### today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in directive 2001 / 83 / ec . in order to ensure reliability in the distribution chain , pharmaceutical legislation should address all actors in the distribution chain : this includes not only distributors who procure , hold , store and supply products , but also persons who are involved in transactions without handling the products . they should be submitted to proportionate rules in order to exclude , by all practical means , the possibility that medicinal products which are falsified in relation to their identity , history or source to enter the legal supply chain in the community . ### today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in directive 2001 / 83 / ec , such as traders and brokers . in order to ensure reliability in the distribution chain , pharmaceutical legislation should address all actors in the distribution chain : this includes not only distributors who procure , hold , store and supply products , but also persons who are involved in transactions without handling the products , such as traders and brokers . they should be clearly and unambiguously defined , as should their responsibilities , and should be submitted to proportionate rules in order to exclude , by all practical means , the possibility that medicinal products which are falsified in relation to their identity , history or source to enter the legal supply chain in the community . in particular , such persons must have a valid licence for their business activities , which must be conducted in accordance with the good practice laid down by the commission , in cooperation with the agency and the member state authorities , by analogy with that applying to producers and distributors of medicinal products .


### falsified active pharmaceutical ingredients pose the risk of sub - standard active pharmaceutical ingredients . this risk should be addressed . in particular , manufacturers of medicinal products should ensure either by themselves of through a body accredited for that purpose that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices . ### falsified active pharmaceutical ingredients pose the risk of sub - standard active pharmaceutical ingredients . this risk should be addressed by combining an effective inspection system with a system ensuring the traceability of active pharmaceutical ingredients . in particular , manufacturers of medicinal products should themselves ensure that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices .


### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . ### the manufacture of active pharmaceutical ingredients or excipients should be subject to the relevant good manufacturing practices in force within the community irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation .


### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . ### with a view to ensuring a high level of protection for public health the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that good manufacturing practice is complied with , by means of repeated mandatory inspections carried out by the competent community authorities or the authorities of countries with which mutual recognition agreements covering , inter alia , active pharmaceutical ingredients , are in force .


### all activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products , or billing or brokering medicinal products , apart from supplying medicinal products to the public , and not falling under the definition of wholesale distribution . ’ ### all activities consisting of the sale , purchase or billing of medicinal products , apart from the physical handling and supply of medicinal products to the public , and not falling under the definition of wholesale distribution . ’


### ' to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ’ ### ' to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall ensure that production operations are conducted in accordance with the guidelines and standards of good manufacturing practice in force within the community through the performance of mandatory inspections by the competent community authorities or the authorities of countries with which mutual recognition agreements covering , inter alia , active pharmaceutical ingredients , are in force . '


### ' to inform the competent authority of products he gets knowledge of which are or which are suspected to be falsified in relation to the identity , history or source of products manufactured by him . ' ### ' to inform the competent authority of products he gets knowledge of which are or which are reliably suspected to be falsified in relation to the identity , history or source of products manufactured by him . '


### 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 .


### notwithstanding article 2 , and without prejudice to title vii , member states shall ensure that medicinal products not intended to be placed on the market are not introduced into the community if there are reasons to believe that the products claim a falsified identity , history or source . ### notwithstanding article 2 , and without prejudice to title vii , member states shall ensure that medicinal products not intended to be placed on the market are not introduced into and do not transit through the community if there are reasons to believe that the products claim a falsified identity , history or source .


### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without opening the immediate packaging as defined in article 1 ; ### the manufacturing authorisation holder complies with point of article 54 by replacing the safety features with safety features which are qualitatively and quantitatively equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without opening the immediate packaging as defined in article 1 ;


### ‘ wholesale distribution and trading of medicinal products’ ; ### ‘ wholesale distribution , brokering and trading of medicinal products’ ;


### ' 4 . the member states shall forward to the agency a copy of the authorization referred to in paragraph 1 . the agency shall enter that information in the community database referred to in article 111 . at the request of the commission or any member state , member states shall supply all appropriate information concerning the individual authorization which they have granted under paragraph 1 . ' ### ' 4 . the member states shall forward to the agency a copy of the authorization referred to in paragraph 1 . the agency shall enter that information in the community database referred to in article 111 . at the request of the commission or any member state , member states shall supply , within a reasonable period of time , all appropriate information concerning the individual authorization which they have granted under paragraph 1 . '


### they must inform the competent authority of products they receive which they identify as infringing , or they suspect of infringing , either of the following : ### they must inform the competent authority of products they receive , trade or broker which they identify as infringing , or they suspect of infringing , either of the following :


### for the purpose of point , in the case where the product is obtained from another wholesale distributor , holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor either by themselves or through a body accredited for that purpose by the competent authority of a member state . ### for the purpose of point , in the case where the product is obtained from another wholesale distributor , holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor and check that the latter holds a wholesale distribution authorisation .


### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , or wholesale distributor complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , or to the wholesale distributor who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , or wholesale distributor concerned the opportunity to submit their comments . ### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice and good distribution , trading and brokering practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , the wholesale distributor who has undergone the inspection or the trading or brokering authorisation holder . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , wholesale distributor , trader or broker concerned the opportunity to submit their comments .


### within 90 days of an inspection as referred to in paragraph 1 , a certificate of good manufacturing practice or good distribution practice shall be issued to the manufacturer , importer , or wholesale distributor if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice or good distribution practice as provided for by community legislation . ### within 90 days of an inspection as referred to in paragraph 1 , a certificate of good manufacturing practice , good distribution practice , good trading practice or good brokering practice shall be issued to the manufacturer , importer , or wholesale distributor if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice or good distribution practice , good trading practice and good brokering practice as provided for by community legislation .


### member states shall enter the certificates of good manufacturing practice and good distribution practice which they issue in a community database managed by the agency on behalf of the community . ### member states shall enter the certificates of good manufacturing practice , good distribution practice , good trading practice and good brokering practice which they issue in a community database managed by the agency on behalf of the community .


### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by community legislation , the information shall be entered in the community database referred to in paragraph 6 . ' ### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by community legislation , the information shall be entered in the community database referred to in paragraph 6 and the manufacturing and distribution processes must cease forthwith . '


### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by community legislation , the information shall be entered in the community database referred to in paragraph 6 . ### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices or good trading practices or good brokering practices as provided for by community legislation , the information shall be entered in the community database referred to in paragraph 6 .


### the commission shall adopt detailed guidelines laying down the principles for inspections referred to in article 111 . ### the commission shall adopt detailed guidelines laying down the principles for inspections referred to in article 111 and , in particular , the community and / or national bodies responsible for carrying out inspections .


### the commission shall , following a request from a third country , list that country by way of a decision if its regulatory framework for active substances exported to the community and the respective control and enforcement ensure a protection of public health equivalent to that in the community . particular account shall be taken of : ### the commission shall , following a request from a third country and the satisfactory conclusion of the inspection by the body responsible on the basis of article 111a , list that country by way of a decision if its regulatory framework for active substances exported to the community and the respective control and enforcement ensure a protection of public health equivalent to that in the community . particular account shall be taken of :


### the commission , in cooperation with the agency and competent authorities of the member states , shall verify regularly whether the conditions set out in paragraph 1 are fulfilled . the first verification shall take place no later than 3 years after the country has been listed in accordance with paragraph 1 . ### the commission , in cooperation with the agency and competent authorities of the member states , shall verify regularly whether the conditions set out in paragraph 1 are fulfilled . the first verification shall be conducted with a view to confirming compliance with the criteria set out in paragraph 1 and shall be followed by regular verifications at intervals of no less than 3 years .


### the competent authorities shall issue the accreditation referred to in articles 46 and 80 if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or , in the case of wholesale distributors , good distribution practices . ### the competent authorities shall issue the accreditation referred to in articles 46 and 80 if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or , in the case of wholesale distributors , good distribution practices or , in the case of traders , good trading practices or , in the case of brokers , good brokering practices .


### the member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by [ insert concrete date 18 months after publication ] at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate , dissuasive and equivalent . the member states shall notify those provisions to the commission by [ insert concrete date 6 months after publication ] at the latest and shall notify it without delay of any subsequent amendment affecting them .


### 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 ] .


### council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities , lays down the budgetary principles and financial rules which should be respected in all legislative acts . it is necessary to amend certain provisions of the financial regulation in order to take account of the amendments introduced by the treaty of lisbon . ### council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities , lays down the budgetary principles and financial rules which should be respected in all legislative acts . it is necessary to amend certain provisions of the financial regulation in order to take account of the amendments introduced by the treaty of lisbon and of the establishment of the european external action service .


### the treaty of lisbon establishes a european external action service . according to the conclusions of the european council of 29 and 30 october 2009 , the eeas is a service of a sui generis nature and should be treated as an institution for the purposes of the financial regulation . ### the treaty of lisbon establishes a european external action service . according to the council decision 2010 / . . . / eu of . . . establishing the organisation and functioning of the european external action service , the eeas is a service of a sui generis nature and is to be treated as an institution for the purposes of the financial regulation .


### given that the eeas should be treated as an institution for the purposes of the financial regulation , the european parliament is to grant discharge to the eeas for the implementation of the appropriations voted in the eeas section of the budget . the european parliament should also continue to grant discharge to the commission for the implementation of commission ' s section of the budget , including operational appropriations implemented by heads of delegations who are sub - delegated authorising officers of the commission . ### given that the eeas should be treated as an institution for the purposes of the financial regulation , the european parliament is to grant discharge to the eeas for the implementation of the appropriations voted in the eeas section of the budget . in this context , the eeas shall fully respect the procedures provided for in article 319 of the treaty on the functioning of the european union and in articles 145 to 147 of the financial regulation . the european parliament should also continue to grant discharge to the commission for the implementation of commission ' s section of the budget , including operational appropriations implemented by heads of delegations who are sub - delegated authorising officers of the commission . given the complexity of this structure , high - standard provisions on traceability and budgetary and financial accountability need to be applied .


### the lisbon treaty foresees that commission delegations become part of the eeas as union delegations . in order to ensure their efficient management , all administrative and support expenditure of union delegations which finance common costs should be executed by a single support service . to that effect , the financial regulation should foresee the possibility for detailed rules , to 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 . ### the lisbon treaty foresees that commission delegations become part of the eeas as union delegations . in order to ensure their efficient management , all administrative and support expenditure of union delegations which finance common costs should be executed by a single support service . to that effect , the financial regulation should foresee the possibility for detailed rules , to 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 .


### 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 . the proliferation of space debris also has an impact on the incidence of hazardous uncontrolled re - entries of space objects . an sst service should therefore be set up so as to forecast trajectories and re - entry paths in order to provide governments and civil protection services with useful 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 .


### civil - military ssa user requirements were defined in the commission staff working paper ‘ european space situational awareness high - level civil - military user requirements’14 endorsed by the member states in the political and security committee of the council on 18 november 201115 . the provision of sst services should serve only civilian purposes . purely military requirements should not be addressed by this decision . __________________ 14 sec 1247 final , 12 . 10 . 2011 . 15 council document 15715 / 11 , 24 . 10 . 2011 . ### civil - military ssa user requirements were defined in the commission staff working paper ‘ european space situational awareness high - level civil - military user requirements’14 endorsed by the member states in the political and security committee of the council on 18 november 201115 . the provision of sst services should serve both civilian and military purposes . a thorough analysis should be conducted on how eu member states ' military capabilities will benefit from sst services as well as on sst services contribution to safeguard the implementation of the outer space treaty . __________________ 14 sec 1247 final , 12 . 10 . 2011 . 15 council document 15715 / 11 , 24 . 10 . 2011 .


### civil - military ssa user requirements were defined in the commission staff working paper ' european space situational awareness high - level civil - military user requirements ' 14 endorsed by the member states in the political and security committee of the council on 18 november 201115 . the provision of sst services should serve only civilian purposes . purely military requirements should not be addressed by this decision . __________________ 14 sec 1247 final , 12 . 10 . 2011 . 15 council document 15715 / 11 , 24 . 10 . 2011 . ### civil - military ssa user requirements were defined in the commission staff working paper ' european space situational awareness high - level civil - military user requirements ' 14 endorsed by the member states in the political and security committee of the council on 18 november 201115 . the provision of sst services should serve only civilian purposes . purely military requirements should not be addressed by this decision . protection of military or dual - use satellites shall constitute a civilian purpose . __________________ 14 sec 1247 final , 12 . 10 . 2011 . 15 council document 15715 / 11 , 24 . 10 . 2011 .


### 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 .


### the european union satellite centre , an agency of the union established by council joint action of 20 july 2001 on the establishment of a european union satellite centre 16 which provides geospatial imagery information services and products with various levels of classification to civil and military users , could be responsible for the operation and provision of sst services . its expertise in handling confidential information in a secure environment and its tight institutional links with the member states is an asset facilitating the provision of sst services . a pre - condition for the eusc participation in the sst support programme is the amendment of the council joint action which does currently not provide for eusc action in the field of sst . __________________ 16 oj l 200 , 25 . 7 . 2001 , p . 5 . ### the european union satellite centre , an agency of the union established by council joint action of 20 july 2001 on the establishment of a european union satellite centre 16 which provides geospatial imagery information services and products with various levels of classification to civil and military users , could be responsible for the operation and provision of sst services . its expertise in handling classified information in a secure environment and its tight institutional links with the member states is an asset facilitating the provision of sst services . a pre - condition for the eusc participation in the sst support programme is the amendment of the council joint action which does currently not provide for eusc action in the field of sst . __________________ 16 oj l 200 , 25 . 7 . 2001 , p . 5 .


### precise information on the nature , specifications and location of certain space objects may affect the security of the european union or its member states . adequate security considerations should therefore be taken into account in the establishment and operation of the network of sst sensors , the capacity to process and analyse sst data and the provision of sst services . it is therefore necessary to lay down general provisions on the use and secure exchange of sst data and information between the member states , the eusc and the recipients of sst services in this decision . furthermore , the european commission and the european external action service should define the coordination mechanisms needed to address matters related to the security of the sst support programme . ### precise information on the nature , specifications and location of certain space objects may affect the security of the european union or its member states . adequate security considerations should therefore be taken into account in the establishment and operation of the network of sst sensors , the capacity to process and analyse sst data and the provision of sst services . it is therefore necessary to lay down general provisions on the use and secure exchange of sst data and information between the member states , the eusc and the recipients of sst services in this decision . in this respect , the existing infrastructure and expertise should be employed to avoid duplication , and create savings and synergies . furthermore , the european commission and the european external action service should define the coordination mechanisms needed to address matters related to the security of the sst support programme .


### precise information on the nature , specifications and location of certain space objects may affect the security of the european union or its member states . adequate security considerations should therefore be taken into account in the establishment and operation of the network of sst sensors , the capacity to process and analyse sst data and the provision of sst services . it is therefore necessary to lay down general provisions on the use and secure exchange of sst data and information between the member states , the eusc and the recipients of sst services in this decision . furthermore , the european commission and the european external action service should define the coordination mechanisms needed to address matters related to the security of the sst support programme . ### precise information on the nature , specifications and location of certain space objects may affect the security of the european union , its member states or third countries . adequate security considerations should therefore be taken into account in the establishment and operation of the network of sst sensors , the capacity to process and analyse sst data and the provision of sst services . it is therefore necessary to lay down general provisions on the use and secure exchange of sst data and information between the member states , the eusc and the recipients of sst services in this decision . furthermore , the european commission and the european external action service should define the coordination mechanisms needed to address matters related to the security of the sst support programme .


### ' space object ' means any man - made or natural object in outer space . ### ' space object ' means any man - made object in outer space .


### ' sst data ' means physical parameters of space objects acquired by sst sensors . ### ' sst data ' means physical parameters of space objects acquired by sst sensors or space objects ' orbital parameters derived from observations by those sensors .


### 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 , operation and enhancement 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 processing function to process and analyse the sst data captured by the sensors , including the capacity to detect and identify space objects and to build and maintain a catalogue thereof ; ### the establishment , operation and enhancement of a processing function to process and analyse the sst data captured by the sensors , including the capacity to detect and identify space objects and to build and maintain a catalogue thereof ;


### the setting up and operation of a service function to provide sst services to spacecraft operators and public authorities . ### the setting up , operation and enhancement of a service function to provide sst services to spacecraft operators and public authorities .


### the establishment and operation of a processing function to process and analyse the sst data captured by the sensors , including the capacity to detect and identify space objects and to build and maintain a catalogue thereof ; ### the establishment and operation of a processing function to process and analyse the sst data in order to produce sst information ;


### 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 .


### the detection and risk assessment of on - orbit explosions or break - ups or collisions ; ### the detection and characterisation of on - orbit fragmentations or break - ups or collisions ;


### the risk assessment of and alerts related to the re - entry of space objects and space debris into the earth ' s atmosphere and the prediction of the time and location of impact . ### risk assessment relating to the uncontrolled re - entry of space objects and space debris into the earth ' s atmosphere , and prediction of earthfall zones and times .


### sst services shall be provided to member states , the council , the commission , the eeas , public and private spacecraft operators , and public authorities concerned with civil protection . the sst services shall be provided in compliance with the provisions on the use and exchange of sst data and information set out in article 9 . ### sst services shall be provided to member states , the council , the commission , the eeas , esa , public and private spacecraft operators , and public authorities concerned with civil protection and security . they may also be provided to states which do not belong to the union , provided that parliament consents to an agreement to this effect . the sst services shall be available also to military satellite operators . the sst services shall be provided in compliance with the provisions on the use and exchange of sst data and information set out in article 9 .


### 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 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 . ### subject to a change of its basic act , 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 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 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 eusc shall be tasked with interfacing with end users . it shall establish and set up facilities for the retrieval of sst data and distribution of services to the entities specified in article 4 .


### 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 objective set out in point of article 3 and shall be eligible for financial contribution up to a ceiling from the sst support programme subject to the conclusion of the agreement referred to in article 10 .


### 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 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 :


### 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 .


### monitoring and evaluation ### monitoring , reporting and evaluation


### by 1 july 2018 , the commission shall submit an evaluation report on the implementation of the sst support programme to the european parliament and the council . that report shall include recommendations on the renewal , modification or suspension of the actions supported by the sst support programme taking into account the following : ### each year the commission shall submit an evaluation report on the implementation of the sst support programme to the european parliament and the council . that report shall include recommendations on the renewal , modification or suspension of the actions supported by the sst support programme taking into account the following :


### effectiveness of the use of resources . ### effectiveness of the use of resources , in particular taking into account the provision of funds for the eusc .


### the european council has asked member states to inform from 1 january 2012 the commission on all their new and existing bilateral energy agreements with third countries . the commission should make this information available to all other member states in an appropriate form , having regard to the need for protection of commercially sensitive information . ### the european council has asked member states to inform from 1 january 2012 the commission on all their new and existing bilateral energy agreements with third countries . the commission should make this information available to all other member states in an appropriate form , having regard to the need for protection of commercially sensitive information , as well as the preservation of union ' s strategic interests .


### 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 .


### 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 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 and disadvantageous 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 .


### 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 .


### the commission should make all received information available to all other member states in electronic form . the commission should respect requests from member states to treat information , in particular commercial information , submitted as confidential . requests for confidentiality should however not restrict access of the commission itself to confidential information as the commission needs to have comprehensive information for its own assessment . the requests for confidentiality are without prejudice to the right of access to documents as provided for in regulation no 1049 / 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament , council and commission documents . ### the commission should make all received non - confidential information available to all other member states in electronic form . the commission should respect requests from member states to treat information , in particular commercial information , submitted as confidential . requests for confidentiality should however not restrict access of the commission itself to confidential information as the commission needs to have comprehensive information for its own assessment . the commission is responsible for guaranteeing the application of the confidentiality clause and its legal consequences . the requests for confidentiality are without prejudice to the right of access to documents as provided for in regulation no 1049 / 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament , council and commission documents .


### the commission should make all received information available to all other member states in electronic form . the commission should respect requests from member states to treat information , in particular commercial information , submitted as confidential . requests for confidentiality should however not restrict access of the commission itself to confidential information as the commission needs to have comprehensive information for its own assessment . the requests for confidentiality are without prejudice to the right of access to documents as provided for in regulation no 1049 / 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament , council and commission documents . 16 ### the commission should make all received information available to all other member states in secure electronic form . the commission should respect requests from member states to treat information , in particular commercial information , submitted as confidential . requests for confidentiality should however not restrict access of the commission itself to confidential information as the commission needs to have comprehensive information for its own assessment . the requests for confidentiality are without prejudice to the right of access to documents as provided for in regulation no 1049 / 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament , council and commission documents . 16


### 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 , in cooperation with the eeas as regards union ' s external policies , 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 or with international agreements concluded by the union . the commission should also suggest non - binding standard clauses in reference to union ' s principles and policies such as the respect of human rights , democracy , good governance , the rule of law and social dialogues including corporate social responsibility , climate change , the protection of the environment , energy efficiency , renewable energies , and eu biofuel targets .


### 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 . in particular , standard clauses should address compliance of the intergovernmental agreement with union competition law and internal energy market rules . the use of these non - binding standard clauses should exclude conflicts of intergovernmental agreements with union law .


### the improved mutual knowledge of existing and new intergovernmental agreements should allow for a better co - ordination in energy matters between the member states themselves and between the member states and the commission . such improved coordination should enable member states to fully benefit from the political and economic weight of the union . ### the improved mutual knowledge of existing and new intergovernmental agreements should allow for a better co - ordination in energy matters between the member states themselves and between the member states and the commission . such improved coordination should enable member states to fully benefit from the political and economic weight of the union , allow the commission and member states to fully coordinate their efforts with respect to importing energy into the eu , including renewable energy , and strengthen the union ' s own strategic role and foreign policy capabilities .


### the improved mutual knowledge of existing and new intergovernmental agreements should allow for a better co - ordination in energy matters between the member states themselves and between the member states and the commission . such improved co - ordination should enable member states to fully benefit from the political and economic weight of the union . ### the improved mutual knowledge of existing and new intergovernmental agreements should allow for a better co - ordination in energy matters between the member states themselves and between the member states and the commission . such improved co - ordination should enable member states to fully benefit from the political and economic weight of the union and allow the commission to propose solutions for problems identified in the intergovernmental agreement .


### ' 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 in the field of energy . for the purpose of this decision , agreements between member states and publicly owned commercial entities in third countries shall also be considered ' intergovernmental agreements ' ;


### ' 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 or memoranda of understanding 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 ;


### 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 the agreement or the amendment of the agreement , including their annexes and other non - commercial 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 .


### review developments in relation to intergovernmental agreements ; ### review developments in relation to intergovernmental agreements and ensure consistency and coherence in the union ' s external energy relations with key producer , transit , and consumer countries ;


### 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 , to consider appropriate action to address these problems , and to propose possible solutions for the member states ;


### 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 .


### 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 .


### 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 . ### the report shall in particular assess whether this decision provides for a sufficient and effective 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 . if this decision does not ensure the full compatibility of intergovernmental agreements with union law and a high level of coordination between member states with regard to intergovernmental agreements , the commission shall , not later than a year after submission of the report , present , if appropriate , a review or complementary legislative proposal .


### where exceptional circumstances require immediate action in the situations referred to in articles 24 , 24a and 26 of the agreement or in the case of export aids that have a direct and immediate effect on trade , the precautionary measures provided for in article 27 of the agreement may be adopted by the commission in accordance with the procedure referred to in article 7 . in cases of urgency , article 7 shall apply . ### where exceptional circumstances require immediate action in the situations referred to in articles 24 , 24a and 26 of the agreement or in the case of export aids that have a direct and immediate effect on trade , the precautionary measures provided for in article 27 of the agreement may be adopted by the commission in accordance with the advisory procedure referred to in article 7 . in cases of urgency , article 7 shall apply .


### where exceptional circumstances require immediate action in the situations referred to in articles 25 , 25a and 27 of the agreement or in the case of export aids that have a direct and immediate effect on trade , the precautionary measures provided for in article 28 of the agreement may be adopted by the commission in accordance with the procedure referred to in article 7 . in cases of urgency , article 7 shall apply . ### where exceptional circumstances require immediate action in the situations referred to in articles 25 , 25a and 27 of the agreement or in the case of export aids that have a direct and immediate effect on trade , the precautionary measures provided for in article 28 of the agreement may be adopted by the commission in accordance with the advisory procedure referred to in article 7 . in cases of urgency , article 7 shall apply .


### where reference is made to this paragraph , article [ 8 ] of regulation no [ xxxx / 2011 ] shall apply in conjunction with article [ 5 ] thereof . ### where reference is made to this paragraph , article 8 of regulation no 182 / 2011 shall apply in conjunction with article 4 thereof .


### where reference is made to this paragraph , article [ 8 ] of regulation no [ xxxx / 2011 ] shall apply in conjunction with article [ 5 ] thereof . ### 3 where reference is made to this paragraph , article 8 of regulation no 182 / 2011 shall apply in conjunction with article 4 thereof .


### when it is found as a result of the examination procedure that the interests of the union do not require any action to be taken , the procedure shall be terminated by the commission acting in accordance with the procedure referred to in article 7 . ### when it is found as a result of the examination procedure that the interests of the union do not require any action to be taken , the procedure shall be terminated by the commission acting in accordance with the examination procedure referred to in article 7 . the chair may obtain the committee&#180 ; s opinion by means of the written procedure referred to in article 7 .


### when , after an examination procedure , the third country or countries concerned take measures which are considered satisfactory , and therefore no action by the union is required , the procedure may be suspended by the commission acting in accordance with the procedure referred to in article 7 . ### when , after an examination procedure , the third country or countries concerned take measures which are considered satisfactory , and therefore no action by the union is required , the procedure may be suspended by the commission acting in accordance with the advisory procedure referred to in article 7 .


### where , either after an examination procedure , or at any time before , during and after an international dispute settlement procedure , it appears that the most appropriate means to resolve a dispute arising from an obstacle to trade is the conclusion of an agreement with the third country or countries concerned , which may change the substantive rights of the union and of the third country or countries concerned , the procedure shall be suspended by the commission acting in accordance with the procedure referred to in article 7 , and negotiations shall be carried out according to the provisions of article 207 of the treaty . ### where , either after an examination procedure , or at any time before , during and after an international dispute settlement procedure , it appears that the most appropriate means to resolve a dispute arising from an obstacle to trade is the conclusion of an agreement with the third country or countries concerned , which may change the substantive rights of the union and of the third country or countries concerned , the procedure shall be suspended by the commission acting in accordance with the advisory procedure referred to in article 7 , and negotiations shall be carried out according to the provisions of article 207 of the treaty .


### where measures are unnecessary the investigation or proceedings shall be terminated . the commission shall terminate the investigation in accordance with the procedure referred to in article 10 . ### where measures are unnecessary the investigation or proceedings shall be terminated . the commission shall terminate the investigation in accordance with the examination procedure referred to in article 10 . the chair may obtain the committee´s opinion by means of the written procedure referred to in article 10 .


### where protective measures are unnecessary the investigation or proceedings shall be terminated . the commission shall terminate the investigation in accordance with the procedure referred to in article 25 . ### where protective measures are unnecessary the investigation or proceedings shall be terminated . the commission shall terminate the investigation in accordance with the advisory procedure referred to in article 25 . the chair may obtain the committee´s opinion by written procedure referred to in article 15 .


### where protective measures are unnecessary the investigation or proceeding shall be terminated . the commission shall terminate the investigation in accordance with the procedure referred to in article 15 . ### where protective measures are unnecessary the investigation or proceeding shall be terminated . the commission shall terminate the investigation in accordance with the advisory procedure referred to in article 15 . the chair may obtain the committee´s opinion by written procedure referred to in article 15 .


### for the purposes of the implementation of article 7 and , the commission shall be assisted by the committee on extra - territorial legislation . that committee shall be a committee within the meaning of regulation no [ &#8230 ; . / 2011 ] . ### for the purposes of the implementation of article 7 and , the commission shall be assisted by the committee on extra - territorial legislation . those implementing acts shall be adopted in accordance with the examination procedure referred to in paragraph 2 . the committee shall be a committee within the meaning of regulation no 182 / 2011 .


### the powers to adopt the delegated acts referred to in article 2 and shall be conferred on the commission for an indeterminate period of time . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the powers to adopt delegated acts are conferred on the commission subject to the conditions laid down in articles 24b and 24c . ### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article . 2 . the delegation of power referred to in article 2 and , article 4 and article 23 shall be conferred on the commission for a period of 5 years . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 5 - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extensions not later than three months before the end of each period . 3 . the delegation of power referred to in article 2 and , article 4 and article 23 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of power specified in that decision . it shall take effect on the day following the publication of the decision in the official journal of the european union or on a later date specified therein . it shall not affect the validity of any delegated acts already in force . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . a delegated act adopted pursuant to article 2 and , article 4 and article 23 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council .


### the powers to adopt the delegated acts referred to in article 2 and shall be conferred on the commission for an indeterminate period of time . ### the powers to adopt the delegated acts referred to in articles 2 and , 4 , and 23 shall be conferred on the commission for an indeterminate period of time .


### the powers to adopt the delegated acts referred to in article 1 shall be conferred on the commission for an indeterminate period of time . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the powers to adopt delegated acts are conferred on the commission subject to the conditions laid down in articles 11b and 11c . ### the commission shall be empowered to adopt delegated acts in accordance with article 1 concerning the addition or deletion of laws to or from the annex to this regulation .


### the delegation of power referred to in the second subparagraph of article 1 may be revoked at any time by the european parliament or by the council . 2 . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the commission within a reasonable time before the final decision is taken , indicating the delegated powers which could be subject to revocation and possible reasons for a revocation . 3 . the decision of revocation shall put an end to the delegation of the powers specified in that decision . it shall take effect immediately or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . it shall be published in the official journal of the european union . ### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article . 2 . the powers to adopt the delegated acts referred to in article 1 shall be conferred on the commission for an indeterminate period of time . 3 . the delegation of power referred to in article 1 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . 3a . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3b . a delegated act adopted pursuant to article 1 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . 3c . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the commission within a reasonable time before the final decision is taken , indicating the delegated powers which could be subject to revocation and possible reasons for a revocation . '


### insofar as it is appropriate to suspend the disputed or amended measure , such suspension shall be granted for a limited period of time by the commission , acting in accordance with the procedure referred to in article 3a . ### insofar as it is appropriate to suspend the disputed or amended measure , such suspension shall be granted for a limited period of time by the commission , acting in accordance with the advisory procedure referred to in article 3a .


### insofar as it is appropriate to suspend the non - disputed or amended measure , such suspension shall be granted for a limited period of time by the commission , acting in accordance with the procedure referred to in article 3a . ### insofar as it is appropriate to suspend the non - disputed or amended measure , such suspension shall be granted for a limited period of time by the commission , acting in accordance with the advisory procedure referred to in article 3a .


### the following paragraphs 3a and 3b are inserted : ' 3a . where reference is made to this paragraph , article [ 5 ] of regulation no [ xxxx / 2011 ] shall apply . 3b . where reference is made to this paragraph , article [ 8 ] of regulation no [ xxxx / 2011 ] shall apply in conjunction with article [ 5 ] thereof . ' ### paragraphs 2 , 3and 4 are deleted .


### the following paragraphs 3a and 3b are inserted : ' 3a . where reference is made to this paragraph , article [ 5 ] of regulation no [ xxxx / 2011 ] shall apply . 3b . where reference is made to this paragraph , article [ 8 ] of regulation no [ xxxx / 2011 ] shall apply in conjunction with article [ 5 ] thereof . ' ### paragraphs 2 , 3 and 4 are deleted .


### in article 27 , the following paragraphs 6 and 7 are added : 6 . where reference is made to this paragraph , article [ 5 ] of regulation no [ xxxx / 2011 ] shall apply . 7 . where reference is made to this paragraph , article [ 8 ] of regulation no [ xxxx / 2011 ] shall apply in conjunction with article [ 5 ] thereof . ' ### article 27 is replaced by the following : ' 1 . [ . . . ] the commission shall be assisted by a generalised preferences committee . that committee shall be a committee within the meaning of regulation no 182 / 2011 . [ . . . ] 5 . where reference is made to this paragraph , article 4 of regulation no 182 / 2011 shall apply . 6 . where reference is made to this paragraph , article 5 of regulation no 182 / 2011 shall apply . 7 . where reference is made to this paragraph , article 8 of regulation no 182 / 2011 shall apply in conjunction with article 4 thereof . 7a . where the opinion of the committee is to be obtained by written procedure , that procedure shall be terminated without result when , within the time - limit for delivery of the opinion , the chair of the committee so decides or a majority of committee members so request . '


### on the completion of the consultations , and if no other arrangement proves possible , the commission may decide in accordance with the procedure referred to in article 7a either not to act or to adopt appropriate measures provided for in articles 25 and 26 of the interim agreement , and thereafter articles 38 and 39 of the stabilisation and association agreement . in cases of urgency , article 7a shall apply . ### on the completion of the consultations , and if no other arrangement proves possible , the commission may decide in accordance with the examination procedure referred to in article 7fb either not to act or to adopt appropriate measures provided for in articles 25 and 26 of the interim agreement , and thereafter articles 38 and 39 of the stabilisation and association agreement . in cases of urgency , article 7fa shall apply .


### on the completion of the consultations , and if no other arrangement proves possible , the commission may decide in accordance with the procedure referred to in article 7a either not to act or to adopt appropriate measures provided for in articles 24 and 25 of the interim agreement , and thereafter articles 37 and 38 of the stabilisation and association agreement . in cases of urgency , article 7a shall apply . ### on the completion of the consultations , and if no other arrangement proves possible , the commission may decide in accordance with the examination procedure referred to in article 7fa either not to act or to adopt appropriate measures provided for in articles 24 and 25 of the interim agreement , and thereafter articles 37 and 38 of the stabilisation and association agreement . in cases of urgency , article 7fa shall apply .


### where exceptional and critical circumstances arise within the meaning of article 25 and article 26 of the interim agreement , and thereafter article 38 and article 39 of the stabilisation and association agreement , the commission may take immediate measures as provided for in articles 25 and 26 of the interim agreement , and thereafter articles 38 and 39 of the stabilisation and association agreement , in accordance with the procedure referred to in article 7a . in cases of urgency , article 7a shall apply . ### where exceptional and critical circumstances arise within the meaning of article 25 and article 26 of the interim agreement , and thereafter article 38 and article 39 of the stabilisation and association agreement , the commission may take immediate measures as provided for in articles 25 and 26 of the interim agreement , and thereafter articles 38 and 39 of the stabilisation and association agreement , in accordance with the advisory procedure referred to in article 7fa . in cases of urgency , article 7fa shall apply .


### where exceptional and critical circumstances arise within the meaning of article 24 and article 25 of the interim agreement , and thereafter article 37 and article 38 of the stabilisation and association agreement , the commission may take immediate measures as provided for in articles 24 and 25 of the interim agreement , and thereafter articles 37 and 38 of the stabilisation and association agreement , in accordance with the procedure referred to in article 7a . in cases of urgency , article 7a shall apply . ### where exceptional and critical circumstances arise within the meaning of article 24 and article 25 of the interim agreement , and thereafter article 37 and article 38 of the stabilisation and association agreement , the commission may take immediate measures as provided for in articles 24 and 25 of the interim agreement , and thereafter articles 37 and 38 of the stabilisation and association agreement , in accordance with the advisory procedure referred to in article 7fb . in cases of urgency , article 7fb shall apply .


### where necessary it shall adopt safeguard measures in accordance with the procedure referred to in article 7a , except in the cases of aid to which council regulation no 597 / 2009 of 11 june 2009 on protection against subsidised imports from countries not members of the european community applies , where measures shall be taken according to the procedures laid down in that regulation . ### where necessary it shall adopt safeguard measures in accordance with the examination procedure referred to in article 7fa , except in the cases of aid to which council regulation no 597 / 2009 of 11 june 2009 on protection against subsidised imports from countries not members of the european community applies , where measures shall be taken according to the procedures laid down in that regulation .


### as regards regulation no 427 / 2003 , the commission should be empowered to adopt the measures necessary for the implementation of that regulation in accordance with regulation no [ xxxx / 2011 ] of [ xx / yy / 2011 ] of the european parliament and of the council laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers . ### as regards regulation no 427 / 2003 , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty for the purpose of amending the annex i to that regulation . moreover , the commission should be empowered to adopt the measures necessary for the implementation of that regulation in accordance with regulation no 182 / 2011 of 16 / 02 / 2011 of the european parliament and of the council laying down the rules and general principles concerning mechanisms for control by member states of the commission’s exercise of implementing powers .


### the commission shall take such provisional measures in accordance with the procedure referred to in article 15 . in cases of urgency , article 15 shall apply . ### the commission shall take such provisional measures in accordance with the advisory procedure referred to in article 15 . in cases of urgency , article 15 shall apply .


### the commission shall take such measures in accordance with the procedure referred to in article 8a . in cases of urgency , article 8a shall apply . ### the commission shall take such measures in accordance with the advisory procedure referred to in article 8a . in cases of urgency , article 8a shall apply .


### the commission shall adopt such measures in accordance with the procedure referred to in article 8a . in cases of urgency , article 8a shall apply . ### the commission shall adopt such measures in accordance with the advisory procedure referred to in article 8a . in cases of urgency , article 8a shall apply .


### where the commission considers that any safeguard measure should be revoked or amended , it shall revoke or amend the safeguard measures . ### where the commission considers that any safeguard measure should be revoked or amended , it shall revoke or amend the safeguard measures in accordance with the examination procedure referred to in article 15 . '


### in the union interest , measures imposed pursuant to this regulation may be suspended by a decision of the commission for a period of nine months . the suspension may be extended for a further period , not exceeding one year , in accordance with the procedure referred to in article 15 . measures may only be suspended where market conditions have temporarily changed to an extent that market disruption would be unlikely to resume as a result of the suspension . measures may , at any time and after consultation , be reinstated if the reason for suspension is no longer applicable . ### in the union interest , measures imposed pursuant to this regulation may be suspended by a decision of the commission for a period of nine months . the suspension may be extended for a further period , not exceeding one year , in accordance with the advisory procedure referred to in article 15 . measures may only be suspended where market conditions have temporarily changed to an extent that market disruption would be unlikely to resume as a result of the suspension . measures may , at any time and after consultation , be reinstated if the reason for suspension is no longer applicable .


### where the commission considers that a combination of anti - dumping or anti - subsidy measures with safeguard tariff measures on the same imports could lead to effects greater than is desirable in terms of the union ' s trade defence policy , it may adopt such of the following measures as it deems appropriate in accordance with the procedure referred to in article 2a : ### where the commission considers that a combination of anti - dumping or anti - subsidy measures with safeguard tariff measures on the same imports could lead to effects greater than is desirable in terms of the union ' s trade defence policy , it may adopt such of the following measures implementing a legislative act as it deems appropriate in accordance with the examination procedure referred to in article 2a :


### for the purposes of articles 7 and 8 the commission shall be assisted by the committee on safeguards established by article 4 of council regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no [ &#8230 ; . / 2011 ] . ### for the purposes of articles 5 , 7 and 8 the commission shall be assisted by the committee set up by regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no 182 / 2011 .


### for the purposes of this chapter , the commission shall be assisted by the committee established by article 4 of council regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no [ &#8230 ; . / 2011 ] . ### for the purposes of articles 5 , 16 , 17 , 18 , and 20 , the commission shall be assisted by the committee established by article 4 of council regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no 182 / 2011 .


### for the purposes of articles 7 and 8 the commission shall be assisted by the committee on safeguards established by article 4 of council regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no [ &#8230 ; . / 2011 ] . ### for the purposes of articles 5 , 7 and 8 the commission shall be assisted by the committee on safeguards established by article 4 of council regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no 182 / 2011 .


### for the purposes of article 11 , the commission shall be assisted by the committee on safeguards established by article 4 of council regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no [ &#8230 ; . / 2011 ] . ### for the purposes of article 3 , 12 and 11 , the commission shall be assisted by the committee on safeguards established by article 4 of council regulation no 260 / 2009 . that committee shall be a committee within the meaning of regulation no 182 / 2011 .


### ' provisional measures shall be adopted in accordance with the procedure referred to in article 21 . in cases of urgency , article 21 shall apply . ' ### ' provisional measures shall be adopted in accordance with the advisory procedure referred to in article 21 . in cases of urgency , article 21 shall apply . '


### the decision to impose surveillance shall be taken by the commission in accordance with the procedure referred to in article 21 . ### the decision to impose surveillance shall be taken by the commission in accordance with the advisory procedure referred to in article 21 .


### where the commission finds that there is sufficient evidence of fraud , irregularities or systematic failure by moldova to comply , or to ensure compliance , with the rules of origin of products and the procedures related thereto and to provide administrative cooperation as referred to in article 2 , or a failure to comply with any of the other conditions defined in article 2 , it may take measures in accordance with the procedure referred to in article 11a to suspend in whole or in part the preferential arrangements provided for in this regulation for a period of not more than six months , provided that it has first : ' ### where the commission finds that there is sufficient evidence of fraud , irregularities or systematic failure by moldova to comply , or to ensure compliance , with the rules of origin of products and the procedures related thereto and to provide administrative cooperation as referred to in article 2 , or a failure to comply with any of the other conditions defined in article 2 , it may take measures in accordance with the advisory procedure referred to in article 11a to suspend in whole or in part the preferential arrangements provided for in this regulation for a period of not more than six months , provided that it has first : '


### the commission may suspend the preferential arrangements provided for in this regulation , in respect of all or of certain products originating in a beneficiary country , in accordance with the procedure referred to in article 27 , where it considers that there is sufficient evidence that temporary withdrawal would be justified for the reasons referred to in paragraphs 1 and 2 , provided that it has first : ### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to suspend the preferential arrangements provided for in this regulation , in respect of all or of certain products originating in a beneficiary country , where it considers that there is sufficient evidence that temporary withdrawal would be justified for the reasons referred to in paragraphs 1 and 2 , provided that it has first :


### in paragraph 3 , the second sentence is replaced by the following : ' the commission shall notify the beneficiary country concerned of this decision and shall publish a notice in the official journal of the european union , announcing that it intends to temporarily withdraw the preferential arrangements in respect of all or of certain products originating in a beneficiary country , unless , before the end of the period , the beneficiary country concerned makes a commitment to take the measures necessary to conform , in a reasonable period of time , with the conventions referred to in part a of annex iii . ' ### paragraph 3 is replaced by the following : ' where the commission considers that the findings justify temporary withdrawal for the reason referred to in article 15 , it shall decide , in accordance with the advisory procedure referred to in article 27 , to monitor and evaluate the situation in the beneficiary country concerned for a period of six months . the commission shall notify the beneficiary country concerned of this decision and shall publish a notice in the official journal of the european union , announcing that it intends to temporarily withdraw the preferential arrangements in respect of all or of certain products originating in a beneficiary country , unless , before the end of the period , the beneficiary country concerned makes a commitment to take the measures necessary to conform , in a reasonable period of time , with the conventions referred to in part a of annex iii . '


### where the commission considers temporary withdrawal to be necessary , it shall decide in accordance with the procedure referred to in article 27 . in the case referred to in paragraph 3 , the commission shall act at the end of the period referred to in that paragraph . ' ### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to decide on the temporary withdrawal . in the case referred to in paragraph 3 , the commission shall act at the end of the period referred to in that paragraph . '


### where the commission decides on temporary withdrawal , such decision shall enter into force six months after it is taken , unless the commission decides before then that the reasons justifying it no longer prevail . ### where the commission adopts a delegated act on temporary withdrawal , such decision shall enter into force six months after it is taken , unless the delegated acts has been revoked , or the commission decides to withdraw the delegated act before because the reasons justifying it no longer prevail .


### the investigation shall be completed within six months from the date of publication of the notice referred to in paragraph 2 . the commission may , in the case of exceptional circumstances , extend this period in accordance with the procedure referred to in article 27 . ### the investigation shall be completed within six months from the date of publication of the notice referred to in paragraph 2 . the commission may , in the case of exceptional circumstances , extend this period in accordance with the examination procedure referred to in article 27 .


### where exceptional circumstances requiring immediate action make an investigation impossible , the commission may , in accordance with the procedure referred to in article 27 , take any preventive measure which is strictly necessary . ### where exceptional circumstances requiring immediate action make an investigation impossible , the commission may , in accordance with the procedure referred to in article 27 , take any provisional measure which is strictly necessary . where a member state requests immediate intervention by the commission and where the conditions set out in paragraph 1 are met , the commission shall take a decision within five working days of receiving the request . provisional measures shall not apply for more than 200 days . should the provisional safeguard measures be repealed because the investigation shows that the conditions set out in this article are not met , any customs duty collected as a result of those provisional measures shall be refunded automatically .


### article 22 is deleted . ### article 22 is replaced by the following : ' 2 . prior surveillance measures shall be adopted by the commission in accordance with the advisory procedure referred to in article 27 . '


### for proceedings pursuant to article 10 , an investigation shall , whenever possible , be concluded within one year . in any event , such investigations shall be concluded within 13 months of initiation , in accordance with the findings made pursuant to article 13 for undertakings or the findings made pursuant to article 15 for definitive action . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . ### for proceedings pursuant to article 10 , an investigation shall , whenever possible , be concluded within 11 months . in any event , such investigations shall be concluded within 12 months of initiation , in accordance with the findings made pursuant to article 13 for undertakings or the findings made pursuant to article 15 for definitive action .


### for proceedings initiated pursuant to article 5 , an investigation shall , whenever possible , be concluded within one year . in any event , such investigations shall be concluded within 15 months of initiation , in accordance with the findings made pursuant to article 8 for undertakings or the findings made pursuant to article 9 for definitive action . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 9 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . ### for proceedings initiated pursuant to article 5 , an investigation shall , whenever possible , be concluded within one year . in any event , such investigations shall be concluded within 14 months of initiation , in accordance with the findings made pursuant to article 8 for undertakings or the findings made pursuant to article 9 for definitive action .


### where undertakings are accepted the investigation shall be terminated . the commission shall terminate the investigation in accordance with the procedure referred to in article 25 . ### where undertakings are accepted the investigation shall be terminated . the commission shall terminate the investigation in accordance with the examination procedure referred to in article 25 . the chair may obtain the committee´s opinion by written procedure referred to in article 15 .