### proposal for a regulation of the european parliament and of the council on official controls and other official activities performed to ensure the application of food and feed law , rules on animal health and welfare , plant health , plant reproductive material , plant protection products and amending regulations no 999 / 2001 , 1829 / 2003 , 1831 / 2003 , 1 / 2005 , 396 / 2005 , 834 / 2007 , 1099 / 2009 , 1069 / 2009 , 1107 / 2009 , regulations no 1151 / 2012 , [ … . ] / 2013 [ office of publications , please insert number of regulation laying down provisions for the management of expenditure relating to the food chain , animal health and animal welfare , and relating to plant health and plant reproductive material ] , and directives 98 / 58 / ec , 1999 / 74 / ec , 2007 / 43 / ec , 2008 / 119 / ec , 2008 / 120 / ec and 2009 / 128 / ec ### proposal for a regulation of the european parliament and of the council on official controls and other official activities performed to ensure the application of food and feed law , rules on animal health and welfare and amending regulations no 999 / 2001 , 1829 / 2003 , 1831 / 2003 , 1 / 2005 , 396 / 2005 , 834 / 2007 , 1099 / 2009 , 1069 / 2009 , 1107 / 2009 , regulations no 1151 / 2012 , [ … . ] / 2013 [ office of publications , please insert number of regulation laying down provisions for the management of expenditure relating to the food chain , animal health and animal welfare , and relating to plant health and plant reproductive material ] , and directives 98 / 58 / ec , 1999 / 74 / ec , 2007 / 43 / ec , 2008 / 119 / ec , 2008 / 120 / ec and 2009 / 128 / ec


### measures to be taken on animals or goods entering the union from third countries presenting a risk ### measures to be taken in cases of an attempt to bring non - compliant consignments into the eu from third countries presenting a risk


### as appropriate , any such consignment shall be isolated or quarantined and animals belonging to it shall be kept and treated under appropriate conditions pending any further decision . ### as appropriate , any such consignment shall be isolated or quarantined and animals belonging to it shall be kept and treated under appropriate conditions pending any further decision . the special needs of other goods shall also be borne in mind .


### the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments . ### the information to be published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments .


### a member state shall immediately suspend the designation of a border control post and order its activities to be stopped , for all or for certain categories of animals and goods for which the designation was made , in cases where such activities may result in a risk to human , animal or plant health , animal welfare or , as regards gmos and plant protection products , to the environment . ### a member state shall immediately suspend the designation of a border control post and order its activities to be stopped , for all or for certain categories of animals and goods for which the designation was made , in cases where such activities may result in a risk to human or animal health or animal welfare .


### coordinating the application by the national reference laboratories and , if necessary , by other official laboratories of the methods referred to in point , in particular , by organising regular inter - laboratory comparative testing and by ensuring appropriate follow - up of such comparative testing in accordance , where available , with internationally accepted protocols ; ### coordinating the application by the national reference laboratories of the methods referred to in point , in particular , by organising regular inter - laboratory comparative testing and by ensuring appropriate follow - up of such comparative testing in accordance , where available , with internationally accepted protocols and informing the competent authorities of the follow - up and results of such inter - laboratory comparative testing ;


### member states shall consult the operators concerned on the methods used to calculate the fees provided for in article 77 . ### member states may consult the operators concerned on the methods used to calculate the fees provided for in article 77 .


### paragraphs 1 and 2 shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators , provided that the following conditions are met : ### paragraphs 1 and 2 shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators , while taking account of any current preliminary investigations or legal proceedings , provided that the following conditions are met :


### the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public , prior to the publication or release ; ### the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish prior to the publication or release ;


### the amount of the fees provided for in article 77 applied to each category of operators , and for each category of official controls ; ### the amount of the fees provided for in article 77 applied to each category of operators , and for official controls ;


### ' animals ' means animals as defined in point of article 4 of regulation no xxx / xxxx [ office of publications , please insert number of the regulation on animal health ] ; ### ' animals ' means animals as defined in point of article 4 of regulation no xxx / xxxx [ office of publications , please insert number of the regulation on animal health ] with the exception of ‘ pets’ ;


### governing food and food safety , at any stage of production , the processing and distribution of food , including rules aimed at guaranteeing fair practices in trade and protecting consumer interests and information , and the manufacture and use of materials and articles intended to come into contact with food ; ### governing food and food safety , at any stage of production , the processing and distribution of food , including rules aimed at guaranteeing commercial quality and fair practices in trade and protecting consumer interests and information , and the manufacture and use of materials and articles intended to come into contact with food ;


### the commission may organise training activities for the staff of the competent authorities and , where appropriate , for staff of other authorities of the member states involved in investigations of possible violations of the provisions of this regulation and of the rules referred to in article 1 . ### the commission shall organise training activities for the staff of the competent authorities and , where appropriate , for staff of other authorities of the member states involved in investigations of possible violations of the provisions of this regulation and of the rules referred to in article 1 .


### uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls , having regard , in addition to the criteria referred to in article 8 , to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes ; ### harmonised uniform specific requirements for the performance of official controls and the harmonised minimum frequency of such official controls , having regard , in addition to the criteria referred to in article 8 , to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes ;


### unless there is an overriding public interest in its disclosure , information covered by professional secrecy as referred to in paragraph 1 shall include information whose disclosure would undermine : ### unless there is an overriding public interest justifying its disclosure , information covered by professional secrecy as referred to in paragraph 1 shall include information whose disclosure would undermine :


### competent authorities shall charge fees to cover the additional costs they have incurred as a result of : ### competent authorities may charge fees to cover the additional costs they have incurred as a result of :


### where fees are calculated in accordance with point of paragraph 1 , the fees collected by competent authorities in accordance with article 77 shall not exceed the overall costs incurred for the official controls performed over the period of time referred to in point of paragraph 1 . ### the fees or contributions to costs collected by competent authorities in accordance with article 77 shall not exceed the overall costs incurred for the official controls performed over the period of time referred to in point of paragraph 1 .


### during official controls and other official activities , operators shall assist the staff of the competent authorities in the accomplishment of their tasks . ### during official controls and other official activities , operators shall assist the staff of the competent authorities in the accomplishment of their control tasks .


### the competent authorities of the border control post shall finalise the ched as soon as : ### the competent authorities of the border control post shall record the decision on the consignment in the common health entry document as soon as all official controls required by article 47 have been performed .


### fees collected in accordance with article 77 shall be : ### fees or contributions to costs collected in accordance with article 77 shall be levied taking into account : - the nature of the undertaking concerned and the associated risk factors ; - the interests of undertakings with small turnovers ; - traditional methods of production , processing and marketing ; the needs of undertakings situated in regions that are subject to special geographic constraints .


### the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments . ### the information which is published or made otherwise available to the public takes into account the observations expressed by the operator concerned or is published or released together with such observations .


### member states shall designate a single authority responsible for : ### member states shall designate the authority or authorities responsible for :


### member states shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities . ### member states shall ensure that adequate financial resources are available through public means to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities . fees or charges should be established only if the official control is performed exclusively in the interest of the food business operator .


### the hygiene of meat production ; ### the hygiene of meat production , covering at least : - the design and maintenance of premises and equipment ; - haccp - based pre - operational , operational , and post - operational principles , in particular to protect against microbiological , chemical , or physical hazards ; - personal hygiene ; - training in hygiene and work procedures ;


### that a sufficient number of other samples be taken for a second expert opinion ; or , ### that a sufficient number of samples be taken for a second expert opinion ; or


### where point of article 79 applies , the method used to adjust the level of the fees in accordance with article 80 ; ### the method used to adjust the level of the fees or the contribution to costs in accordance with articles 79 and 80 ;


### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities shall collect fees to recover the costs they incur in relation to : ### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities may collect fees or contributions to costs to recover the costs they incur in relation to :


### on animals and goods at all stages of production , processing and distribution ; ### on animals , plants , plant products , use of plant protection products and goods at all stages of production , processing , placing on the market and distribution ;


### carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes ; ### coordinating the carrying out of scientific and technical studies on the welfare of animals used for commercial or scientific purposes ;


### ' transhipment ' means the movement of goods subject to the official controls provided for in article 45 which arrive by sea or by air transport from a third country from a vessel or aircraft and are transported under customs supervision to another vessel or aircraft in the same port or airport in preparation for onward travel ; ### ' transhipment ' means the movement of goods or animals subject to the official controls provided for in article 45 which arrive by sea or by air transport from a third country from a vessel or aircraft and are transported under customs supervision to another vessel or aircraft in the same port or airport in preparation for onward travel ;


### multi - annual national control plans shall contain general information on the structure and organisation of the systems of official control in the member state concerned , and shall contain at least information on the following : ### multi - annual national control plans shall contain general information on the structure and organisation of the systems of official control in the member state concerned for each of the sectors concerned and shall contain at least information on the following :


### the commission may organise those activities in cooperation with member states . ### the commission shall organise those activities in cooperation with member states .


### the operator has requested such official controls . ### the operator is obliged to request such official controls .


### a member state shall immediately suspend the designation of a border control post and order its activities to be stopped , for all or for certain categories of animals and goods for which the designation was made , in cases where such activities may result in a risk to human , animal or plant health , animal welfare or , as regards gmos and plant protection products , to the environment . ### a member state shall immediately suspend the designation of a border control post and order its activities to be stopped , for all or for certain categories of animals and goods for which the designation was made , in cases where such activities may result in a risk to human or animal health or animal welfare .


### the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public , prior to the publication or release ; ### the operator concerned shall approve the information that the competent authority intends to publish or make otherwise available to the public , prior to the publication or release ;


### the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments . ### the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released simultaneously and together with such comments .


### the operator shall carry out all the measures ordered by the competent authorities in accordance with article 64 and and 65 without delay and , at the latest , within 60 days from the day on which the competent authorities notified the operator of their decision in accordance with article 64 . ### the operator shall carry out all the measures ordered by the competent authorities in accordance with article 64 and and 65 without delay and , at the latest , in the case of products , within 60 days from the day on which the competent authorities notified the operator of their decision in accordance with article 64 .


### member states shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities . ### member states shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities . with that aim in view they may collect fees or contributions to costs or make resources available from general tax revenue .


### official certificates shall be issued by the competent authorities . ### official certificates shall be issued by the competent authorities or delegated bodies pursuant to articles 25 to 32 .


### border control posts shall be located in the immediate vicinity of the point of entry into the union and in a place suitably equipped to be designated by the customs authorities in accordance with article 38 of regulation no 2913 / 92 . ### border control posts shall be located in the immediate vicinity of the point of entry into the union and in a place that is suitably equipped , in accordance with article 38 of regulation no 2913 / 92 .


### the performance of intensified official controls on animals , goods and operators for an appropriate period ; ### the performance of intensified official controls on animals , goods and operators for an appropriate period , in keeping with the nature of the risk ;


### their documents and any other relevant information . ### their relevant documents and any other relevant information and the control subjects listed in article 9 .


### shall indicate within ten days from the date of receipt of the notification : ### shall indicate within 15 working days from the date of receipt of the notification :


### destroy the consignment in compliance , where appropriate , with the rules referred to in article 1 ; or ### destroy the consignment or part thereof in compliance , where appropriate , with the rules referred to in article 1 ; or


### the method used to establish the fees provided for in article 77 , including the data and estimates used for the establishment of the flat rate fees referred to in point of article 79 ; ### the method used to establish the fees provided for in article 77 ;


### carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes ; ### coordinating the carrying out of scientific and technical studies on the welfare of animals used for commercial or scientific purposes ;


### give all necessary assistance and provide all documentation and other technical support that commission experts request to enable them to perform controls efficiently and effectively ; ### give necessary assistance and provide documentation and other technical support for commission experts to enable them to perform controls efficiently and effectively ;


### competent authorities shall perform official controls on all operators regularly , on a risk basis and with appropriate frequency , taking account of : ### competent authorities shall perform official controls on operators at suitable intervals , in line with the risks that may arise in relation to the area concerned , with appropriate frequency , and taking account of :


### member states shall ensure that statutory auditors and audit firms comply with international auditing standards when carrying out statutory audits as long as those standards are in conformity with the requirements of this directive and of regulation xx / xx . ### member states shall require that statutory auditors and audit firms comply with international auditing standards when carrying out statutory audits as long as those standards are in conformity with the requirements of this directive and of regulation xx / xx adopted according to paragraph 3 . member states shall require statutory auditors and audit firms to keep records of their work papers for at least five years in accordance with the rules on personal data protection and administrative and judicial proceedings .


### member states shall ensure that when carrying out a statutory audit , the statutory auditor and / or the audit firm and any holder of voting rights in the audit firm is independent of the audited entity and is not involved in the decision - taking of the audited entity . ' ### member states shall ensure that when carrying out a statutory audit , the statutory auditor and / or the audit firm takes all necessary steps to ensure that its independence is not compromised by financial , personal , business , employment or other relationships involving the statutory auditor , the audit firm , its affiliate firms and network and any natural person in a position to influence the outcome of the statutory audit .


### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european securities and markets authority and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities . ’ ### ‘ the competent bodies referred to in article 32 shall cooperate with a view to achieving a minimum convergence of the requirements set out in this article . they shall cooperate with esma in so far as such convergence relates to the statutory audits of public - interest entities . ’ .


### for the purposes of paragraph 1 , ' international auditing standards ' means international standards on auditing and related statement and standards which are part of the clarity project issued by the international federation of accountants in 2009 insofar as they are relevant to the statutory audit . ### for the purposes of paragraph 1 , ' international auditing standards ' means international standards on auditing and related statements and standards adopted and published by the international federation of accountants insofar as they are relevant to the statutory audit and are available in the working languages of the european union .


### the commission shall be empowered to adopt delegated acts in accordance with article 48a for the purpose of amending the definition of international auditing standards in paragraph 2 of this article . when using such powers , the commission shall take into account any amendments brought to the isas by the ifac , the opinion of the public interest oversight board on such amendments as well as any other developments in auditing and the audit profession . ### the commission shall be empowered to adopt delegated acts in accordance with article 48a for the purpose of adopting or revoking international auditing standards in paragraph 2 of this article . when using such powers , the commission shall decide on the applicability of international auditing standards within the union being aware of the proportionality of these standards . the commission shall adopt international auditing standards for application in the union only if they have been developed with proper due care , in a transparent manner , under public oversight and are generally accepted internationally ; they contribute a high level of credibility and quality to the annual or consolidated financial statements in conformity with the principles set out in article 4 of directive [ xxxx ] on the annual financial statements and the consolidated financial statements of certain types of undertakings ; are conducive to the union public good .


### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european securities and markets authority and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities . ’ ### ‘ the competent authorities referred to in article 32 shall cooperate with a view to achieving a minimum convergence of the requirements set out in this article . ’


### member states may impose audit procedures or requirements in addition to the international auditing standards only if those audit procedures or requirements stem from specific national legal requirements relating to the scope of statutory audits . member states shall ensure that those audit procedures or requirements comply with the following conditions : ### member states may impose audit procedures or requirements in addition to the international auditing standards only if those audit procedures or requirements stem from specific national legal requirements relating to the scope of statutory audits .


### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european securities and markets authority and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities . ’ ### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european group of auditors’ oversight bodies and the competent authorities referred to in article [ xxx ] regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audits of public - interest entities . ’ .


### the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european securities and markets authority and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities . ### the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with egaob and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities .


### member states shall ensure that the application of the auditing standards to the statutory audit of annual or consolidated financial statements of medium - sized undertakings is proportionate to the scale and complexity of the business of those undertakings . ### member states shall require the competent authorities in their jurisdiction to recognize , when overseeing the profession and in particular in relation to inspections , that the auditing standards adopted in accordance with article 26 are applied to the statutory audit of annual or consolidated financial statements in a manner that is proportionate to the scale and complexity of the business of the entity .


### adequate supervision of statutory auditors and audit firms that have cross - border activities or are part of networks requires the public oversight authorities of the member states to exchange information . in order to protect the confidentiality of the information that may be thus exchanged , member states should subject to the obligation of professional secrecy not only the employees of the public oversight authorities , but also all persons to whom the public oversight authorities have delegated tasks . the competent authority should have the possibility to delegate tasks to other authorities or bodies only with regard to the approval and registration of the statutory auditors . such delegation should be subject to several conditions and the competent authority should bear the ultimate responsibility for it . ### adequate supervision of statutory auditors and audit firms that have cross - border activities or are part of networks requires the public oversight authorities of the member states to exchange information . in order to protect the confidentiality of the information that may be thus exchanged , member states should subject to the obligation of professional secrecy not only the employees of the public oversight authorities , but also all persons to whom the public oversight authorities have delegated tasks . the competent authority should have the possibility to delegate tasks to other authorities or bodies with regard to the inspections , verifications on regulatory proposals . such delegation should be subject to several conditions and the competent authority should bear the ultimate responsibility for it .


### adequate supervision of statutory auditors and audit firms that have cross - border activities or are part of networks requires the public oversight authorities of the member states to exchange information . in order to protect the confidentiality of the information that may be thus exchanged , member states should subject to the obligation of professional secrecy not only the employees of the public oversight authorities , but also all persons to whom the public oversight authorities have delegated tasks . the competent authority should have the possibility to delegate tasks to other authorities or bodies only with regard to the approval and registration of the statutory auditors . such delegation should be subject to several conditions and the competent authority should bear the ultimate responsibility for it . ### adequate supervision of statutory auditors and audit firms that have cross - border activities or are part of networks requires the public oversight authorities of the member states to exchange information . in order to protect the confidentiality of the information that may be thus exchanged , member states should subject to the obligation of professional secrecy not only the employees of the public oversight authorities , but also all persons to whom the public oversight authorities have delegated tasks . the competent authority should have the possibility to delegate tasks to other authorities or bodies with regard to the approval and registration of the statutory auditors and audit firms , including the education and qualifications of statutory auditors and the organisation of the register of statutory auditors and audit firms . such delegation should be subject to several conditions and the competent authority should bear the ultimate responsibility for it .


### entities governed by the law of a member state whose transferable securities are admitted to trading on a regulated market of any member state within the meaning of point 14 of article 4 of directive 2004 / 39 / ec ; ### entities governed by the law of a member state whose transferable securities are admitted to trading on a regulated market of any member state within the meaning of point 14 of article 4 of directive 2004 / 39 / ec , other than : captive insurance and captive reinsurance undertakings within the meaning of articles 13 and of directive 2009 / 138 / ec of the european parliament and of the council ; eu alternative investment funds as defined in article 4 of directive 2011 / 61 / ec of the european parliament and of the council ; undertakings for collective investment in transferable securities as defined in article 1 of directive 2009 / 65 / ec of the european parliament and of the council .


### regarding sea operations , specific requirements regarding the applicable jurisdiction and maritime law provisions concerning the geographical area where the joint operation takes place . ### regarding sea operations , the applicable jurisdiction and maritime law provisions concerning the geographical area where the joint operation takes place .


### the agency may itself initiate joint operations and pilot projects in cooperation with member states . ### the agency may itself initiate joint operations and pilot projects in cooperation with the member states involved and in agreement with the host member state and inform the european parliament via the agency ' s general report in accordance with article 20b .


### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation . the agency may also invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 . these representatives shall receive the appropriate training from the agency prior to their participation . ### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation with a view to improving their capacities , inter alia in the field of human rights . the agency shall ensure that assistance to operations within the framework of these projects is not provided to third countries where there are clear grounds for believing that such operations would lead to violations of fundamental rights . the agency may also invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 following an understanding with the host member state . these representatives shall receive the appropriate training from the agency prior to their participation , in particular in relation to fundamental rights .


### regarding sea operations , specific requirements regarding the applicable jurisdiction and maritime law provisions concerning the geographical area where the joint operation takes place . ### regarding sea operations , specific requirements regarding the applicable legislation and maritime law provisions concerning the geographical area where the joint operation takes place .


### the composition of the teams of guest officers ; ### the composition of the teams of guest officers and the deployment of other personnel ;


### the agency may deploy liaison officers , which should enjoy the highest possible protection to carry out their duties , in third countries . they shall form part of the local or regional cooperation networks of member states ' liaison officers set up pursuant to council regulation no 377 / 2004 . liaison officers shall only be deployed to third countries in which border management practices respect minimum human rights standards . priority for deployment should be given to those third countries , which on the basis of risk analysis constitute a country of origin or transit regarding illegal migration . on a reciprocal basis the agency may receive liaison officers posted by those third countries also , for a limited period of time . the management board shall adopt , on a proposal of the executive director , the list of priorities on a yearly basis in accordance with the provisions of article 24 . ### the agency may deploy liaison officers , which should enjoy the highest possible protection to carry out their duties , in third countries . they shall form part of the local or regional cooperation networks of member states ' liaison officers set up pursuant to council regulation no 377 / 2004 . liaison officers shall only be deployed to third countries with which it has concluded a working agreement in accordance with this article . priority for deployment should be given to those third countries , which on the basis of risk analysis constitute a country of origin or transit regarding illegal migration . on a reciprocal basis the agency may receive liaison officers posted by those third countries also , for a limited period of time . the management board shall adopt , on a proposal of the executive director , the list of priorities on a yearly basis in accordance with the provisions of article 24 .


### regarding sea operations , specific requirements regarding the applicable jurisdiction and maritime law provisions concerning the geographical area where the joint operation takes place . ### regarding sea operations , specific requirements regarding the applicable jurisdiction and maritime law provisions concerning the geographical area where the joint operation takes place , including reference to international and union law regarding interception , rescue at sea and disembarkation .


### compliance monitoring ### compliance monitoring and certification


### staff in charge of compliance monitoring ### recognised organisations and their staff in charge of compliance monitoring


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 18 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 18 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 24 months after publication ] ; the provisions necessary to comply with article 1 , and from [ insert concrete date 48 months after publication ] . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 6 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 6 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 6 months after publication ] ; the provisions necessary to comply with article 1 , and from [ insert concrete date 12 months after publication ] .


### persons trading medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply . they shall notify their activity to the competent authority of the member state where they are established . ### persons trading or brokering medicinal products shall ensure that the traded or brokered medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . they shall notify their activity to the competent authority of the member state where they are established , which shall inform the agency .


### persons trading medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply . they shall notify their activity to the competent authority of the member state where they are established . ### persons trading or brokering medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . they shall notify their activity to the competent authority of the member state where they are established , which shall inform the agency .


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of medicinal products should be established at community level . when introducing obligatory safety features for medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines , over - the - counter medicines and medicinal products sold directly by producers , without any intermediary , to clinical establishments in which the products are directly administered to the patient . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated .


### active substances used as starting material shall only be imported if : they have been manufactured by applying standards of good manufacturing practice at least equivalent to those laid down by the community ; and they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the community , and that the plant is subject to control and enforcement ensuring that those good manufacturing practices cannot be circumvented . ### active substances used as starting material may only be imported if : they have been manufactured by applying standards of good manufacturing practice at least equivalent to those laid down by the community ; and they have , in the past three years , successfully passed an inspection specifically covering active pharmaceutical ingredients carried out by a competent community authority or an authority of a country with which a mutual recognition agreement is in force . the passing of the inspection shall be documented by a certificate issued by a competent authority , attesting compliance with good manufacturing practice .


### safety features making it possible to ascertain identification , authenticity and traceability of medicinal products , other than radiopharmaceuticals , subject to medical prescription as defined in title vi . ### safety features making it possible to ascertain identification , authenticity and traceability of medicinal products subject to medical prescription as defined in title vi , other than radiopharmaceuticals and medicinal products sold directly by producers , without any intermediary , to clinical establishments in which the products are directly administered to the patient ; safety features may be applied , on the basis of a case - by - case analysis , to non - prescription medicinal products where the risk related to the product indicates , on the basis of the criteria set out in article 54a , that there are reasonable grounds for considering that the product may be falsified .


### however , detailed rules may be agreed with the commission in order to facilitate the implementation of the union delegations ' operating appropriations entered in the eeas and the council sections of the budget . ### however , detailed rules may be agreed with the commission in order to facilitate the implementation of the union delegations ' operating appropriations entered in the eeas section of the budget .


### ownership of sst sensors and adequate technical and human resources to operate them or data processing capacities ; ### ownership of sst sensors or data processing capacities and adequate technical and human resources to operate them ;


### the operation of sst services should be based on a partnership between the union and the member states and use existing as well as future national expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal . ### the operation of sst services should be based on a partnership between the union and the member states and use existing as well as future national and european expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states and esa . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal .


### the member states which comply with the criteria set out in paragraph 1 and which are parties to the agreement referred to in article 10 shall be eligible for financial contribution from the sst support programme . the commission shall publish and update on its website the list of member states . ### the member states which comply with the criteria set out in paragraph 1 and which are parties to the agreement referred to in article 10 shall be eligible for financial contribution from the sst support programme . the commission shall publish and update on its website the list of participating member states .


### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . union funding for the sst support programme should be drawn from relevant programmes provided for in the multiannual financial framework for 2014 - 2020 . ______________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 . ### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . the amount of union funding for the sst support programme should be eur 70 million in current prices . it should primarily be drawn from the programmes dedicated to space policy in the multiannual financial framework for 2014 - 2020 , i . e . egnos / galileo and copernicus , preferably through specific budget lines under these programmes , while ensuring that their own objectives are not jeopardised . in certain cases , contributions from the internal security fund and the horizon 2020 programme should also be possible but should be strictly limited to actions provided for in their basic acts , related to the protection of critical infrastructure and to space and security research respectively . any increase in the union contribution should be sought for among galileo and copernicus programmes . ________________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 .


### the european union satellite centre shall participate in the implementation of the objective set out in point of article 3 and shall be eligible for financial contribution from the sst support programme subject to the conclusion of the agreement referred to in article 10 . ### the european union satellite centre shall participate in the implementation of the main actions set out in article 3 and shall be eligible for financial contribution from the sst support programme subject to the conclusion of the agreement referred to in article 10 .


### the use and exchange of sst data and information for the purposes of the implementation of the objectives referred to in article 3 shall be subject to the following rules : ### the use and exchange of sst data and information for the purposes of the implementation of the main actions referred to in article 3 shall be subject to the following rules :


### the operation of sst services should be based on a partnership between the union and the member states and use existing as well as future national expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal . ### the operation of sst services should be based on a partnership between the union , the member states and the esa and use existing as well as future national and european expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states and esa . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal .


### union funding for the sst support programme shall be drawn from other programmes provided for in the multiannual financial framework for 2014 - 2020 in full compatibility with their legal base . the relevant programmes from which funding could be drawn include the programmes established by the following acts : regulation no [ &#8230 ; ] of the european parliament and the council on the implementation and exploitation of european satellite navigation systems articles 1 , 3 and and 4 ; council decision no [ … ] establishing the specific programme implementing horizon 2020 , article 2 and , annex part ii , point 1 . 6 . 2 and annex part iii , point 6 . 3 . 4 ; regulation no [ … ] of the european parliament and the council establishing , as part of the internal security fund , the instrument for financial support for police cooperation , preventing and combating crime , and crisis management , article 3 and . ### the union contribution to the sst support programme shall be eur 70 million for 2014 - 2020 in current prices , to be drawn primarily and in equivalent proportions from the programmes established by the following acts : regulation no [ &#8230 ; ] of the european parliament and the council on the implementation and exploitation of european satellite navigation systems , articles 1 , 3 and and 4 ; regulation no [ … ] of the european parliament and the council establishing the copernicus programme , article 5 . part of the contribution may also , to a limited extent and in accordance with their basic acts , be drawn from the programmes established by regulation no [ … ] of the european parliament and the council establishing , as part of the internal security fund , the instrument for financial support for police cooperation , preventing and combating crime , and crisis management , article 3 and and by council decision no [ … ] establishing the specific programme implementing horizon 2020 , article 2 and , annex part ii , point 1 . 6 . 2 and annex part iii , point 6 . 3 . 4 .


### the setting up and operation of a service function to provide sst services to spacecraft operators and public authorities . ### the setting up and operation of a service function to provide the sst services defined in article 4 to the entities referred to in article 4 .


### member states wishing to participate in the implementation of the objectives set out in article 3 shall submit an application to the commission demonstrating compliance with the following criteria : ### member states wishing to participate in the implementation of the objectives set out in article 3 shall submit an application to the commission directly , or via a national or multinational consortium or public entity , which demonstrates compliance with the following criteria :


### unauthorised disclosure of data and information shall be prevented while allowing efficient operations and maximising the use of the generated information ; ### unauthorised disclosure of sst data and information shall be prevented while allowing efficient operations and maximising the use of the generated sst information ;


### the provision of sst services will benefit all public and private operators of space - based infrastructures , including the union in view of its responsibilities for its eu space programmes – european geostationary navigation overlay service and galileo being implemented by regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 12 and copernicus / gmes established by regulation no 911 / 2010 of the european parliament and of the council of 22 september 2010 on the european earth monitoring programme and its initial operations 13 . re - entry warnings will also benefit national public authorities concerned with civil protection . __________________ 12 oj l 196 , 27 . 4 . 2008 , p . 1 . 13 oj l 276 , 20 . 10 . 2010 , p . 1 . ### the provision of sst services will benefit all public and private operators of space - based infrastructures , including the union in view of its responsibilities for its eu space programmes – european geostationary navigation overlay service and galileo being implemented by regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 12 and copernicus / gmes established by regulation no 911 / 2010 of the european parliament and of the council of 22 september 2010 on the european earth monitoring programme and its initial operations 13 . warnings about uncontrolled re - entry and estimated earthfall zones and times will also benefit national public authorities concerned with civil protection . __________________ 12 oj l 196 , 27 . 4 . 2008 , p . 1 . 13 oj l 276 , 20 . 10 . 2010 , p . 1 .


### manage the funds to be drawn to the sst support programme and ensure the implementation of the sst support programme ; ### manage the funds to be drawn to the sst support programme and ensure the implementation of the sst support programme while providing transparency and clarity regarding the different sources of funding ;


### the establishment and operation of a sensor function consisting of a network of ground - based or space - based existing national sensors to survey and track space objects ; ### the establishment and operation of a sensor function consisting of a network of ground - based or space - based existing national sensors , and expansion of that network by upgrading existing sensors or installing new sensors where necessary , in order to survey and track space objects completely independently ;


### the establishment and operation of a sensor function consisting of a network of ground - based or space - based existing national sensors to survey and track space objects ; ### the establishment and operation of a sensor function consisting of a network of ground - based or space - based national sensors to survey and track space objects and to produce a related database ;


### the member states which comply with the criteria set out in paragraph 1 and which are parties to the agreement referred to in article 10 shall be eligible for financial contribution from the sst support programme . the commission shall publish and update on its website the list of member states . ### the member states which comply with the criteria set out in paragraph 1 and which are parties to the agreement referred to in article 10 shall be eligible for financial contribution from the sst support programme . the commission shall publish and update on its website the list of member states and their respective financial contributions .


### ownership of sst sensors and adequate technical and human resources to operate them or data processing capacities ; ### a capacity to provide to the sst system any of the following : - sst sensors and adequate technical and human resources to operate them , or - analysis and data processing capacities specifically designed for sst ;


### the objectives of the sst support programme shall be to support actions aimed at establishing a sst capability and , in particular : ### the objectives of the sst support programme shall be to support actions aimed at establishing and maintaining a sst capability and , in particular :


### the member states which comply with the criteria set out in article 7 and the eusc shall conclude an agreement laying down the rules and mechanisms for their cooperation in the implementation of the objectives set out in article 3 . in particular , that agreement shall include provisions on the following : ### the participating member states and the eusc shall conclude an agreement laying down the rules and mechanisms for their cooperation in the implementation of the objectives set out in article 3 . in particular , that agreement shall include provisions on the following :


### the operation of sst services should be based on a partnership between the union and the member states and use existing as well as future national expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal . ### the operation of sst services should be based on a partnership between the union and the member states and use existing as well as future national and european expertise and assets , such as mathematical analysis and modelling know - how , ground - based radars or telescopes made available by participating member states and esa . the member states retain ownership and control over their assets and remain responsible for their operations , maintenance and renewal .


### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . union funding for the sst support programme should be drawn from relevant programmes provided for in the multiannual financial framework for 2014 - 2020 . __________________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 . ### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . the amount of union funding for the sst support programme should be set at eur 70 million in current prices and should be drawn from relevant programmes provided for in the multiannual financial framework for 2014 - 2020 , particularly the instrument for financial support for police cooperation , preventing and combating crime , and crisis management , under the internal security fund established by regulation no . . . / 2013 of the european parliament and the council18a , the galileo and egnos programmes established by regulation no . . . / 2013 of the european parliament and the council18b and the copernicus programme established by regulation no . . . / 2014 of the european parliament and the council18c . __________________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 . 18a regulation no . . . / 2013 of the european parliament and of the council of . . . 2013 establishing , as part of the internal security fund , the instrument for financial support for police cooperation , preventing and combating crime , and crisis management . 18b regulation no . . . / 2013 of the european parliament and of the council of . . . 2013 on the implementation and exploitation of european satellite navigation systems and repealing council regulation no 876 / 2002 and regulation no 683 / 2008 of the european parliament and of the council . 18c regulation no . . . / 2013 of the european parliament and of the council of . . . 2013 establishing the copernicus programme and repealing regulation no 911 / 2010 .


### space debris has become the most serious threat to the sustainability of space activities . a space surveillance and tracking support programme should therefore be established with the aim to support the setting up and operation of services consisting of monitoring and surveying space objects with a view to preventing damage to spacecraft resulting from collisions , as well as to prevent damage to ground infrastructure or human population as a result of uncontrolled re - entries of entire spacecraft or space debris thereof into the earth ' s atmosphere . ### space debris has become a serious threat to the sustainability of space activities . a space surveillance and tracking support programme should therefore be established with the aim to support the setting up and operation of services consisting of monitoring and surveying space objects with a view to preventing damage to spacecraft resulting from collisions , as well as to prevent damage to ground infrastructure or human population as a result of uncontrolled re - entries of entire spacecraft or space debris thereof into the earth ' s atmosphere .


### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . union funding for the sst support programme should be drawn from relevant programmes provided for in the multiannual financial framework for 2014 - 2020 . ______________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 . ### the sst support programme should be financed by the union in accordance with regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union18 . the amount of union funding for the sst support programme should be eur 70 million in current prices . it should primarily be drawn from the programmes dedicated to space policy in the multiannual financial framework for 2014 - 2020 , i . e . egnos / galileo and copernicus , preferably through specific budget lines under these programmes , while ensuring that their own objectives are not jeopardised . in certain cases , contributions from the internal security fund and the horizon 2020 programme should also be possible but should be strictly limited to actions provided for in their basic acts , related to the protection of critical infrastructure and to space and security research respectively . any increase in the union contribution should be sought for among galileo and copernicus programmes . ________________ 18 oj l 298 , 26 . 10 . 2012 , p . 1 .


### the european union satellite centre shall participate in the implementation of the objective set out in point of article 3 and shall be eligible for financial contribution from the sst support programme subject to the conclusion of the agreement referred to in article 10 . ### the european union satellite centre shall participate in the implementation of the main actions set out in article 3 and shall be eligible for financial contribution from the sst support programme subject to the conclusion of the agreement referred to in article 10 .


### the commission may on its own initiative until four weeks after it has been informed of the closure of the negotiations at the latest or on request from the member state which has negotiated the intergovernmental agreement , assess the compatibility of the negotiated agreement with union law before the agreement has been signed . in case the commission or the member state concerned ask for such an ex - ante assessment of the negotiated intergovernmental agreement with union law , the negotiated but not yet signed draft intergovernmental agreement shall be submitted to the commission for examination . the member state concerned shall refrain from signing the agreement for a period of four months following the submission of the draft intergovernmental agreement . in agreement with the member state concerned , the examination period might be prolonged . when a compatibility control has been requested , in the absence of an opinion by the commission within the examination period , the commission shall be deemed not to have raised objections . ### as early as possible and no later than four weeks after closure of the negotiations , the member state concerned shall inform the commission of the closure of the negotiations and shall submit the negotiated but not yet signed draft intergovernmental agreement , including its&#160 ; annexes and other texts it refers to explicitly , &#160 ; to the commission for examination . the commission shall inform that member state , within two months of being informed of the closure of the negotiations , of any doubts about the compatibility of the negotiated agreement , and its annexes and other texts it refers to explicitly , with union law , in particular with union competition law and internal energy market legislation , or with international agreements concluded by the union . the member state concerned shall refrain from signing the agreement for a period of two months following the submission of the intergovernmental agreement . in the absence of a response from the commission within that period , the commission shall be deemed not to have raised objections . the member state shall postpone the signing of an intergovernmental agreement for another two months if it has received a response from the commission that the negotiated but not yet signed agreement is not compatible with union law or international agreements concluded by the union . within those two months the commission shall issue a legal opinion . 2 . where the legal opinion identifies incompatibility between the negotiated agreement and union law or international agreements concluded by the union , the commission shall specify that incompatibility and shall make recommendations on how to eliminate the incompatibility . 3 . member states shall take due account of the commission ' s recommendations and , if necessary , renegotiate the agreement . if the recommendations are not taken into account and serious doubts persist about the compatibility of the signed intergovernmental agreement with union law or international agreements concluded by the union , the commission shall consider corrective measures to rectify the situation .


### when providing information to the commission in accordance with article 3 , the member state may indicate whether any part of the information , in particular commercial information , is to be regarded as confidential and whether the information provided can be shared with other member states . the commission shall respect these indications . requests for confidentiality do not restrict access of the commission itself to confidential information . ### when providing information to the commission in accordance with article 3 , the member state shall choose the form in which the information is to be forwarded to ensure that sensitive commercial information is protected .


### upon ratification of an intergovernmental agreement or of an amendment to an intergovernmental agreement , the member state concerned shall submit the agreement or the amendment of the agreement , including their annexes and other texts these agreements or amendments refer to explicitly , to the commission which shall make the received documents , with the exception of confidential parts identified according to article 7 , accessible to all other member states in electronic form . ### upon ratification of an intergovernmental agreement or of an amendment to an intergovernmental agreement , the member state concerned shall submit to the commission the agreement or the amendment to the agreement , including its annexes . furthermore , where these agreements refer explicitly to other texts , member states shall submit those other texts insofar as they contain elements which impact on the functioning of the internal market for energy or on the security of energy supply in the union . however , agreements between commercial entities are not subject to this obligation .


### upon ratification of an intergovernmental agreement or of an amendment to an intergovernmental agreement , the member state concerned shall submit the agreement or the amendment of the agreement , including their annexes and other texts these agreements or amendments refer to explicitly , to the commission which shall make the received documents , with the exception of confidential parts identified according to article 7 , accessible to all other member states in electronic form . ### upon ratification of an intergovernmental agreement or of an amendment to an intergovernmental agreement , the member state concerned shall submit to the commission the agreement or the amendment of the agreement , including their annexes and other texts these agreements or amendments refer to explicitly insofar as these other texts contain elements which have an operational impact on the functioning of the internal energy market or the security of energy supply . member states may make available summaries of the information submitted . according to the instructions of the member state concerned , the commission shall make the received documents , with the exception of confidential parts identified according to article 7 , accessible to all other member states in electronic form .


### when a member state intends to enter into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of its intention at the earliest possible moment before the envisaged opening of the negotiations . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the commission shall make the received information accessible to all member states in electronic form . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations . ### when a member state enters into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of the objectives of the negotiations , the provisions to be addressed in the negotiations , and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations .


### the commission may on its own initiative until four weeks after it has been informed of the closure of the negotiations at the latest or on request from the member state which has negotiated the intergovernmental agreement , assess the compatibility of the negotiated agreement with union law before the agreement has been signed . in case the commission or the member state concerned ask for such an ex - ante assessment of the negotiated intergovernmental agreement with union law , the negotiated but not yet signed draft intergovernmental agreement shall be submitted to the commission for examination . the member state concerned shall refrain from signing the agreement for a period of four months following the submission of the draft intergovernmental agreement . in agreement with the member state concerned , the examination period might be prolonged . when a compatibility control has been requested , in the absence of an opinion by the commission within the examination period , the commission shall be deemed not to have raised objections . ### as early as possible and not later than two weeks after closure of the negotiations the member state concerned shall inform the commission of the closure of the negotiations and shall submit the negotiated but not yet signed draft intergovernmental agreement , including its&#160 ; annexes and other texts it refers to explicitly , &#160 ; to the commission for examination . the commission shall , on its own initiative or at the request of the member state that negotiated the intergovernmental agreement , inform that member state , within two months after being informed of the closure of the negotiations , of any doubts on the compatibility of the negotiated agreement , and its annexes and other texts it refers to explicitly , with union law , in particular with eu competition law and eu internal energy market legislation . the member state concerned shall refrain from signing the agreement for a period of two months following the submission of the intergovernmental agreement . in the absence of a response from the commission within that period , the commission shall be deemed not to have raised objections . the member state shall postpone the signing of an intergovernmental agreement for another two months if it has received a response from the commission that the negotiated but not yet signed agreement , is not compatible with union law . within those two months the commission shall issue a legal opinion . 2 . where the legal opinion identifies incompatibility between the negotiated agreement and union law , the commission shall specify that incompatibility and shall make recommendations on how to eliminate the incompatibility . 3 . member states shall take due account of the commission ' s recommendations and , if necessary , renegotiate the agreement . if the recommendations are not taken into account and serious doubts persist about the compatibility of the signed intergovernmental agreement with union law , the commission shall consider launching infringement proceedings .


### member states shall submit all existing and provisionally applied intergovernmental agreements between them and third countries in their entirety , including their annexes and other texts they refer to explicitly and all amendments thereto to the commission at the latest three months after the entry into force of this decision . the commission shall make the received documents accessible in electronic form to all other member states . existing or provisionally applied intergovernmental agreements which have already been communicated in accordance with regulation no 994 / 2010 to the commission at the date of entry into force of this decision , which are fulfilling the requirements of this paragraph , shall be considered as communicated for the purposes of this decision . ### member states shall submit to the commission at the latest three months after the entry into force of this decision all intergovernmental agreements between them and third countries , including their annexes and all amendments thereto , as well as other texts they refer to explicitly insofar as these other texts contain elements which have an operational impact on the functioning of the internal energy market or the security of energy supply . the commission shall make the received documents , except confidential parts , accessible in electronic form to all other member states . within 12 months after the reception of the respective intergovernmental agreements , the commission , in cooperation with the eeas regarding the union ' s external policies , shall evaluate the agreements communicated and inform the concerned member states about the possible incompatibility of their agreements with union law and with international agreements concluded by the union . existing or provisionally applied intergovernmental agreements which have already been communicated in accordance with regulation no 994 / 2010 to the commission at the date of entry into force of this decision , which are fulfilling the requirements of this paragraph , shall be considered as communicated for the purposes of this decision .


### member states shall submit all existing and provisionally applied intergovernmental agreements between them and third countries in their entirety , including their annexes and other texts they refer to explicitly and all amendments thereto to the commission at the latest three months after the entry into force of this decision . the commission shall make the received documents accessible in electronic form to all other member states . existing or provisionally applied intergovernmental agreements which have already been communicated in accordance with regulation no 994 / 2010 to the commission at the date of entry into force of this decision , which are fulfilling the requirements of this paragraph , shall be considered as communicated for the purposes of this decision . ### member states shall submit all existing and provisionally applied intergovernmental agreements between them and third countries in their entirety , including their annexes and other texts they refer to explicitly and all amendments thereto to the commission at the latest three months after the entry into force of this decision . within six months of the submission of the intergovernmental agreements in their entirety , the commission shall assess their compatibility with eu law , especially with eu competition law and legislation concerning the internal energy market . should the commission consider that an intergovernmental agreement is not compatible with eu law , the member state concerned shall take all necessary steps to eliminate the incompatibility identified . the commission shall make the received documents accessible in electronic form to all other member states , but shall not disclose information identified as confidential by the member state concerned .


### member states shall submit all existing and provisionally applied intergovernmental agreements between them and third countries in their entirety , including their annexes and other texts they refer to explicitly and all amendments thereto to the commission at the latest three months after the entry into force of this decision . the commission shall make the received documents accessible in electronic form to all other member states . existing or provisionally applied intergovernmental agreements which have already been communicated in accordance with regulation no 994 / 2010 to the commission at the date of entry into force of this decision , which are fulfilling the requirements of this paragraph , shall be considered as communicated for the purposes of this decision . ### member states shall submit all existing and provisionally applied intergovernmental agreements between them and third countries in their entirety , including their annexes and other non - commercial texts they refer to explicitly and all amendments thereto to the commission at the latest three months after the entry into force of this decision . the commission shall make the received documents accessible to all other member states in a suitable form ensuring that sensitive information is protected . existing or provisionally applied intergovernmental agreements which have already been communicated in accordance with regulation no 994 / 2010 to the commission at the date of entry into force of this decision , which are fulfilling the requirements of this paragraph , shall be considered as communicated for the purposes of this decision .


### member states should already notify the intention to open negotiations to the commission with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements . the commission should be kept informed regularly on the ongoing negotiations . it should have the right to participate as an observer in the negotiations . member states may also request the commission to assist them during their negotiations with third countries . ### member states should notify the commission when negotiations on a new intergovernmental agreement or amendments to existing intergovernmental agreements have been started . the commission should be kept informed regularly on the ongoing negotiations . at the request of the commission or the member state concerned , the commission may participate as an observer in the negotiations . member states may also request the commission to assist them during their negotiations with third countries , without jeopardising their ability to negotiate the content of the agreements .


### review four years after its entry into force , the commission shall submit a report on the application of this decision to the european parliament , the council and the european economic and social committee . 2 . the report shall in particular assess whether this decision provides for a sufficient framework in order to ensure full compliance of intergovernmental agreements with union law and a high level of coordination between member states with regard to intergovernmental agreements . ### reporting and review the commission shall submit a report on the application of this decision to the european parliament , the council and the european economic and social committee annually . the report shall cover the information received pursuant to article 3 . 2 . the commission should also provide the european parliament with a comprehensive evaluation report within four years of the entering into force of this decision . the evaluation report shall in particular assess whether this decision provides for a sufficient framework in order to ensure full compliance of intergovernmental agreements with union law and a high level of coordination between member states with regard to intergovernmental agreements .


### identify common problems in relation to intergovernmental agreements and to consider appropriate action to address these problems ; ### identify common problems in relation to intergovernmental agreements and to propose solutions for these problems ;


### this decision establishes a mechanism for the exchange of information between member states and the commission with regard to intergovernmental agreements . ### this decision establishes a mechanism for the exchange of information between member states and the commission with regard to intergovernmental agreements in the field of energy as defined in article 2 .


### union - law requires member states to take all appropriate measures to ensure fulfilment of the obligations arising out of the treaties or resulting from the acts of the institutions of the union . member states should therefore avoid or eliminate any incompatibilities between union law and international agreements concluded between member states and third countries . ### union law requires member states to take all appropriate measures to ensure fulfilment of the obligations arising out of the treaties , and in particular article 194 of the treaty on the functioning of the european union , and resulting from the acts of the institutions of the . member states should therefore avoid or eliminate any incompatibilities between union law and international agreements concluded between and third countries .


### ' intergovernmental agreements ' means any legally binding agreements between member states and third countries which are likely to have an impact on the operation or the functioning of the internal market for energy or on the security of energy supply in the union ; ### ' intergovernmental agreements ' means any legally binding agreements between member states and third countries which have an impact on the operation or the functioning of the internal market for energy or on the security of energy supply in the union ;


### on the basis of best practice , develop standard clauses the use of which would ensure full compliance of future intergovernmental agreements with union energy legislation . ### on the basis of best practice and in consultation with the member states , develop non - binding standard clauses the use of which would ensure full compliance of future intergovernmental agreements with union energy legislation .


### on the basis of best practice , develop standard clauses the use of which would ensure full compliance of future intergovernmental agreements with union energy legislation . ### develop non - binding standard clauses on the basis of best practices , the use of which would significantly improve compliance of future intergovernmental agreements with union energy legislation .


### when a member state intends to enter into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of its intention at the earliest possible moment before the envisaged opening of the negotiations . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the commission shall make the received information accessible to all member states in electronic form . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations . ### when a member state intends to enter into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of its intention at the earliest possible moment and at the latest 3 months before the envisaged opening of the negotiations . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . if requested by the commission or by the member state concerned , the commission shall participate as an observer in the negotiations and provide legal advice to the negotiating member state on how to avoid incompatibility between the negotiated intergovernmental agreement and union law .


### the new information exchange mechanism should only cover intergovernmental agreements which are likley to have an impact on the internal market for energy or on the security of energy supply as these two issues are intrinsically linked . it should comprise in particular all intergovernmental agreements which have an impact on the supply of gas , oil or electricity through fixed infrastructure or which have an impact on the amount of energy imported into the union from third countries . ### the new information exchange mechanism should only cover intergovernmental agreements which have an impact on the internal market for energy or on the security of energy supply as these two issues are intrinsically linked . it should comprise in particular all intergovernmental agreements which have an impact on the supply of gas , oil or electricity through fixed infrastructure or which have an impact on the amount of energy imported into the union from third countries .


### a permanent exchange of information on intergovernmental agreements at union level should allow to develop best practices . on the basis of those best practices the commission should recommend standard clauses for the use in intergovernmental agreements between member states and third countries . the use of these non - binding standard clauses should exclude conflicts of intergovernmental agreements with union law . ### a permanent exchange of information on intergovernmental agreements at union level should allow to develop best practices . on the basis of those best practices the commission should recommend non - binding standard clauses for the use in intergovernmental agreements between member states and third countries . the use of these non - binding standard clauses should exclude conflicts of intergovernmental agreements with union law .


### the new information exchange mechanism should only cover intergovernmental agreements which are likley to have an impact on the internal market for energy or on the security of energy supply as these two issues are intrinsically linked . it should comprise in particular all intergovernmental agreements which have an impact on the supply of gas , oil or electricity through fixed infrastructure or which have an impact on the amount of energy imported into the union from third countries . ### the new information exchange mechanism should cover all intergovernmental agreements which have an impact on the supply of gas , oil or electricity through fixed infrastructure or which have an impact on the amount of energy imported into the union from third countries . for the purpose of this decision , agreements between member states and publicly owned commercial entities in third countries should also be considered ' intergovernmental agreements ' .


### the proper functioning of the internal energy market requires that the energy imported into the union from third countries , is fully governed by the rules establishing an internal energy market . an internal energy market that is not functioning properly puts the eu in a vulnerable position with regard to security of energy supply . a high degree of transparency with regard to agreements between member states and third countries in the field of energy would allow the union to take coordinated action , in a spirit of solidarity , in order to ensure that such agreements are in accordance with union legislation and effectively secure the supply of energy . ### the proper functioning of the internal energy market and the safeguarding of consumer protection requires that the energy imported into the union from third countries , is fully governed by the rules establishing an internal energy market . an internal energy market that is not functioning properly puts the eu in a vulnerable position with regard to security of energy supply , while at the same time diminishing its political leverage at international level . a high degree of transparency with regard to agreements between member states and third countries in the field of energy would allow the union to take coordinated action , in a spirit of solidarity , in order to ensure that such agreements are in accordance with union legislation and effectively secure the supply of energy .


### when a member state intends to enter into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of its intention at the earliest possible moment before the envisaged opening of the negotiations . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the commission shall make the received information accessible to all member states in electronic form . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations . ### when a member state intends to enter into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of its intention at the earliest possible moment before the envisaged opening of the negotiations . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the member state concerned shall keep the commission informed regularly of the ongoing negotiations .


### when a member state intends to enter into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of its intention at the earliest possible moment before the envisaged opening of the negotiations . the information provided to the commission shall include the relevant documentation , an indication of the provisions to be addressed in the negotiations , the objectives of the negotiations and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the commission shall make the received information accessible to all member states in electronic form . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations . ### when a member state enters into negotiations with a third country in order to amend an existing intergovernmental agreement or to conclude a new intergovernmental agreement , the member state shall inform the commission in writing of the objectives of the negotiations , the provisions to be addressed in the negotiations , and other relevant information . in case of amendments to an existing agreement , the provisions that are to be renegotiated shall be indicated in the information provided to the commission . the member state concerned shall keep the commission informed regularly of the ongoing negotiations . on request of the commission or the member state concerned , the commission may participate as an observer in the negotiations .


### member states shall submit all existing and provisionally applied intergovernmental agreements between them and third countries in their entirety , including their annexes and other texts they refer to explicitly and all amendments thereto to the commission at the latest three months after the entry into force of this decision . the commission shall make the received documents accessible in electronic form to all other member states . existing or provisionally applied intergovernmental agreements which have already been communicated in accordance with regulation no 994 / 2010 to the commission at the date of entry into force of this decision , which are fulfilling the requirements of this paragraph , shall be considered as communicated for the purposes of this decision . ### member states shall submit all existing and provisionally applied intergovernmental agreements between them and third countries in their entirety , including their annexes and other texts they refer to explicitly and all amendments thereto to the commission at the latest three months after the entry into force of this decision . within 6 months following the submission of the intergovernmental agreements in their entirety , including their annexes and other texts they refer to explicitly and all amendments thereto , the commission shall assess their compatibility with union law , in particular with eu competition law and internal energy market legislation . where the submitted intergovernmental agreement is not compatible with union law , the member state shall take all appropriate steps to eliminate the incompatibility identified . the commission shall make the received documents accessible in electronic form to all other member states but shall not disclose information that is indicated as confidential by the respective member state .