 1a directive 2008 / 50 / ec of the european parliament and of the council of 21 may 2008 on ambient air quality and cleaner air for europe .


### the manufacturer shall equip vehicles so that the components likely to affect emissions are designed , constructed and assembled so as to enable the vehicle , in normal use , to comply with this regulation and its implementing measures . ### article 5 is amended as follows : the manufacturer shall equip vehicles so that the components likely to affect emissions are designed , constructed and assembled so as to enable the vehicle , in normal use , to comply with this regulation and its implementing measures . when compliance factors are used in testing procedures measuring real life emissions , such cfs shall only reflect the uncertainty of the measuring devices . manufactures shall ensure effectiveness of emission control systems in respect with the limits also set out for nox and no2 .


### the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles . ### the increase of the limit value of total hydrocarbons emissions for positive ignition vehicles .


### public - public partnerships should aim to develop closer synergies , increase coordination and avoid unnecessary duplication with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles , in particular those relating to openness and transparency . ### public - public partnerships must aim to develop closer synergies , increase coordination and avoid unnecessary duplication and fragmentation with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles , in particular those relating to openness and transparency . a good , timely dissemination of comprehensive information together with the transparency of results and of the financial management are crucial for the success of prima .


### public - public partnerships should aim to develop closer synergies , increase coordination and avoid unnecessary duplication with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles , in particular those relating to openness and transparency . ### public - public partnerships should aim to develop closer synergies , increase coordination and avoid unnecessary duplication with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles , in particular those relating to openness , transparency , and accessibility .


### regulation no 1291 / 2013 acknowledges that international cooperation with third countries is necessary to address effectively common challenges . international cooperation in research and innovation is a key aspect of the union’s global commitments and has an important role to play in the union’s partnership with neighbourhood countries . this cooperation follows the approach taken in the european neighbourhood policy to differentiate the level of cooperation with each country in the neighbourhood based on their commitment towards the union . ### regulation no 1291 / 2013 acknowledges that international cooperation with third countries is necessary to address effectively common challenges . international cooperation in research and innovation is a key aspect of the union’s global commitments and has an important role to play in the union’s partnership with neighbourhood countries and with third countries . this cooperation follows the approach taken in the european neighbourhood policy to differentiate the level of cooperation with each country in the neighbourhood based on their commitment towards the union .


### prima aims at implementing a joint programme for the development and the adoption of innovative and integrated solutions for improving the efficiency , safety , security and sustainability of food production and water provision in the mediterranean area . prima should contribute to the achievement of the recently agreed sustainable development goals and to the forthcoming european sustainable development strategy . ### the lack of clean water and nutritious food has adverse effects on the health and stability of the populations , and prima aims at implementing a joint programme for the development and the adoption of innovative multi - dimensional and integrated common solutions for improving the efficiency , safety , security and sustainability of agri - food production and water provision , treatment and reuse in the mediterranean area based on principles of co - ownership , mutual interest and shared benefit . taking into account that access to water and sanitation constitutes a fundamental human right and since securing food and water availability is of paramount importance in the region , prima must contribute to the achievement of the recently agreed sustainable development goals and to the forthcoming european sustainable development strategy , as well as to contribute to the goals of the paris agreement .


### the commission should conduct an interim evaluation assessing in particular the quality and efficiency of prima and the progress made towards the objectives set , and a final evaluation , and should prepare reports on those evaluations . ### the commission taking into account the views of the participating states , should conduct an interim evaluation assessing in particular the quality and efficiency of prima and the progress made towards the objectives set , and a final evaluation , and should prepare reports on those evaluations .


### upon request from the commission , the prima - is and the participating states should submit any information the commission needs to include in the reports on the evaluation of prima . ### upon request from the commission , the prima - is and the participating states should submit any information the commission needs to include in the reports on the evaluation of prima . at the same time , such information should be transferred to the competent committees of the parliament .


### the objective of this decision is to strengthen the integration and alignment of research and innovation systems and activities in the mediterranean countries in the fields of water provision and food systems . the scale of the research and innovation necessary to address the challenges in the mediterranean area is immense due to the systemic character of the major bottlenecks . the scope of research and innovation is complex , multidisciplinary and requires a multi - actor and cross - border approach . a collaborative approach with a wide set of participating states can help to increase the required scale and scope , by pooling financial and intellectual resources . since the objective can therefore be better achieved at union level by integrating national efforts into a consistent union approach , by bringing together compartmentalised national research programmes , by helping design common research and funding strategies across national borders , and by achieving the critical mass of actors and investments required , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary in order to achieve those objectives . ### the objective of this decision is to strengthen the integration and alignment of research and innovation systems and activities in the mediterranean countries in the fields of water provision , its treatment , reuse , and sustainable use , and agri - food systems . the scale of the research and innovation necessary to address the challenges in the mediterranean area is immense due to the systemic character of the major bottlenecks . meanwhile , relevant results should be able to serve as a model in other , drought - hit areas of the union . the scope of research and innovation is complex , multidisciplinary and requires a multi - actor and cross - border approach . a collaborative approach with a wide set of participating states can help to increase the required scale and scope , by pooling financial and intellectual resources . since the objective can therefore be better achieved at union level by integrating national efforts into a consistent union approach , by bringing together compartmentalised national research programmes , by helping design common research and funding strategies across national borders , and by achieving the critical mass of actors and investments required , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary in order to achieve those objectives .