# CE2013349EN.01014801.xml

| 29.11.2013 | EN | Official Journal of the European Union | CE 349/148 |
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29.11.2013

EN

Official Journal of the European Union

CE 349/148

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Tuesday 3 July 2012Customs enforcement of intellectual property rights ***I

P7_TA(2012)0272

European Parliament legislative resolution of 3 July 2012 on the proposal for a regulation of the European Parliament and of the Council concerning customs enforcement of intellectual property rights (COM(2011)0285 – C7-0139/2011 – 2011/0137(COD))

2013/C 349 E/22

(Ordinary legislative procedure: first reading)

The European Parliament,

The European Parliament

| — | having regard to the Commission proposal to Parliament and the Council (COM(2011)0285), |
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—

having regard to the Commission proposal to Parliament and the Council (COM(2011)0285),

| — | having regard to Article 294(2) and Article 207 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0139/2011), |
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—

having regard to Article 294(2) and Article 207 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0139/2011),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
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—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 55 of its Rules of Procedure, |
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—

having regard to Rule 55 of its Rules of Procedure,

| — | having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on International Trade and the Committee on Legal Affairs (A7-0046/2012), |
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—

having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on International Trade and the Committee on Legal Affairs (A7-0046/2012),

| 1. | Adopts its position at first reading hereinafter set out; |
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1.

Adopts its position at first reading hereinafter set out;

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
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2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
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3.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

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Tuesday 3 July 2012P7_TC1-COD(2011)0137

Position of the European Parliament adopted at first reading on 3 July 2012 with a view to the adoption of Regulation (EU) No .../2012 of the European Parliament and of the Council concerning customs enforcement of intellectual property rights

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 thereof,

Having regard to the proposal from the European Commission,

Having regard the opinion of the European Data Protection Supervisor (1),

After transmission of the draft legislative act to the national parliaments,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

| (1) | The Council of the European Union requested, in its Resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan (3), that Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (4) be reviewed. |
| --- | --- |

(1)

The Council of the European Union requested, in its Resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan (3), that Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (4) be reviewed.

| (2) | The marketing of goods infringing intellectual property rights does considerable damage to right-holders, law-abiding manufacturers and traders. It is also deceiving consumers, and could in some cases endanger their health and safety. Such goods should, in so far as is possible, be
  prevented from entering the customs territory of the Union and be
  kept off the market and measures should be adopted to deal with this unlawful activity without impeding legitimate trade.
  For this reason, consumers need to be well-informed about the risks involved in purchasing those goods. [Am. 1] |
| --- | --- |

(2)

The marketing of goods infringing intellectual property rights does considerable damage to right-holders, law-abiding manufacturers and traders. It is also deceiving consumers, and could in some cases endanger their health and safety. Such goods should, in so far as is possible, be
  prevented from entering the customs territory of the Union and be
  kept off the market and measures should be adopted to deal with this unlawful activity without impeding legitimate trade.
  For this reason, consumers need to be well-informed about the risks involved in purchasing those goods. [Am. 1]

| (3) | The review of Regulation (EC) No 1383/2003 showed that certain improvements to the legal framework were necessary to strengthen the enforcement of intellectual property rights
  by customs authorities
  , as well as to ensure appropriate legal clarity, thereby taking into account developments in the economic, commercial and legal areas. [Am. 2] |
| --- | --- |

(3)

The review of Regulation (EC) No 1383/2003 showed that certain improvements to the legal framework were necessary to strengthen the enforcement of intellectual property rights
  by customs authorities
  , as well as to ensure appropriate legal clarity, thereby taking into account developments in the economic, commercial and legal areas. [Am. 2]

| (4) | The customs authorities should be able to control goods, which are or should have been subject to customs supervision in the customs territory of the Union,
  including goods placed under a suspensive procedure,
  with a view to enforcing intellectual property rights. Enforcing intellectual property rights at the border, wherever the goods are, or should have been, under ‘customs supervision’ as defined by Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (5), makes good use of resources. Where goods are detained by customs at the border, one legal proceeding is required, whereas several separate proceedings would be required for the same level of enforcement for goods found on the market, which have been disaggregated and delivered to retailers. An exception should be made for goods released for free circulation under the end-use regime, as such goods remain under customs supervision, even though they have been released for free circulation. It is also appropriate not to apply this Regulation to goods carried by passengers in their personal luggage as long as these goods are for their own personal use and there are no indications that commercial traffic is involved. [Am. 3] |
| --- | --- |

(4)

The customs authorities should be able to control goods, which are or should have been subject to customs supervision in the customs territory of the Union,
  including goods placed under a suspensive procedure,
  with a view to enforcing intellectual property rights. Enforcing intellectual property rights at the border, wherever the goods are, or should have been, under ‘customs supervision’ as defined by Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (5), makes good use of resources. Where goods are detained by customs at the border, one legal proceeding is required, whereas several separate proceedings would be required for the same level of enforcement for goods found on the market, which have been disaggregated and delivered to retailers. An exception should be made for goods released for free circulation under the end-use regime, as such goods remain under customs supervision, even though they have been released for free circulation. It is also appropriate not to apply this Regulation to goods carried by passengers in their personal luggage as long as these goods are for their own personal use and there are no indications that commercial traffic is involved. [Am. 3]

| (5) | Regulation (EC) No 1383/2003 does not cover certain intellectual property rights and excludes certain infringements. In order to strengthen the enforcement of intellectual property rights, customs control should therefore be extended to other types of infringements, such as infringements resulting from parallel trade, as well as other infringements of rights already enforced by customs authorities but not covered by Regulation (EC) No 1383/2003. For the same

  that
  purpose it is appropriate to include in the scope of this Regulation, in addition to the rights already covered by Regulation (EC) No 1383/2003, trade names in so far as they are protected as exclusive property rights under national law, topographies of semiconductor products, utility models and devices to circumvent technological measures, as well as any exclusive intellectual property right established by Union legislation. [Am. 4] |
| --- | --- |

(5)

Regulation (EC) No 1383/2003 does not cover certain intellectual property rights and excludes certain infringements. In order to strengthen the enforcement of intellectual property rights, customs control should therefore be extended to other types of infringements, such as infringements resulting from parallel trade, as well as other infringements of rights already enforced by customs authorities but not covered by Regulation (EC) No 1383/2003. For the same

  that
  purpose it is appropriate to include in the scope of this Regulation, in addition to the rights already covered by Regulation (EC) No 1383/2003, trade names in so far as they are protected as exclusive property rights under national law, topographies of semiconductor products, utility models and devices to circumvent technological measures, as well as any exclusive intellectual property right established by Union legislation. [Am. 4]

| (5a) | Member States should commit sufficient resources to enable customs authorities to carry out their extended responsibilities and provide appropriate training for customs officials. The Commission and Member States should adopt guidelines to ensure the correct and uniform implementation of customs controls for the different types of infringements covered by this Regulation. [Am. 5] |
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(5a)

Member States should commit sufficient resources to enable customs authorities to carry out their extended responsibilities and provide appropriate training for customs officials. The Commission and Member States should adopt guidelines to ensure the correct and uniform implementation of customs controls for the different types of infringements covered by this Regulation. [Am. 5]

| (5b) | This Regulation, when fully implemented, should further contribute to a single market which ensures more effective protection to right-holders, fuels creativity and innovation and provides consumers with reliable and high-quality products, which should in turn strengthen cross-border transactions between consumers, businesses and traders. [Am. 6] |
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(5b)

This Regulation, when fully implemented, should further contribute to a single market which ensures more effective protection to right-holders, fuels creativity and innovation and provides consumers with reliable and high-quality products, which should in turn strengthen cross-border transactions between consumers, businesses and traders. [Am. 6]

| (5c) | The Commission should take all measures necessary to ensure harmonised application, without unnecessary delay, by the customs authorities of the new legal framework throughout the Union to ensure efficient enforcement of intellectual property rights, which would protect right-holders without hampering trade. The implementation of the Modernised Customs Code and in particular an inter-operable 'eCustoms' system could, in the future, facilitate such enforcement. [Am. 7] |
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(5c)

The Commission should take all measures necessary to ensure harmonised application, without unnecessary delay, by the customs authorities of the new legal framework throughout the Union to ensure efficient enforcement of intellectual property rights, which would protect right-holders without hampering trade. The implementation of the Modernised Customs Code and in particular an inter-operable 'eCustoms' system could, in the future, facilitate such enforcement. [Am. 7]

| (5d) | Member States face increasingly limited resources in the field of customs. Therefore, any new regulation should not result in additional financial burdens for national authorities. The promotion of new risk management technologies and strategies to maximise resources available to national authorities should be supported. [Am. 8] |
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(5d)

Member States face increasingly limited resources in the field of customs. Therefore, any new regulation should not result in additional financial burdens for national authorities. The promotion of new risk management technologies and strategies to maximise resources available to national authorities should be supported. [Am. 8]

| (6) | This Regulation contains procedural rules for customs authorities. Accordingly, this Regulation does not introduce

  set out
  any new criterion for ascertaining the existence of an infringement of the intellectual property law applicable. [Am. 9] |
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(6)

This Regulation contains procedural rules for customs authorities. Accordingly, this Regulation does not introduce

  set out
  any new criterion for ascertaining the existence of an infringement of the intellectual property law applicable. [Am. 9]

| (7) | This Regulation should not affect the provisions on the competence of courts, in particular those of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (6). |
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(7)

This Regulation should not affect the provisions on the competence of courts, in particular those of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (6).

| (8) | Any person, whether or not the holder of an intellectual property right, who is able to initiate legal proceedings in his/her own name with respect to a possible infringement of that right, should be entitled to submit an application for action by the customs authorities. |
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(8)

Any person, whether or not the holder of an intellectual property right, who is able to initiate legal proceedings in his/her own name with respect to a possible infringement of that right, should be entitled to submit an application for action by the customs authorities.

| (9) | In order to ensure that intellectual property rights are enforced throughout the Union, it is appropriate to provide that, where a person entitled to submit an application for action seeks enforcement of an intellectual property right covering the whole territory of the Union, that person may request the customs authorities of a Member State to take a decision requiring action by the customs authorities of that Member State and of any other Member State where enforcement of the intellectual property right is sought. |
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(9)

In order to ensure that intellectual property rights are enforced throughout the Union, it is appropriate to provide that, where a person entitled to submit an application for action seeks enforcement of an intellectual property right covering the whole territory of the Union, that person may request the customs authorities of a Member State to take a decision requiring action by the customs authorities of that Member State and of any other Member State where enforcement of the intellectual property right is sought.

| (10) | In order to ensure the swift enforcement of intellectual property rights, it should be provided that, where the customs authorities suspect, on the basis of adequate evidence

  having sufficient reason to believe this
  , that goods under their supervision infringe intellectual property rights, those customs authorities may suspend the release or detain the goods whether at their own initiative or upon application, in order to enable the persons entitled to submit an application for action of the customs authorities to initiate proceedings for determining whether an intellectual property right has been infringed. [Am. 10] |
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(10)

In order to ensure the swift enforcement of intellectual property rights, it should be provided that, where the customs authorities suspect, on the basis of adequate evidence

  having sufficient reason to believe this
  , that goods under their supervision infringe intellectual property rights, those customs authorities may suspend the release or detain the goods whether at their own initiative or upon application, in order to enable the persons entitled to submit an application for action of the customs authorities to initiate proceedings for determining whether an intellectual property right has been infringed. [Am. 10]

| (10a) | Where goods in transit are suspected to be an imitation or a copy of a product protected in the Union by an intellectual property right, the declarant or holder of the goods should bear the burden of proving the final destination of the goods. The final destination of the goods should be presumed to be the market of the Union in the absence of clear and convincing evidence to the contrary provided by the declarant, holder or owner of the goods. The Commission should adopt guidelines which will provide criteria for customs authorities to effectively assess their risk of deviation onto the market of the Union, taking into account the relevant case-law of the Court of Justice of the European Union. [Am. 11] |
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(10a)

Where goods in transit are suspected to be an imitation or a copy of a product protected in the Union by an intellectual property right, the declarant or holder of the goods should bear the burden of proving the final destination of the goods. The final destination of the goods should be presumed to be the market of the Union in the absence of clear and convincing evidence to the contrary provided by the declarant, holder or owner of the goods. The Commission should adopt guidelines which will provide criteria for customs authorities to effectively assess their risk of deviation onto the market of the Union, taking into account the relevant case-law of the Court of Justice of the European Union. [Am. 11]

| (11) | Where goods suspected of infringing intellectual property rights are not counterfeit or pirated goods, it may be difficult to determine upon mere visual examination by customs authorities whether an intellectual property right might be infringed. It is therefore appropriate to provide that proceedings should be initiated, unless the parties concerned, namely the holder of the goods and the right-holder, agree to abandon the goods for destruction. It should be for the competent authorities dealing with such proceedings to determine whether an intellectual property right has been infringed and to take appropriate decisions concerning the infringements of intellectual property rights concerned.
  [Am. 12] |
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(11)

Where goods suspected of infringing intellectual property rights are not counterfeit or pirated goods, it may be difficult to determine upon mere visual examination by customs authorities whether an intellectual property right might be infringed. It is therefore appropriate to provide that proceedings should be initiated, unless the parties concerned, namely the holder of the goods and the right-holder, agree to abandon the goods for destruction. It should be for the competent authorities dealing with such proceedings to determine whether an intellectual property right has been infringed and to take appropriate decisions concerning the infringements of intellectual property rights concerned.
  [Am. 12]

| (12) | Regulation (EC) No 1383/2003 allowed Member States to provide for a procedure allowing the destruction of certain goods without there being any obligation to initiate proceedings to establish whether an intellectual property right has been infringed. As recognised in the European Parliament Resolution of 18 December 2008 on the impact of counterfeiting on international trade (7), this procedure has proved very successful in the Member States where it has been available. Therefore, such procedure should be made compulsory for those visible

  with regard to all
  infringements that are easy to identify upon mere visual examination by the customs authorities and should be applied at the right-holder’s request, where
  the right-holder has confirmed the infringement of an intellectual property right and agreed to destruction and where
  the declarant or holder of the goods does not object to destruction. [Am. 13] |
| --- | --- |

(12)

Regulation (EC) No 1383/2003 allowed Member States to provide for a procedure allowing the destruction of certain goods without there being any obligation to initiate proceedings to establish whether an intellectual property right has been infringed. As recognised in the European Parliament Resolution of 18 December 2008 on the impact of counterfeiting on international trade (7), this procedure has proved very successful in the Member States where it has been available. Therefore, such procedure should be made compulsory for those visible

  with regard to all
  infringements that are easy to identify upon mere visual examination by the customs authorities and should be applied at the right-holder’s request, where
  the right-holder has confirmed the infringement of an intellectual property right and agreed to destruction and where
  the declarant or holder of the goods does not object to destruction. [Am. 13]

| (13) | In order to reduce to the minimum the administrative burden and costs,
  without prejudice to the consumer's right to be duly informed within
  a
  reasonable time of the legal basis of the actions taken by the customs authorities,
  a specific procedure should be introduced for small consignments of counterfeit and pirated goods, which would allow for goods to be destroyed without the agreement of the right-holder
  where the right-holder has requested the use of the specific procedure in his application
  . In order to establish the thresholds under which consignments are to be considered as small consignments, this Regulation should delegate to the Commission the power to adopt non-legislative acts of general application in accordance with Article 290 of the Treaty on the Functioning of the European Union. It is of importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level.
  [Am. 14] |
| --- | --- |

(13)

In order to reduce to the minimum the administrative burden and costs,
  without prejudice to the consumer's right to be duly informed within
  a
  reasonable time of the legal basis of the actions taken by the customs authorities,
  a specific procedure should be introduced for small consignments of counterfeit and pirated goods, which would allow for goods to be destroyed without the agreement of the right-holder
  where the right-holder has requested the use of the specific procedure in his application
  . In order to establish the thresholds under which consignments are to be considered as small consignments, this Regulation should delegate to the Commission the power to adopt non-legislative acts of general application in accordance with Article 290 of the Treaty on the Functioning of the European Union. It is of importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level.
  [Am. 14]

| (14) | The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
  [Am. 15] |
| --- | --- |

(14)

The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
  [Am. 15]

| (15) | For further legal clarity and in order to protect the interests of legitimate traders from possible abuse of the border enforcement provisions, it is appropriate to modify the time limits for detaining goods suspected of infringing an intellectual property right, the conditions in which information about consignments is to be passed on to right-holders by customs authorities,
  and
  the conditions for applying the procedure allowing for destruction of the goods under customs control for suspected infringements of intellectual property rights
  .

  other than for counterfeit and pirated goods and

  Where customs authorities take action following the granting of an application, it is also appropriate
  to introduce a provision allowing the holder of the goods to express his/her views before the customs administration takes a decision which would adversely affect him/her

  suspends the release of or detains goods suspected of infringing intellectual property rights that are not counterfeit or pirated goods, as it may be difficult for customs authorities to determine upon mere visual examination whether an intellectual property right might be infringed
  . [Am. 16] |
| --- | --- |

(15)

For further legal clarity and in order to protect the interests of legitimate traders from possible abuse of the border enforcement provisions, it is appropriate to modify the time limits for detaining goods suspected of infringing an intellectual property right, the conditions in which information about consignments is to be passed on to right-holders by customs authorities,
  and
  the conditions for applying the procedure allowing for destruction of the goods under customs control for suspected infringements of intellectual property rights
  .

  other than for counterfeit and pirated goods and

  Where customs authorities take action following the granting of an application, it is also appropriate
  to introduce a provision allowing the holder of the goods to express his/her views before the customs administration takes a decision which would adversely affect him/her

  suspends the release of or detains goods suspected of infringing intellectual property rights that are not counterfeit or pirated goods, as it may be difficult for customs authorities to determine upon mere visual examination whether an intellectual property right might be infringed
  . [Am. 16]

| (16) | Taking into account the provisional and preventive character of the measures adopted by the customs authorities in this field and the conflicting interests of the parties affected by the measures, some aspects of the procedures should be adapted to ensure a smooth application of this Regulation, whilst respecting the rights of the concerned parties. Thus, with respect to the various notifications envisaged by this Regulation, the customs authorities should notify the most appropriate person, on the basis of the documents concerning the customs treatment or of the situation in which the goods are placed. The periods laid down in this Regulation for the required notifications should be counted from the time those notifications are sent by the customs authorities in order to align all periods of notifications sent to the concerned parties

  have been received
  . The period allowing for a right to be heard before an adverse decision is taken

  the suspension of release or detention of goods other than counterfeit or pirated goods
  should be three working days, given that

  after receipt where
  the holders of decisions granting applications for action have voluntarily requested the customs authorities to take action and that the declarants or holders of the goods must be aware of the particular situation of their goods when placed under customs supervision. In the case of the specific procedure for small consignments, where consumers are likely to be directly concerned and cannot be expected to have the same level of diligence as other economic operators usually involved in the accomplishment of customs formalities, that

  the right to be heard should be granted for all types of goods and the
  period
  allowing for that right
  should be significantly extended.
  Taking into account the potential workload of the customs enforcement provided for in this Regulation, the customs authorities should give preference to handling large consignments. [Am. 17] |
| --- | --- |

(16)

Taking into account the provisional and preventive character of the measures adopted by the customs authorities in this field and the conflicting interests of the parties affected by the measures, some aspects of the procedures should be adapted to ensure a smooth application of this Regulation, whilst respecting the rights of the concerned parties. Thus, with respect to the various notifications envisaged by this Regulation, the customs authorities should notify the most appropriate person, on the basis of the documents concerning the customs treatment or of the situation in which the goods are placed. The periods laid down in this Regulation for the required notifications should be counted from the time those notifications are sent by the customs authorities in order to align all periods of notifications sent to the concerned parties

  have been received
  . The period allowing for a right to be heard before an adverse decision is taken

  the suspension of release or detention of goods other than counterfeit or pirated goods
  should be three working days, given that

  after receipt where
  the holders of decisions granting applications for action have voluntarily requested the customs authorities to take action and that the declarants or holders of the goods must be aware of the particular situation of their goods when placed under customs supervision. In the case of the specific procedure for small consignments, where consumers are likely to be directly concerned and cannot be expected to have the same level of diligence as other economic operators usually involved in the accomplishment of customs formalities, that

  the right to be heard should be granted for all types of goods and the
  period
  allowing for that right
  should be significantly extended.
  Taking into account the potential workload of the customs enforcement provided for in this Regulation, the customs authorities should give preference to handling large consignments. [Am. 17]

| (17) | Under the "Declaration on the TRIPS Agreement and Public Health" adopted by the Doha World Trade Organisation (WTO) Ministerial Conference on 14 November 2001, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In

  It is therefore of
  particular
  importance that customs authorities ensure that any measures taken up by them are in line
  with regard to

  the Union's international commitments and its development cooperation policy under Article 208 of the Treaty on the Functioning of the European Union, and do not detain or suspend the release of generic
  medicines the passage of which across this

  the
  territory of the European Union, with or without transshipment, warehousing, breaking bulk, or changes in the mode or means of transport, is only a portion of a complete journey beginning and terminating beyond the territory of the Union, customs authorities should, when assessing a risk of infringement of intellectual property rights, take account of any substantial likelihood of diversion of these goods onto the market of

  where there is no clear and convincing evidence that they are intended for sale in
  the Union. [Am. 109, 126 and 153] |
| --- | --- |

(17)

Under the "Declaration on the TRIPS Agreement and Public Health" adopted by the Doha World Trade Organisation (WTO) Ministerial Conference on 14 November 2001, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In

  It is therefore of
  particular
  importance that customs authorities ensure that any measures taken up by them are in line
  with regard to

  the Union's international commitments and its development cooperation policy under Article 208 of the Treaty on the Functioning of the European Union, and do not detain or suspend the release of generic
  medicines the passage of which across this

  the
  territory of the European Union, with or without transshipment, warehousing, breaking bulk, or changes in the mode or means of transport, is only a portion of a complete journey beginning and terminating beyond the territory of the Union, customs authorities should, when assessing a risk of infringement of intellectual property rights, take account of any substantial likelihood of diversion of these goods onto the market of

  where there is no clear and convincing evidence that they are intended for sale in
  the Union. [Am. 109, 126 and 153]

| (17a) | Medicines that bear a false trademark or trade description misrepresent their origin and quality level and thus should be treated as falsified medicines under Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (8). Adequate measures should be taken to prevent such products from reaching patients and consumers, without hindering legal generic medicine from transiting the customs territory of the Union. By ... (9) the Commission should present a report analysing the effectiveness of current customs measures aimed at combating trade in falsified medicines, and the possible negative impact on the access of generic medicine in relation to this. [Am. 110, 127 and 154] |
| --- | --- |

(17a)

Medicines that bear a false trademark or trade description misrepresent their origin and quality level and thus should be treated as falsified medicines under Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (8). Adequate measures should be taken to prevent such products from reaching patients and consumers, without hindering legal generic medicine from transiting the customs territory of the Union. By ... (9) the Commission should present a report analysing the effectiveness of current customs measures aimed at combating trade in falsified medicines, and the possible negative impact on the access of generic medicine in relation to this. [Am. 110, 127 and 154]

| (17b) | In order to step up action against infringements of intellectual property rights, the European Observatory on Infringements of Intellectual Property Rights should play an important role in providing customs authorities with useful information enabling them to act quickly and effectively. [Am. 20] |
| --- | --- |

(17b)

In order to step up action against infringements of intellectual property rights, the European Observatory on Infringements of Intellectual Property Rights should play an important role in providing customs authorities with useful information enabling them to act quickly and effectively. [Am. 20]

| (17c) | Countering intellectual property rights infringements at the Union's external borders should be combined with targeted efforts at source. This requires cooperation both with third countries and at international level, where the Commission and Member States should build respect and promote high standards of protection for intellectual property rights. This should consist of endorsing the inclusion and enforcement of intellectual property rights in trade agreements, of technical cooperation, of encouraging discussion in the various international fora, of communication and exchange of information, as well as of further steps in operational cooperation with third countries and the industries concerned. [Am. 21] |
| --- | --- |

(17c)

Countering intellectual property rights infringements at the Union's external borders should be combined with targeted efforts at source. This requires cooperation both with third countries and at international level, where the Commission and Member States should build respect and promote high standards of protection for intellectual property rights. This should consist of endorsing the inclusion and enforcement of intellectual property rights in trade agreements, of technical cooperation, of encouraging discussion in the various international fora, of communication and exchange of information, as well as of further steps in operational cooperation with third countries and the industries concerned. [Am. 21]

| (17d) | With a view to eliminating international trade in goods infringing intellectual property rights, Article 69 of the TRIPS Agreement provides that WTO Members are to promote the exchange of information between customs authorities on trade in goods infringing intellectual property rights. Such exchange of information should allow trafficking networks to be tracked in order to stop the manufacture and distribution of goods infringing intellectual property rights at an earlier stage of the supply chain. It is therefore necessary to establish the conditions for the exchange of information between customs authorities in the Union and relevant authorities in third countries, including on data protection. [Am. 22] |
| --- | --- |

(17d)

With a view to eliminating international trade in goods infringing intellectual property rights, Article 69 of the TRIPS Agreement provides that WTO Members are to promote the exchange of information between customs authorities on trade in goods infringing intellectual property rights. Such exchange of information should allow trafficking networks to be tracked in order to stop the manufacture and distribution of goods infringing intellectual property rights at an earlier stage of the supply chain. It is therefore necessary to establish the conditions for the exchange of information between customs authorities in the Union and relevant authorities in third countries, including on data protection. [Am. 22]

| (17e) | In line with the Union's goal of strengthening international cooperation in the fight against counterfeiting, piracy and illicit parallel trade in goods infringing the intellectual property of registered right-holders, the European Observatory on Infringements of Intellectual Property Rights has a key role to play by providing all customs authorities of Member States with relevant and timely information to conduct appropriate controls of authorised importers and distributors of goods suspected of infringing an intellectual property right in the internal market as well as exporters thereof to foreign markets. That role could be further enhanced by the creation of a database of genuine Union products and services protected by registered trademarks, designs and patents and which could also be made available to foreign customs authorities cooperating with the Union on better intellectual property rights protection and enforcement. [Am. 23] |
| --- | --- |

(17e)

In line with the Union's goal of strengthening international cooperation in the fight against counterfeiting, piracy and illicit parallel trade in goods infringing the intellectual property of registered right-holders, the European Observatory on Infringements of Intellectual Property Rights has a key role to play by providing all customs authorities of Member States with relevant and timely information to conduct appropriate controls of authorised importers and distributors of goods suspected of infringing an intellectual property right in the internal market as well as exporters thereof to foreign markets. That role could be further enhanced by the creation of a database of genuine Union products and services protected by registered trademarks, designs and patents and which could also be made available to foreign customs authorities cooperating with the Union on better intellectual property rights protection and enforcement. [Am. 23]

| (18) | In the interest of efficiency, the provisions of Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs or agricultural matters (10), should apply. |
| --- | --- |

(18)

In the interest of efficiency, the provisions of Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs or agricultural matters (10), should apply.

| (19) | The liability of the customs authorities should be governed by the legislation of the Member States, though the granting by the customs authorities of an application for action should not entitle the holder of the decision to compensation in the event that such goods are not detected by a customs office and are released or no action is taken to detain them. |
| --- | --- |

(19)

The liability of the customs authorities should be governed by the legislation of the Member States, though the granting by the customs authorities of an application for action should not entitle the holder of the decision to compensation in the event that such goods are not detected by a customs office and are released or no action is taken to detain them.

| (20) | Given that customs authorities take action upon prior application, the holder of the decision granting an application for action by the customs authorities should reimburse all the costs incurred by the customs authorities in taking action to enforce his or her intellectual property rights. Nevertheless, this should not preclude the holder of the decision from seeking

  should have the right to seek
  compensation from the infringer or other persons that might be considered liable under the legislation of the Member State concerned
  , for example certain intermediaries such as carriers
  . Costs and damages incurred by persons other than customs administrations as a result of a customs action, where the goods are detained on the basis of a claim of a third party based on intellectual property, should be governed by the specific legislation in each particular case. [Am. 24] |
| --- | --- |

(20)

Given that customs authorities take action upon prior application, the holder of the decision granting an application for action by the customs authorities should reimburse all the costs incurred by the customs authorities in taking action to enforce his or her intellectual property rights. Nevertheless, this should not preclude the holder of the decision from seeking

  should have the right to seek
  compensation from the infringer or other persons that might be considered liable under the legislation of the Member State concerned
  , for example certain intermediaries such as carriers
  . Costs and damages incurred by persons other than customs administrations as a result of a customs action, where the goods are detained on the basis of a claim of a third party based on intellectual property, should be governed by the specific legislation in each particular case. [Am. 24]

| (20a) | This Regulation introduces the possibility for customs authorities to allow goods abandoned for destruction to be moved, under customs supervision, between different places within the customs territory of the Union. Customs authorities should be encouraged to make use of that possibility in order to facilitate the economically and environmentally sound destruction of those goods, as well as for educational and exhibition purposes, while providing for appropriate security measures. [Am. 25] |
| --- | --- |

(20a)

This Regulation introduces the possibility for customs authorities to allow goods abandoned for destruction to be moved, under customs supervision, between different places within the customs territory of the Union. Customs authorities should be encouraged to make use of that possibility in order to facilitate the economically and environmentally sound destruction of those goods, as well as for educational and exhibition purposes, while providing for appropriate security measures. [Am. 25]

| (21) | Customs enforcement of intellectual property law will entail the exchange of data on decisions relating to applications for action. Such processing of data covers also personal data which should be carried out in accordance with Union law, as set out, in particular, in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (11) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by Community institutions and bodies and on the free movement of such data (12). |
| --- | --- |

(21)

Customs enforcement of intellectual property law will entail the exchange of data on decisions relating to applications for action. Such processing of data covers also personal data which should be carried out in accordance with Union law, as set out, in particular, in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (11) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by Community institutions and bodies and on the free movement of such data (12).

| (21a) | The following elements of the database should be defined in Union legislation: the entity which will control and manage the database and the entity in charge of ensuring the security of the processing of the data contained in the database. Introducing any type of possible interoperability or exchange should first and foremost comply with the purpose limitation principle, namely that data should be used for the purpose for which the database has been established, and no further exchange or interconnection should be allowed other than for that purpose. [Am. 26] |
| --- | --- |

(21a)

The following elements of the database should be defined in Union legislation: the entity which will control and manage the database and the entity in charge of ensuring the security of the processing of the data contained in the database. Introducing any type of possible interoperability or exchange should first and foremost comply with the purpose limitation principle, namely that data should be used for the purpose for which the database has been established, and no further exchange or interconnection should be allowed other than for that purpose. [Am. 26]

| (22) | In order to ensure uniform conditions for the implementation of the provisions concerning the forms for the application for action by the customs authorities and for requesting the extension of the period during which customs authorities are to take action, implementing powers should be conferred on the Commission, namely to establish standard forms. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (13). |
| --- | --- |

(22)

In order to ensure uniform conditions for the implementation of the provisions concerning the forms for the application for action by the customs authorities and for requesting the extension of the period during which customs authorities are to take action, implementing powers should be conferred on the Commission, namely to establish standard forms. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (13).

| (23) | Although the subject of the provisions of this Regulation to be implemented falls within the scope of the common commercial policy, given the nature and impacts of the implementing acts, the advisory procedure should be used for their adoption. |
| --- | --- |

(23)

Although the subject of the provisions of this Regulation to be implemented falls within the scope of the common commercial policy, given the nature and impacts of the implementing acts, the advisory procedure should be used for their adoption.

| (24) | Regulation (EC) No 1383/2003 should be repealed, |
| --- | --- |

(24)

Regulation (EC) No 1383/2003 should be repealed,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1.   This Regulation sets out the conditions and procedures for action by the customs authorities where goods suspected of infringing an intellectual property right are, or should have been, subject to customs supervision within the customs territory of the Union.

2.   This Regulation shall not apply to goods that have been released for free circulation under the end-use regime within the meaning of Article 82 of Regulation (EEC) No 2913/92.

3.   This Regulation shall not affect in any way the laws of the Member States and of the Union on intellectual property.

4.   This Regulation shall not apply to goods of a non-commercial nature contained in travellers’ personal luggage.

4a.
     
  This Regulation shall apply to goods in transit through the customs territory of the Union which are suspected of infringing an intellectual property right. [Am. 27]

Article 2

Definitions

For the purposes of this Regulation:

| (1) | ‘intellectual property rights’ means:






  (a) | a trade mark; |
| --- | --- | --- |

(1)

‘intellectual property rights’ means:

(a)

a trade mark;

| (b) | a design; |
| --- | --- |

(b)

a design;

| (c) | a copyright or any related right as provided for by the legislation of a Member State; |
| --- | --- |

(c)

a copyright or any related right as provided for by the legislation of a Member State;

| (d) | a geographical indication; |
| --- | --- |

(d)

a geographical indication;

| (e) | a patent as provided for by the legislation of a Member State; |
| --- | --- |

(e)

a patent as provided for by the legislation of a Member State;

| (f) | a supplementary protection certificate for medicinal products as provided for in Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (14); |
| --- | --- |

(f)

a supplementary protection certificate for medicinal products as provided for in Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (14);

| (g) | a supplementary protection certificate for plant protection products as provided for in Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (15); |
| --- | --- |

(g)

a supplementary protection certificate for plant protection products as provided for in Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (15);

| (h) | a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (16); |
| --- | --- |

(h)

a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (16);

| (i) | a plant variety right as provided for by the legislation of a Member State; |
| --- | --- |

(i)

a plant variety right as provided for by the legislation of a Member State;

| (j) | a topography of semiconductor product as provided for by the legislation of a Member State; |
| --- | --- |

(j)

a topography of semiconductor product as provided for by the legislation of a Member State;

| (k) | a utility model as provided for

  insofar as it is protected as an exclusive intellectual property right
  by the legislation of a Member State; [Am. 28] |
| --- | --- |

(k)

a utility model as provided for

  insofar as it is protected as an exclusive intellectual property right
  by the legislation of a Member State; [Am. 28]

| (l) | a trade name in so far as it is protected as an exclusive intellectual property right by the legislation of a Member State; |
| --- | --- |

(l)

a trade name in so far as it is protected as an exclusive intellectual property right by the legislation of a Member State;

| (m) | any other right that is established as an exclusive intellectual property right by Union legislation; |
| --- | --- |

(m)

any other right that is established as an exclusive intellectual property right by Union legislation;

| (2) | ‘trade mark’ means:






  (a) | a Community trade mark as provided for in Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (17); |
| --- | --- | --- |

(2)

‘trade mark’ means:

(a)

a Community trade mark as provided for in Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (17);

| (b) | a trade mark registered in a Member State, or, in the case of Belgium, the Netherlands or Luxembourg, at the Benelux Office for Intellectual Property; |
| --- | --- |

(b)

a trade mark registered in a Member State, or, in the case of Belgium, the Netherlands or Luxembourg, at the Benelux Office for Intellectual Property;

| (c) | a trade mark registered under international arrangements which have effect in a Member State; |
| --- | --- |

(c)

a trade mark registered under international arrangements which have effect in a Member State;

| (d) | a trade mark registered under international arrangements which have effect in the Union; |
| --- | --- |

(d)

a trade mark registered under international arrangements which have effect in the Union;

| (3) | ‘design’ means:






  (a) | a Community design as provided for in Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (18); |
| --- | --- | --- |

(3)

‘design’ means:

(a)

a Community design as provided for in Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (18);

| (b) | a design registered in a Member State; |
| --- | --- |

(b)

a design registered in a Member State;

| (c) | a design registered under international arrangements which have effect in a Member State; |
| --- | --- |

(c)

a design registered under international arrangements which have effect in a Member State;

| (d) | a design registered under international arrangements which have effect in the Union; |
| --- | --- |

(d)

a design registered under international arrangements which have effect in the Union;

| (4) | ‘geographical indication’ means:






  (a) | a geographical indication or designation of origin protected for agricultural products and foodstuff as provided for in Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (19); |
| --- | --- | --- |

(4)

‘geographical indication’ means:

(a)

a geographical indication or designation of origin protected for agricultural products and foodstuff as provided for in Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (19);

| (b) | a designation of origin or geographical indication for wine as provided for in Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (20); |
| --- | --- |

(b)

a designation of origin or geographical indication for wine as provided for in Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (20);

| (c) | a geographical designation for aromatised wine as provided for in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine- based drinks and aromatized wine-product cocktails (21); |
| --- | --- |

(c)

a geographical designation for aromatised wine as provided for in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine- based drinks and aromatized wine-product cocktails (21);

| (d) | a geographical indication of spirit drinks as provided for in Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (22); |
| --- | --- |

(d)

a geographical indication of spirit drinks as provided for in Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (22);

| (e) | a geographical indication for products other than wines, spirits, agricultural products or foodstuff in so far as it is established as an exclusive intellectual property right by legislation of a Member State or the Union; |
| --- | --- |

(e)

a geographical indication for products other than wines, spirits, agricultural products or foodstuff in so far as it is established as an exclusive intellectual property right by legislation of a Member State or the Union;

| (f) | a geographical indication as provided for in Agreements between the Union and third countries and as such listed in those Agreements; |
| --- | --- |

(f)

a geographical indication as provided for in Agreements between the Union and third countries and as such listed in those Agreements;

| (5) | ‘counterfeit goods’ means:






  (a) | goods which are subject of an action infringing a trade mark and bear without authorisation a trade mark identical to the trade mark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trade mark
  , as well as any trade mark sign, even if presented separately, and packaging bearing the trade marks of the counterfeit goods
  ; [Am. 29] |
| --- | --- | --- |

(5)

‘counterfeit goods’ means:

(a)

goods which are subject of an action infringing a trade mark and bear without authorisation a trade mark identical to the trade mark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trade mark
  , as well as any trade mark sign, even if presented separately, and packaging bearing the trade marks of the counterfeit goods
  ; [Am. 29]

| (b) | goods which are subject of an action infringing a geographical indication and bear or are described by a name or term protected in respect of that geographical indication; |
| --- | --- |

(b)

goods which are subject of an action infringing a geographical indication and bear or are described by a name or term protected in respect of that geographical indication;

| (6) | ‘pirated goods’ means goods which are the subject of an action infringing a copyright or related right or a design and which are or contain copies made without the consent of the holder of a copyright or related right or a design, regardless of whether it is registered, or of a person authorised by that holder in the country of production; |
| --- | --- |

(6)

‘pirated goods’ means goods which are the subject of an action infringing a copyright or related right or a design and which are or contain copies made without the consent of the holder of a copyright or related right or a design, regardless of whether it is registered, or of a person authorised by that holder in the country of production;

| (7) | ‘goods suspected of infringing an intellectual property right’ means goods with regard to which there is adequate evidence

  are sufficient reasons
  to satisfy customs authorities that, in the Member State where these goods are found, are prima facie: [Am. 30]







  (a) | goods which are subject of an action infringing an intellectual property right under

  in
  the law of the Union or of that Member State
  where the goods are found
  ; [Am. 31] |
| --- | --- | --- |

(7)

‘goods suspected of infringing an intellectual property right’ means goods with regard to which there is adequate evidence

  are sufficient reasons
  to satisfy customs authorities that, in the Member State where these goods are found, are prima facie: [Am. 30]

(a)

goods which are subject of an action infringing an intellectual property right under

  in
  the law of the Union or of that Member State
  where the goods are found
  ; [Am. 31]

| (b) | devices, products or components which circumvent any technology, device or component that, in the normal course of its operation, prevents or restricts acts in respect of works which are not authorised by the right-holder of any copyright or right related to copyright and which infringe an intellectual property right under the law of that Member state; |
| --- | --- |

(b)

devices, products or components which circumvent any technology, device or component that, in the normal course of its operation, prevents or restricts acts in respect of works which are not authorised by the right-holder of any copyright or right related to copyright and which infringe an intellectual property right under the law of that Member state;

| (c) | any mould or matrix which is specifically designed or adapted for the manufacture of goods infringing an intellectual property right, if such moulds or matrices infringe the right-holder's rights under Union law or

  in
  the law of that Member State
  where the goods are found
  ; [Am. 32] |
| --- | --- |

(c)

any mould or matrix which is specifically designed or adapted for the manufacture of goods infringing an intellectual property right, if such moulds or matrices infringe the right-holder's rights under Union law or

  in
  the law of that Member State
  where the goods are found
  ; [Am. 32]

| (8) | ‘application’ means a request made to the customs authorities to take action where goods are suspected of infringing an intellectual property right; |
| --- | --- |

(8)

‘application’ means a request made to the customs authorities to take action where goods are suspected of infringing an intellectual property right;

| (9) | ‘national application’ means an application requesting the customs authorities of a Member State to take action in that Member State; |
| --- | --- |

(9)

‘national application’ means an application requesting the customs authorities of a Member State to take action in that Member State;

| (10) | ‘Union application’ means an application submitted in one Member State and requesting the customs authorities of that Member State and of one or more other Member States to take action in their respective Member States; |
| --- | --- |

(10)

‘Union application’ means an application submitted in one Member State and requesting the customs authorities of that Member State and of one or more other Member States to take action in their respective Member States;

| (11) | ‘applicant’ means the person who submits an application in his or her own name; |
| --- | --- |

(11)

‘applicant’ means the person who submits an application in his or her own name;

| (12) | ‘holder of the goods’ means the person who is the owner of the goods or who has a similar right of disposal over them or who has physical control over them; |
| --- | --- |

(12)

‘holder of the goods’ means the person who is the owner of the goods or who has a similar right of disposal over them or who has physical control over them;

| (13) | ‘declarant’ means the declarant as referred to

  person lodging a declaration
  in Article 4(18) of Regulation (EEC) No 2913/92

  his or her own name or the person in whose name a customs declaration is made
  ; [Am. 33] |
| --- | --- |

(13)

‘declarant’ means the declarant as referred to

  person lodging a declaration
  in Article 4(18) of Regulation (EEC) No 2913/92

  his or her own name or the person in whose name a customs declaration is made
  ; [Am. 33]

| (14) | ‘destruction’ means the physical destruction, recycling or disposal of goods outside commercial channels, in such a way as to preclude injury to the holder of the decision granting the application; |
| --- | --- |

(14)

‘destruction’ means the physical destruction, recycling or disposal of goods outside commercial channels, in such a way as to preclude injury to the holder of the decision granting the application;

| (15) | ‘customs supervision’ means
  action taken in general by
  the supervision by customs authorities as referred to in Article 4(13) of Regulation (EEC) No 2913/92

  with a view to ensuring that customs legislation and, where appropriate, other provisions applicable to goods subject to such action are observed
  ; [Am. 34] |
| --- | --- |

(15)

‘customs supervision’ means
  action taken in general by
  the supervision by customs authorities as referred to in Article 4(13) of Regulation (EEC) No 2913/92

  with a view to ensuring that customs legislation and, where appropriate, other provisions applicable to goods subject to such action are observed
  ; [Am. 34]

| (16) | ‘customs territory of the Union’ means the customs territory of the Community as referred to in Article 3 of Regulation (EEC) No 2913/92; |
| --- | --- |

(16)

‘customs territory of the Union’ means the customs territory of the Community as referred to in Article 3 of Regulation (EEC) No 2913/92;

| (17) | ‘release of the goods’ means the act whereby the customs authorities make goods available for the purposes specified for the customs procedure under which they are placed; |
| --- | --- |

(17)

‘release of the goods’ means the act whereby the customs authorities make goods available for the purposes specified for the customs procedure under which they are placed;

| (17a) | ‘small consignment’ means a single package of commercial nature which:










  (a) | includes fewer than three items; or |
| --- | --- | --- |

(17a)

‘small consignment’ means a single package of commercial nature which:

(a)

includes fewer than three items; or

| (b) | includes items of a total weight of less than 2 kilograms; [Am. 35] |
| --- | --- |

(b)

includes items of a total weight of less than 2 kilograms; [Am. 35]

| (17b) | ‘perishable good’ means a good that is liable to significantly reduce in value over time or, because of its nature, is in danger of being destroyed. [Am. 36] |
| --- | --- |

(17b)

‘perishable good’ means a good that is liable to significantly reduce in value over time or, because of its nature, is in danger of being destroyed. [Am. 36]

Article 3

Applicable law

Without prejudice to Article 8 of Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) (23), the law of the Member State where the goods are found in one of the situations referred to in Article 1(1) shall apply for the purpose of determining whether the use of those goods gives rise to suspicion of infringement of an intellectual property right or has infringed an intellectual property right.

CHAPTER II

APPLICATIONS FOR ACTION BY THE CUSTOMS AUTHORITIES

Section 1

SUBMISSION OF APPLICATIONS FOR ACTION

Article 4

Persons entitled to submit an application

1.   The persons entitled to submit a national or a Union application shall be any of the following:

| (a) | holders of intellectual property rights; |
| --- | --- |

(a)

holders of intellectual property rights;

| (b) | intellectual property collective rights management bodies which are regularly recognised as having a right to represent

  lawfully representing
  holders of copyrights or related rights; [Am. 37] |
| --- | --- |

(b)

intellectual property collective rights management bodies which are regularly recognised as having a right to represent

  lawfully representing
  holders of copyrights or related rights; [Am. 37]

| (c) | professional defence bodies which are regularly recognised as having a right to represent

  lawfully representing
  holders of intellectual property rights; [Am. 38] |
| --- | --- |

(c)

professional defence bodies which are regularly recognised as having a right to represent

  lawfully representing
  holders of intellectual property rights; [Am. 38]

| (d) | groups within the meaning of Article 5(1) of Regulation (EC) No 510/2006, groups of producers in the meaning of Article 118e of Regulation (EC) No 1234/2007 or similar groups of producers provided for in the legislation of the Union governing geographical indications representing producers of a geographical indication or representatives of such groups; operators entitled to use a geographical indication; as well as inspection bodies competent for such a geographical indication. |
| --- | --- |

(d)

groups within the meaning of Article 5(1) of Regulation (EC) No 510/2006, groups of producers in the meaning of Article 118e of Regulation (EC) No 1234/2007 or similar groups of producers provided for in the legislation of the Union governing geographical indications representing producers of a geographical indication or representatives of such groups; operators entitled to use a geographical indication; as well as inspection bodies competent for such a geographical indication.

2.   In addition to the persons set out in paragraph 1, any of the following shall be entitled to submit a national application:

| (a) | all other persons authorised to use intellectual property rights; |
| --- | --- |

(a)

all other persons authorised to use intellectual property rights;

| (b) | groups of producers provided for in the legislation of the Member States governing geographical indications representing producers of a geographical indication or representatives of such groups, operators entitled to use a geographical indication, as well as inspection bodies competent for such a geographical indication. |
| --- | --- |

(b)

groups of producers provided for in the legislation of the Member States governing geographical indications representing producers of a geographical indication or representatives of such groups, operators entitled to use a geographical indication, as well as inspection bodies competent for such a geographical indication.

3.   In addition to the persons set out in paragraph 1, the holder of an exclusive license covering the customs territory of the Union shall be entitled to submit a Union application.

4.   All persons entitled to submit an application under paragraphs 1, 2 and 3 must be able to initiate proceedings for infringement of intellectual property rights in the Member State where the goods are found.

Article 5

Intellectual property rights covered by Union applications

A Union application may be submitted with respect to any intellectual property right applying throughout the Union.

Article 6

Submission of applications

1.   The persons referred to in Article 4 may request action by the customs authorities where the use of goods is suspected of infringing an intellectual property right by submitting an application to the competent customs department. The application shall be made out on the form referred to in paragraph 3.

1a.
     
  The persons referred to in Article 4 shall only submit one application for each intellectual property right protected in a Member State or in the Union. [Am. 39]

2.   Each Member State shall designate the customs department competent to receive and process applications. The Member State shall inform the Commission accordingly and the Commission shall make public the list of competent customs departments designated by the Member States.

3.   The Commission shall establish an application form by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2).
  When exercising its implementing power, the Commission shall consult the European Data Protection Supervisor. [Am. 40]

The form shall, in particular, require the following information to be provided by the applicant:

| (a) | details of the applicant; |
| --- | --- |

(a)

details of the applicant;

| (b) | status of the applicant within the meaning of Article 4; |
| --- | --- |

(b)

status of the applicant within the meaning of Article 4;

| (c) | supporting documents to be provided to satisfy the customs department that the applicant is a person entitled to submit the application; |
| --- | --- |

(c)

supporting documents to be provided to satisfy the customs department that the applicant is a person entitled to submit the application;

| (d) | the empowerment of natural or legal persons representing the applicant, in accordance with the legislation of the Member State in which the application is filed; |
| --- | --- |

(d)

the empowerment of natural or legal persons representing the applicant, in accordance with the legislation of the Member State in which the application is filed;

| (e) | the intellectual property right or rights to be enforced; |
| --- | --- |

(e)

the intellectual property right or rights to be enforced;

| (f) | in the case of a Union application, the Member State or Member States in which customs action is requested; |
| --- | --- |

(f)

in the case of a Union application, the Member State or Member States in which customs action is requested;

| (g) | specific and technical data on the authentic goods, including
  marking, such as bar-coding, and
  images where appropriate; [Am. 41] |
| --- | --- |

(g)

specific and technical data on the authentic goods, including
  marking, such as bar-coding, and
  images where appropriate; [Am. 41]

| (h) | the information, to be attached to the form, needed to enable the customs authorities to readily identify the goods in question; |
| --- | --- |

(h)

the information, to be attached to the form, needed to enable the customs authorities to readily identify the goods in question;

| (i) | any information relevant to the customs authorities' analysis and assessment of the risk of infringement of the intellectual property right(s) concerned
  , such as the authorised distributors
  ; [Am. 42] |
| --- | --- |

(i)

any information relevant to the customs authorities' analysis and assessment of the risk of infringement of the intellectual property right(s) concerned
  , such as the authorised distributors
  ; [Am. 42]

| (j) | name(s) and address(es) of the representative(s) of the applicant in charge of legal and technical matters; |
| --- | --- |

(j)

name(s) and address(es) of the representative(s) of the applicant in charge of legal and technical matters;

| (k) | undertaking by the applicant to notify the competent customs department of any of the situations laid down in Article 14; |
| --- | --- |

(k)

undertaking by the applicant to notify the competent customs department of any of the situations laid down in Article 14;

| (l) | undertaking by the applicant to forward and update any information relevant to the customs authorities' analysis and assessment of the risk of infringement of the intellectual property right(s) concerned; |
| --- | --- |

(l)

undertaking by the applicant to forward and update any information relevant to the customs authorities' analysis and assessment of the risk of infringement of the intellectual property right(s) concerned;

| (m) | undertaking by the applicant to assume liability under the conditions laid down in Article 26; |
| --- | --- |

(m)

undertaking by the applicant to assume liability under the conditions laid down in Article 26;

| (n) | undertaking by the applicant to bear the costs referred to in Article 27 under the conditions laid down in that Article; |
| --- | --- |

(n)

undertaking by the applicant to bear the costs referred to in Article 27 under the conditions laid down in that Article;

| (o) | undertaking by the applicant to agree that the data provided by him/her will be processed by the Commission;
  [Am. 43] |
| --- | --- |

(o)

undertaking by the applicant to agree that the data provided by him/her will be processed by the Commission;
  [Am. 43]

The application shall contain the information that must be provided to the data subject pursuant to Regulation (EC) No 45/2001 and the national laws implementing Directive 95/46/EC. [Am. 44]

4.   Where computerised systems are available for the purpose of receiving and processing applications, applications shall be submitted using electronic data-processing techniques.
  Member States shall make such systems available no later than 1 January 2014. [Am. 45]

5.   Where an application is submitted after notification by the customs authorities of the suspension of the release or detention of the goods in accordance with Article 17(4), that application shall comply with the following additional requirements:

| (a) | it shall be submitted to the competent customs department within four working days of the notification of the suspension of the release or detention of the goods; |
| --- | --- |

(a)

it shall be submitted to the competent customs department within four working days of the notification of the suspension of the release or detention of the goods;

| (b) | it shall be a national application; |
| --- | --- |

(b)

it shall be a national application;

| (c) | it shall contain the information required in paragraph 3. However, the applicant shall be allowed to omit the particulars mentioned in points (g) to (i) of paragraph 3. |
| --- | --- |

(c)

it shall contain the information required in paragraph 3. However, the applicant shall be allowed to omit the particulars mentioned in points (g) to (i) of paragraph 3.

Section 2

DECISIONS ON APPLICATIONS FOR ACTION

Article 7

Processing of applications

1.   Where, on receipt of an application, the competent customs department considers that it does not contain all the information required by Article 6(3), the competent customs department shall request the applicant to supply the missing information within 10 working days of dispatch of the notification.

In such cases, the time limit referred to in the first paragraph of Article 8 shall be suspended until the relevant information is received.

2.   Where the applicant does not provide the missing information within the period referred to in paragraph 1, the competent customs department shall

  may
  reject the application.
  In that event the competent customs department shall provide reasons for its decision and include information on the appeal procedure. [Am. 46]

3.   The applicant shall not be charged a fee to cover the administrative costs resulting from the processing of the application.

Article 8

Notification of decisions granting or rejecting applications for action

The competent customs department shall notify the applicant of its decision granting or rejecting the application within 30 working days of the receipt of the application.

However, where the applicant has been previously notified of the suspension of the release or detention of the goods by the customs authorities, the competent customs department shall notify the applicant of its decision granting or rejecting the application within one working day of the receipt of the application.

Article 9

Decisions concerning applications for action

1.   Decisions granting a national application, decisions revoking such decisions or amending them, and decisions extending the period during which customs authorities are to take action shall take effect in the Member State in which the national application was filed from the date of their adoption.

2.   Decisions granting a Union application, decisions revoking such decisions or amending them and decisions extending the period during which customs authorities are to take action shall take effect as follows:

| (a) | in the Member State in which the application was filed, from the date of adoption; |
| --- | --- |

(a)

in the Member State in which the application was filed, from the date of adoption;

| (b) | in all other Member States where action by the customs authorities is requested, from the date on which the customs authorities are notified in accordance with Article 13(2) and provided that the holder of the decision has fulfilled his obligations under Article 27(3). |
| --- | --- |

(b)

in all other Member States where action by the customs authorities is requested, from the date on which the customs authorities are notified in accordance with Article 13(2) and provided that the holder of the decision has fulfilled his obligations under Article 27(3).

Article 10

Period during which the customs authorities are to take action

1.   When granting an application, the competent customs department shall specify the period during which the customs authorities are to take action.

That period shall begin from the date of adoption of the decision granting the application and shall not exceed one year.

2.   Where an application submitted after notification by the customs authorities of the suspension of the release or detention of the goods in accordance with Article 17(4) does not contain the particulars referred to in points (g) to (i) of Article 6(3), it shall be granted only for the suspension of the release or detention of those goods.

3.   Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application, no action shall be taken by the customs authorities. The decision granting the application shall be revoked or amended accordingly by the customs authorities that granted the decision.

Article 11

Extension of the period during which the customs authorities are to take action

1.   On expiry of the period during which the customs authorities are to take action, and subject to the prior discharge by the holder of the decision of any debt owed to the customs authorities under this Regulation, the customs department which took the initial decision may, at the request of the holder of the decision granting the application, extend that period.

2.   Where the request for extension of the period during which the customs authorities are to take action is made less than 30 working days before the expiry of that decision, the competent customs department may refuse the extension.

3.   The request for extension of the period during which the customs authorities are to take action shall indicate any change in the information provided under Article 6(3).

4.   The competent customs department shall notify its decision on the extension to the holder of the decision granting the application within 30 working days of the receipt of that request.

5.   The extended period during which the customs authorities are to take action shall run from the date of adoption of the decision granting the extension and shall not exceed one year.

Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application, no action shall be taken by the customs authorities. The decision granting the extension shall be revoked or amended accordingly by the customs authorities that granted the decision.

6.   The holder of the decision shall not be charged a fee to cover the administrative costs resulting from the processing of the request for extension.

7.   The Commission shall establish an extension request form by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2).

Article 12

Amending the decision with regard to intellectual property rights

The competent customs department that adopted the decision granting the application may, at the request of the holder of that decision, modify the list of intellectual property rights in that decision.

In the case of a decision granting a Union application, any modification consisting in adding intellectual property rights shall be limited to those intellectual property rights covered by Article 5.

Article 13

Notification obligations of the competent customs department

1.   The competent customs department to which a national application has been submitted shall forward the following decisions to the customs offices of its Member State, immediately after their adoption:

| (a) | its decisions granting a national application; |
| --- | --- |

(a)

its decisions granting a national application;

| (b) | its decisions revoking decisions granting a national application; |
| --- | --- |

(b)

its decisions revoking decisions granting a national application;

| (c) | its decisions amending decisions granting a national application; |
| --- | --- |

(c)

its decisions amending decisions granting a national application;

| (d) | its decisions extending the period during which the customs authorities are to take action. |
| --- | --- |

(d)

its decisions extending the period during which the customs authorities are to take action.

2.   The competent customs department to which a Union application has been submitted shall forward the following decisions to the competent customs department of the Member State or Member States indicated in the Union application:

| (a) | decisions granting a Union application; |
| --- | --- |

(a)

decisions granting a Union application;

| (b) | decisions revoking decisions granting a Union application; |
| --- | --- |

(b)

decisions revoking decisions granting a Union application;

| (c) | decisions amending decisions granting a Union application; |
| --- | --- |

(c)

decisions amending decisions granting a Union application;

| (d) | decisions extending or refusing to extend the period during which the customs authorities are to take action; |
| --- | --- |

(d)

decisions extending or refusing to extend the period during which the customs authorities are to take action;

| (e) | decisions suspending the actions of the customs authorities under Article 15(2). |
| --- | --- |

(e)

decisions suspending the actions of the customs authorities under Article 15(2).

The competent customs department of the Member State(s) indicated in the Union application shall thereafter immediately forward those decisions to their customs offices.

3.   Once the central database of the Commission referred to in Article 31(3) is in place, all exchanges of data on decisions concerning applications for action, accompanying documents and notifications between the customs authorities of the Member States shall be made via that database.

Article 14

Notification obligations of the holder of the decision granting the application

The holder of the decision granting the application shall notify
  within five working days
  the competent customs department that adopted that decision of any of the following: [Am. 47]

| (a) | an intellectual property right covered by his or her application ceases to have effect; |
| --- | --- |

(a)

an intellectual property right covered by his or her application ceases to have effect;

| (b) | the holder of the decision ceases for other reasons to be the person entitled to submit the application; |
| --- | --- |

(b)

the holder of the decision ceases for other reasons to be the person entitled to submit the application;

| (c) | modifications to the information required under Article 6(3). |
| --- | --- |

(c)

modifications to the information required under Article 6(3).

Article 15

Failure of the holder of the decision granting the application to fulfil his/her obligations

1.   Where the holder of the decision granting the application uses the information provided by the customs authorities for purposes other than those provided for in Article 19, the competent customs department may:

| (a) | suspend the decision granting the application in the Member State where the information was provided or used until the expiry of the period during which the customs authorities are to take action; |
| --- | --- |

(a)

suspend the decision granting the application in the Member State where the information was provided or used until the expiry of the period during which the customs authorities are to take action;

| (b) | refuse to extend the period during which the customs authorities are to take action. |
| --- | --- |

(b)

refuse to extend the period during which the customs authorities are to take action.

2.   The competent customs department may decide to suspend the actions of the customs authorities until the expiry of the period during which those authorities are to take action, where the holder of the decision:

| (a) | does not fulfil his/her notification obligations under Article 14; |
| --- | --- |

(a)

does not fulfil his/her notification obligations under Article 14;

| (b) | does not comply with the requirements of Article 18(2) on returning samples;
  [Am. 48] |
| --- | --- |

(b)

does not comply with the requirements of Article 18(2) on returning samples;
  [Am. 48]

| (c) | does not fulfil his/her obligations under Article 27(1) and (3) with respect to costs and translation; |
| --- | --- |

(c)

does not fulfil his/her obligations under Article 27(1) and (3) with respect to costs and translation;

| (d) | does not initiate proceedings as provided for in Articles 20(1), 23(4)

  Article 20(4)
  or
  Article
  24(9). [Am. 49] |
| --- | --- |

(d)

does not initiate proceedings as provided for in Articles 20(1), 23(4)

  Article 20(4)
  or
  Article
  24(9). [Am. 49]

In the case of a Union application, the decision to suspend the actions of the customs authorities shall have effect only in the Member State where such decision is taken.

CHAPTER III

PROVISIONS GOVERNING ACTION BY THE CUSTOMS AUTHORITIES

Section 1

SUSPENSION OF THE RELEASE OR DETENTION OF GOODS SUSPECTED OF INFRINGING AN INTELLECTUAL PROPERTY RIGHT

Article 16

Suspension of the release or detention of the goods following the grant of an application

1.   Where the customs authorities of a Member State identify, in one of the situations referred to in Article 1(1), goods suspected of infringing an intellectual property right covered by a decision granting an application for action, they shall take a decision to suspend the release of the goods or to detain them. [Am. 50]

2.   Before adopting

  suspending
  the decision of suspension of release of or detention of

  detaining
  the goods, the customs authorities may ask the holder of the decision granting the application to provide them with any relevant information. The customs authorities may

  shall
  also provide the holder of the decision
  , at his or her request,
  with information about the actual or supposed number of items, their nature and images

  photographs
  of those items as appropriate. [Am. 51]

3.   Before adopting the decision of suspension of release

  Where goods suspected of infringing intellectual property rights are not counterfeit
  or detention of the

  pirated
  goods, the customs authorities shall communicate their intention to the declarant or, in cases where goods are to be detained, the holder of the goods
  before suspending the release of or detaining the goods
  . The declarant or the holder of the goods shall be given the opportunity to express his/her views within three working days of dispatch

  receipt
  of that communication. [Am. 52]

3a.
     
  Where goods suspected to be an imitation or a copy of a product protected in the Union by an intellectual property right are placed under a suspensive procedure, the customs authorities shall request the declarant or holder of the goods to provide adequate evidence that the final destination of the goods is beyond the territory of the Union within three working days of receipt of that request. Where no adequate evidence to the contrary is provided, customs authorities shall presume the final destination to be the territory of the Union.

By ... (24) the Commission shall adopt implementing acts establishing guidelines for customs authorities to assess the risk of deviation of the goods referred to in the first subparagraph onto the market of the Union. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2). [Am. 53]

4.   The customs authorities shall notify the holder of the decision granting the application and the declarant or holder of the goods of their decision to suspend

  the suspension of
  the release of the goods or to detain them

  their detention
  within one working day
  . Alternatively, the customs authorities may request the holder
  of the adoption

  decision granting the application to notify the declarant or holder
  of their

  the goods accordingly, where the holder of the
  decision
  granting the application guarantees that he or she will comply with the time limits and obligations laid down in this Regulation
  . [Am. 54]

The notification to the declarant or holder of the goods shall include information on the legal consequences provided for in Article 20 with respect to other goods than counterfeit and pirated goods and by Article 23 with respect to counterfeit and pirated goods. [Am. 55]

5.   The customs authorities shall inform the holder of the decision granting the application and the declarant or holder of the goods of the actual or estimated quantity, the actual or presumed nature of the goods, including images

  photographs
  of those items as appropriate, whose release has been suspended or which have been detained. [Am. 56]

6.   Where several persons are considered to be holder of the goods, the customs authorities shall not be obliged to inform more than one person.

Article 17

Suspension of the release or detention of the goods without the grant of an application

1.   Where the customs authorities identify, in the course of action in one of the situations referred to in Article 1(1), goods suspected of infringing an intellectual property right, they may suspend the release of those goods or detain them before having been notified of a decision granting an application with respect to those goods.

2.   Before adopting

  suspending
  the decision of suspension of release
  of
  or detention of

  detaining
  the goods, the customs authorities may, without disclosing any information other than the actual or supposed number of items, their nature and images

  photographs
  of those items as appropriate, request any person entitled to submit an application concerning the alleged infringement of intellectual property rights to provide them with any relevant information. [Am. 57]

3.   Before adopting a decision to suspend the release of the goods or to detain them, the customs authorities shall communicate their intention to the declarant or, in cases where goods are to be detained, to the holder of the goods. The declarant or the holder of the goods shall be given the opportunity to express his/her views within three working days of dispatch of that communication.
  [Am. 58]

3a.
     
  Where goods suspected to be an imitation or a copy of a product protected in the Union by an intellectual property right are placed under a suspensive procedure, the customs authorities shall request the declarant or holder of the goods to provide adequate evidence that the final destination of the goods is beyond the territory of the Union within three working days of dispatch of that request. Where no adequate evidence to the contrary is provided, customs authorities shall presume the final destination to be the territory of the Union.

By ... (25) the Commission shall adopt implementing acts establishing guidelines for customs authorities to assess the risk of deviation of the goods referred to in the first subparagraph onto the market of the Union. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2). [Am. 59]

4.   The customs authorities shall notify the suspension of the release or the detention of the goods to any person entitled to submit an application concerning the alleged infringement of intellectual property rights within one working day of the suspension of the release or of the detention of the goods.

4a.
     
  Where no person entitled to submit an application can be identified, customs authorities shall cooperate with the competent authorities in order to identify a person entitled to submit an application. [Am. 60]

5.   The customs authorities shall grant the release of the goods or put an end to their detention immediately after completion of all customs formalities in the following cases:

| (a) | where they have not identified any person entitled to submit an application concerning the alleged infringement of intellectual property rights within one working day from the suspension of the release or the detention of the goods; |
| --- | --- |

(a)

where they have not identified any person entitled to submit an application concerning the alleged infringement of intellectual property rights within one working day from the suspension of the release or the detention of the goods;

| (b) | where they have not received or have rejected an application in accordance with Article 6(5). |
| --- | --- |

(b)

where they have not received or have rejected an application in accordance with Article 6(5).

The customs authorities shall notify the declarant or holder of the goods of their decision to suspend

  the suspension of
  the release of the goods or to detain them

  their detention
  within one working dayof the adoption of their decision. [Am. 61]

6.   This Article shall not apply to perishable goods.
  [Am. 62]

Article 18

Inspection and sampling of goods whose release has been suspended or which have been detained

1.   The customs authorities shall give the holder of the decision granting the application and the declarant or holder of the goods the opportunity to inspect the goods whose release has been suspended or which have been detained.

2.   The customs authorities may take samples
  representative of the goods as a whole
  and may provide
  or send such
  samples to the holder of the decision granting the application, at his/her request, strictly for the purposes of analysis and to facilitate the subsequent procedure in relation to counterfeit and pirated goods. Any analysis of those samples shall be carried out under the sole responsibility of the holder of the decision granting the application. [Am. 63]

Where circumstances allow, the samples shall be returned on completion of the technical analysis and before the goods are released or their detention is ended.

3.   The customs authorities shall, upon request and if known, provide the holder of the decision granting the application
  and, where relevant, law enforcement authorities and agencies
  with the names and addresses of the consignee, the consignor, the declarant or the holder of the goods, the customs procedure and the origin, provenance and destination of goods suspected of infringing an intellectual property right. [Am. 64]

4.   The conditions of storage of the goods during the period of suspension of release or detention, including provisions regarding the costs, shall be determined by each Member State.

Article 19

Permitted use of certain information by the holder of the decision granting the application

Where the holder of the decision granting the application has received the information referred to in Article 18(3), the holder may only use that information for the following purposes:

| (a) | to initiate proceedings to determine whether an intellectual property right has been infringed
  , or in the course of such proceedings
  ; [Am. 65] |
| --- | --- |

(a)

to initiate proceedings to determine whether an intellectual property right has been infringed
  , or in the course of such proceedings
  ; [Am. 65]

| (aa) | to take further action in order to identify the infringer of the intellectual property right; [Am. 66] |
| --- | --- |

(aa)

to take further action in order to identify the infringer of the intellectual property right; [Am. 66]

| (ab) | to initiate criminal proceedings or in the course of such proceedings; [Am. 67] |
| --- | --- |

(ab)

to initiate criminal proceedings or in the course of such proceedings; [Am. 67]

| (b) | to seek compensation from the infringer or other persons where goods are destroyed in accordance with Articles

  Article
  20(3) or 23(3); [Am. 68] |
| --- | --- |

(b)

to seek compensation from the infringer or other persons where goods are destroyed in accordance with Articles

  Article
  20(3) or 23(3); [Am. 68]

| (ba) | for or in connection with a criminal investigation or criminal proceedings, including information related to an intellectual property right; [Am. 69] |
| --- | --- |

(ba)

for or in connection with a criminal investigation or criminal proceedings, including information related to an intellectual property right; [Am. 69]

| (bb) | in settlement negotiations out of court. [Am. 70] |
| --- | --- |

(bb)

in settlement negotiations out of court. [Am. 70]

Article 19a

Sharing of information and data between customs authorities

Subject to appropriate data protection safeguards, the Commission may decide that information and data collected under Article 18(3) is to be shared between customs authorities in the Union and relevant authorities in third countries and establish the conditions of such sharing. [Am. 71]

Section 2

DESTRUCTION OF GOODS,
  INITIATION OF PROCEEDINGS AND ANTICIPATED RELEASE OF GOODS [Am. 72]

Article 20

Destruction of goods and
  initiation of proceedings [Am. 73]

1.   Where goods other than those covered by Articles 23 and 24 are suspected of infringing

  Goods the release of which has been suspended or which have been detained in accordance with Article 16 may be destroyed under customs control, without there being any need to determine whether
  an intellectual property right,

  has been infringed under the law of the Member State where the goods are found
  ,
  where all of the following conditions are fulfilled:

| (a) | the holder of the decision granting the application shall initiate proceedings to determine whether

  has, based on the information provided
  to
  him or her in accordance with Article 16(2), confirmed in writing to the customs authorities that
  an intellectual property right has been infringed
  , indicating which intellectual right has been infringed,
  within 10 working days of dispatch of the decision to suspend

  , or within three working days in the case of perishable goods, of the receipt of the notification of the suspension of
  the release of the goods or to detain them

  their detention; |
| --- | --- |

(a)

the holder of the decision granting the application shall initiate proceedings to determine whether

  has, based on the information provided
  to
  him or her in accordance with Article 16(2), confirmed in writing to the customs authorities that
  an intellectual property right has been infringed
  , indicating which intellectual right has been infringed,
  within 10 working days of dispatch of the decision to suspend

  , or within three working days in the case of perishable goods, of the receipt of the notification of the suspension of
  the release of the goods or to detain them

  their detention;

| (b) | the holder of the decision granting the application has confirmed in writing to the customs authorities his or her agreement to the destruction of the goods within 10 working days, or within three working days in the case of perishable goods, of the receipt of the notification of the suspension of the release of the goods or their detention; |
| --- | --- |

(b)

the holder of the decision granting the application has confirmed in writing to the customs authorities his or her agreement to the destruction of the goods within 10 working days, or within three working days in the case of perishable goods, of the receipt of the notification of the suspension of the release of the goods or their detention;

| (c) | the declarant or holder of the goods has confirmed in writing to the customs authorities his/her agreement to the destruction of the goods within 10 working days, or within three working days in the case of perishable goods, of the receipt of the notification of the suspension of the release of the goods or their detention
  . |
| --- | --- |

(c)

the declarant or holder of the goods has confirmed in writing to the customs authorities his/her agreement to the destruction of the goods within 10 working days, or within three working days in the case of perishable goods, of the receipt of the notification of the suspension of the release of the goods or their detention
  .

In the case of perishable goods suspected of infringing an intellectual property right, the period for initiating the proceedings referred to in the first subparagraph shall be three working days of dispatch of the decision to suspend the release of the goods or to detain them.
  [Am. 74]

2.   
  Where the declarant or holder of the goods within the periods set out in point (c) of paragraph 1 has not confirmed his or her agreement to destruction nor notified his or her opposition to destruction to
  the customs authorities shall grant

  that adopted the decision to suspend
  the release of the goods or put an end to their detention immediately after completion of all

  to detain them, the
  customs formalities where they have not been informed by the

  authorities shall deem that the declarant or
  holder of the decision granting the application, within the period referred to in paragraph 1, of any of the following:

| (a) | the initiation of proceedings to determine whether an intellectual property right has been infringed; |
| --- | --- |

(a)

the initiation of proceedings to determine whether an intellectual property right has been infringed;

| (b) | a written agreement between the holder of the decision granting the application and the holder of the goods to abandon the goods for destruction

  goods has agreed to their destruction
  . [Am. 75] |
| --- | --- |

(b)

a written agreement between the holder of the decision granting the application and the holder of the goods to abandon the goods for destruction

  goods has agreed to their destruction
  . [Am. 75]

3.   In the case of an agreement to abandon the goods for destruction referred to in paragraph 2(b), The destruction shall be carried out under customs control at the expense and under the responsibility of the holder of the decision granting the application, unless otherwise specified in the legislation of the Member State where the goods are destroyed.
  Samples may be taken prior to destruction. [Am. 76]

4.   The customs authorities may extend the period referred to in the first subparagraph of paragraph 1 by a maximum of 10 working days upon request by

  Where there is no agreement to destruction or the declarant or the holder of the goods objects to destruction,
  the holder of the decision granting the application in appropriate cases.

  shall initiate proceedings to determine whether an intellectual property right has been infringed within 20 working days, or three working days in the case of perishable goods, of the receipt of the notification of the suspension of the release of the goods or their detention
  .

In the case of perishable goods, the period referred to in the second subparagraph of paragraph 1 shall not be extended.
  [Am. 77]

4a.
     
  The customs authorities shall grant the release of the goods or put an end to their detention, as appropriate, immediately after completion of all customs formalities, where they have not received information from the holder of the decision granting the application on any of the following:

| (a) | his or her agreement to the destruction within the periods referred to in point (b) of paragraph 1; |
| --- | --- |

(a)

his or her agreement to the destruction within the periods referred to in point (b) of paragraph 1;

| (b) | the initiation of proceedings to determine whether an intellectual property right has been infringed within the period referred to in paragraph 4. [Am. 78] |
| --- | --- |

(b)

the initiation of proceedings to determine whether an intellectual property right has been infringed within the period referred to in paragraph 4. [Am. 78]

Article 21

Anticipated release of goods

1.   Where the customs authorities have been notified of the initiation of proceedings to determine whether a design, patent, utility model or plant variety right has been infringed and the period provided for in Article 20 has expired, the declarant or holder of the goods may request the customs authorities to release the goods or put an end to their detention.

The customs authorities shall release the goods or put an end to their detention only where all the following conditions are fulfilled:

| (a) | the declarant or holder of the goods has provided a security; |
| --- | --- |

(a)

the declarant or holder of the goods has provided a security;

| (b) | the authority competent for determining whether an intellectual property right has been infringed has not authorised precautionary measures; |
| --- | --- |

(b)

the authority competent for determining whether an intellectual property right has been infringed has not authorised precautionary measures;

| (c) | all customs formalities have been completed. |
| --- | --- |

(c)

all customs formalities have been completed.

2.   The security referred to in point (a) of paragraph 1 shall be provided by the declarant or holder of the goods within 10 working days following the date on which the customs authorities receive the request referred to in paragraph 1.

3.   The customs authorities shall set the security at an amount sufficiently high to protect the interests of the holder of the decision granting the application.

4.   The provision of the security shall not affect the other legal remedies available to the holder of the decision granting the application.

Article 22

Prohibited customs-approved treatment and use of goods abandoned for destruction

1.   Goods abandoned for destruction under
  Article 20



  ,
  23

  or Article 24
  shall not be: [Am. 79]

| (a) | released for free circulation; |
| --- | --- |

(a)

released for free circulation;

| (b) | brought out of the customs territory of the Union; |
| --- | --- |

(b)

brought out of the customs territory of the Union;

| (c) | exported; |
| --- | --- |

(c)

exported;

| (d) | re-exported; |
| --- | --- |

(d)

re-exported;

| (e) | placed under a suspensive procedure; |
| --- | --- |

(e)

placed under a suspensive procedure;

| (f) | placed in a free zone or free warehouse. |
| --- | --- |

(f)

placed in a free zone or free warehouse.

1a.
     
  By way of exception to the provisions of paragraph 1, the customs authorities may authorise the public or private organisations, which aim at combating against counterfeiting and have been individually authorised prior to these operations, to the measures listed in points (a) to (f) of paragraph 1. Prior to the destruction of the abandoned goods, the authorised organisations may stock them, in the conditions defined in the authorisation, for the purposes of analysis and establishment of a database of information intended to fight against counterfeiting. The authorised organisations shall be published on the website of the Commission. [Am. 80]

2.   The customs authorities may allow the goods referred to in paragraph 1 to be moved under customs supervision between different places within the customs territory of the Union with a view to their destruction under customs control
  or their use for education and exhibition purposes accompanied by appropriate security measures
  . [Am. 81]

Section 3

COUNTERFEIT AND PIRATED GOODS
  [Am. 82]

Article 23

Destruction and initiation of proceedings

1.   Goods suspected of being counterfeit goods or pirated goods may be destroyed under customs control, without there being any need to determine whether an intellectual property right has been infringed under the law of the Member State where the goods are found, where all of the following conditions are fulfilled:

| (a) | the holder of the decision granting the application has informed the customs authorities in writing of his/her agreement to the destruction of the goods within 10 working days, or three working days in the case of perishable goods, of dispatch of the decision to suspend the release of the goods or to detain them; |
| --- | --- |

(a)

the holder of the decision granting the application has informed the customs authorities in writing of his/her agreement to the destruction of the goods within 10 working days, or three working days in the case of perishable goods, of dispatch of the decision to suspend the release of the goods or to detain them;

| (b) | the declarant or holder of the goods has confirmed in writing to the customs authorities his/her agreement to the destruction of the goods within 10 working days, or three working days in the case of perishable goods, of dispatch of the decision to suspend the release of the goods or to detain them. |
| --- | --- |

(b)

the declarant or holder of the goods has confirmed in writing to the customs authorities his/her agreement to the destruction of the goods within 10 working days, or three working days in the case of perishable goods, of dispatch of the decision to suspend the release of the goods or to detain them.

2.   Where the declarant or holder of the goods has not confirmed his/her agreement to destruction within the periods set out in paragraph 1(b) nor notified his/her opposition to destruction to the customs authorities that adopted the decision to suspend the release of the goods or to detain them, the customs authorities may deem that the declarant or holder of the goods has agreed to their destruction.

The customs authorities shall inform the holder of the decision granting the application accordingly.

Where the declarant or holder of the goods objects to the destruction of the goods, the customs authorities shall inform the holder of the decision granting the application of such objection.

3.   The destruction shall be carried out under customs control, at the expense and under the responsibility of the holder of the decision granting the application, unless otherwise specified in the legislation of the Member State where the goods are destroyed. Samples may be taken prior to destruction.

4.   Where there is no agreement to destruction, the holder of the decision granting the application shall initiate proceedings to determine whether an intellectual property right has been infringed within 10 working days, or three working days in the case of perishable goods, of dispatch of the decision to suspend the release of the goods or to detain them.

The customs authorities may extend the periods referred to in the first subparagraph by a maximum of 10 working days upon request by the holder of the decision granting the application in appropriate cases.

In the case of perishable goods those periods shall not be extended.

5.   The customs authorities shall grant the release of the goods or put an end to their detention, as appropriate, immediately after completion of all customs formalities, where they have not received information from the holder of the decision granting the application on any of the following:

| (a) | his/her agreement to the destruction within the periods referred to in paragraph 1(a); |
| --- | --- |

(a)

his/her agreement to the destruction within the periods referred to in paragraph 1(a);

| (b) | the initiation of proceedings to determine whether an intellectual property right has been infringed within the period referred to in paragraph 4.
  [Am. 83] |
| --- | --- |

(b)

the initiation of proceedings to determine whether an intellectual property right has been infringed within the period referred to in paragraph 4.
  [Am. 83]

Article 24

Specific procedure for the destruction of goods in small consignments

1.   This Article applies to goods where all of the following conditions are fulfilled:

| (a) | goods are suspected of being counterfeit or pirated goods

  infringing an intellectual property right
  ; [Am. 84] |
| --- | --- |

(a)

goods are suspected of being counterfeit or pirated goods

  infringing an intellectual property right
  ; [Am. 84]

| (b) | goods are not perishable goods; |
| --- | --- |

(b)

goods are not perishable goods;

| (c) | goods are covered by a decision granting an application; |
| --- | --- |

(c)

goods are covered by a decision granting an application;

| (ca) | the holder of the decision granting the application has requested the use of the specific procedure in his application; [Am. 85] |
| --- | --- |

(ca)

the holder of the decision granting the application has requested the use of the specific procedure in his application; [Am. 85]

| (d) | goods are transported in small consignments. |
| --- | --- |

(d)

goods are transported in small consignments.

2.   Article 16 (3), (4) and (5) and Article 18(2) shall not apply. [Am. 86]

3.   When notifying, within one working day after its adoption, the decision to suspend the release of the goods or to detain them, the customs authorities shall inform the declarant or holder of the goods of the following:

| (a) | the customs authorities' intention to destroy the goods; |
| --- | --- |

(a)

the customs authorities' intention to destroy the goods;

| (b) | the rights of the declarant or holder of the goods under paragraphs 4 and 5. |
| --- | --- |

(b)

the rights of the declarant or holder of the goods under paragraphs 4 and 5.

4.   The declarant or holder of the goods shall be given the opportunity to express his/her point of view within 20

  five
  working days of dispatch

  receipt
  of the decision to suspend the release of the goods or to detain them. [Am. 87]

5.   The goods concerned may be destroyed where, within 20 working days of dispatch of the decision to suspend the release of the goods or to detain them, the declarant or holder of the goods has confirmed
  in writing
  to the customs authorities his/her agreement to the destruction of the goods.
  Such destruction shall be carried out under customs control at the expense of the holder of the decision granting the application. [Am. 88]

6.   Where the declarant or holder of the goods has not confirmed his or her agreement to destruction within the period referred to in paragraph 5, nor notified his or her opposition to destruction to the customs office that adopted the decision to suspend the release of the goods or to detain them, the customs authorities may deem that the declarant or holder of the goods has agreed to their destruction.

7.   The destruction shall be carried out under customs control and at the expense of the customs authorities.
  [Am. 89]

7a.
     
  The customs authorities shall provide the holder of the decision granting the application with access to information about the actual or presumed number of destroyed items and their nature where appropriate. [Am. 90]

8.   Where the declarant or holder of the goods objects to the destruction

  within 10 working days of receipt of the decision to suspend the release
  of the goods
  or to detain them has not confirmed his or her agreement to destruction or notified his or her opposition to destruction
  , the customs authorities shall inform the holder of the decision granting the application of such
  missing agreement or
  objection and of the number of items and their nature, including images of those items
  or samples
  where appropriate. [Am. 91]

9.   The customs authorities shall grant the release of the goods or put an end to their detention, as appropriate, immediately after completion of all customs formalities where they have not received information from the holder of the decision granting the application on the initiation of proceedings to determine whether an intellectual property right has been infringed within 10 working days of dispatch of the information referred to in paragraph 8.

10.   The Commission shall be empowered to adopt delegated acts in accordance with Article 30 concerning the thresholds that define small consignments for the purpose of this Article.
  [Am. 92]

CHAPTER IV

LIABILITY, COSTS AND PENALTIES

Article 25

Liability of the customs authorities

Without prejudice to the applicable legislation of the Member States, the decision granting an application shall not entitle the holder of that decision to compensation in the event that goods suspected of infringing an intellectual property right are not detected by a customs office and are released, or no action is taken to detain them.

Article 26

Liability of the holder of the decision granting the application

Where a procedure duly initiated pursuant to this Regulation is discontinued owing to an act or omission on the part of the holder of the decision granting the application or where the goods in question are subsequently found not to infringe an intellectual property right, the holder of the decision granting the application shall be liable towards the persons involved in a situation referred to in Article 1(1) in accordance with the legislation of the Member State where the goods were found.

Article 27

Costs

1.   Where requested by the customs authorities, the holder of the decision granting the application shall reimburse all costs incurred by the customs administration in keeping goods under customs supervision in accordance with Articles 16 and 17 and in destroying goods in accordance with
  Articles 20 and

  23

  24
  .
  The holder of a decision shall, upon request, be given information by the customs authorities on where and how the detained goods are being stored and on the costs associated with such storage, and shall be given the opportunity to comment on that storage
  . [Am. 93]

2.   This Article shall be without prejudice to the right of the holder of the decision granting the application to seek compensation from the infringer or other persons in accordance with the legislation of the Member State where the goods were found.

2a.
     
  Where the infringer cannot be identified, is not tangible or unable to provide compensation, the holder of the decision granting the application may seek compensation from the owner of the goods or the person who has a similar right of disposal over them. [Am. 94]

2b.
     
  Paragraph 2a shall not apply to the procedure set out in Article 24. [Am. 95]

3.   The holder of a decision granting a Union application shall provide and pay for any translation required by the customs authorities which are to take action concerning the goods suspected of infringing an intellectual property right.

Article 28

Administrative sanctions

Without prejudice to national law,
  the Member States shall lay down

  apply
  the rules on administrative sanctions applicable

  relating
  to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The administrative sanctions provided for must be effective, proportionate and dissuasive. [Am. 96]

The Member States shall notify those provisions to the Commission within six months from the date of entry into force of this Regulation and shall notify it without delay of any subsequent amendment affecting them.

CHAPTER V

COMMITTEE, DELEGATION AND FINAL PROVISIONS [Am. 97]

Article 29

Committee procedure

1.   The Commission shall be assisted by the Customs Code Committee established by Articles 247a and 248a of Regulation (EEC) No 2913/92. That committee is a committee within the meaning of Regulation (EU) No 182/2011.

2.   Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Article 30

Exercise of the delegation

1.   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 24(10) shall be conferred for an indeterminate period of time from the date of entry into force of this Regulation.

3.   The delegation of powers referred to in Article 24(10) 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 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.

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 24(10) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 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 2 months on the initiative of the European Parliament or the Council.
  [Am. 98]

Article 31

Exchange of data on decisions relating to application for action between the Member States and the Commission

1.   The competent customs departments shall notify the Commission of
  the necessary information relating to
  the following:

| (a) | decisions granting applications, including
  applications for action, including

  and
  any photograph(s), image(s) or brochure(s); |
| --- | --- |

(a)

decisions granting applications, including
  applications for action, including

  and
  any photograph(s), image(s) or brochure(s);

| (b) | decisions granting applications; |
| --- | --- |

(b)

decisions granting applications;

| (c) | any decisions extending the period during which the customs authorities are to take action or decisions revoking the decision granting the application or amending it; |
| --- | --- |

(c)

any decisions extending the period during which the customs authorities are to take action or decisions revoking the decision granting the application or amending it;

| (d) | any suspension of a decision granting the application. [Am. 99] |
| --- | --- |

(d)

any suspension of a decision granting the application. [Am. 99]

2.   Without prejudice to the provisions of point (g) of Article 24 of Regulation (EC) No 515/97, where the release of the goods is suspended or the goods are detained, the customs authorities shall transmit to the Commission any relevant information, including details on the goods, intellectual property right, procedures and transport.

3.   All information referred to in paragraphs 1 and 2 shall be stored in a central database of the Commission.
  Once the central database of the Commission is in place, the transmission of the information referred to in paragraphs 1 and 2 shall be made via that database. [Am. 100]

4.   The Commission shall make the relevant information referred to in paragraphs 1 and 2 available to the customs authorities of the Member States in an electronic form
  as soon as possible and not later than 1 January 2015
  .

4a.
     
  For the purposes of ensuring processing of the information referred to in paragraphs 1 and 2, the central database referred to in paragraph 3 shall be established in an electronic form. The central database shall contain the information, including personal data, referred to in the second subparagraph of Article 6(3), Article 13 and paragraphs 1 and 2 of this Article.

4b.
     
  The customs authorities of the Member States and the Commission shall have access to the information contained in the central database.

4c.
     
  The customs authority shall introduce into the central database information related to the applications submitted to the competent customs department. The customs authority which has introduced information into the central database shall, where necessary, amend, supplement, correct or delete such information. Each customs authority that has introduced information in the central database shall be responsible for the accuracy, adequacy and relevance of that information.

4d.
     
  The Commission shall establish and maintain adequate technical and organisational arrangements for the reliable and secure operation of the central database. The customs authority of each Member State shall establish and maintain adequate technical and organisational arrangements to ensure the confidentiality and security of processing with respect to the processing operations carried out by their customs authorities and with respect to terminals of the central database located on the territory of that Member State.

4e.
     
  The processing of personal data in the central database shall be carried out in compliance with Article 32. [Am. 101]

Article 32

Data protection provisions

1.   The processing of personal data in the central database of the Commission shall be carried out in accordance with Regulation (EC) No 45/2001 and under the supervision of the European Data Protection Supervisor.
  In any event, the implementing measures to be adopted should specify in detail the functional and technical characteristics of the database. [Am. 102]

2.   Processing of personal data by the competent authorities in the Member States shall be carried out in accordance with Directive 95/46/EC and under the supervision of the public independent authority of the Member State referred to in Article 28 of that Directive.

2a.
     
  Personal data shall be collected and used solely for the purposes of this Regulation. Personal data so collected shall be accurate and shall be kept up to date.

2b.
     
  Each customs authority that has introduced personal data into the central database shall be the controller with respect to the processing of those data.

2c.
     
  A data subject shall have a right of access to the personal data relating to him or her that are processed through the central database and, where appropriate, the right to the rectification, erasure or blocking of personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC.

2d.
     
  All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the competent customs department. Where a data subject has submitted a request for the exercise of the right of access, rectification, erasure or blocking to another office of customs authorities or to an office of the Commission, the office which received the request shall forward such request to the competent customs department.

2e.
     
  Personal data shall not be kept longer than six months from the date the relevant decision granting the application has been revoked or the relevant period during which the customs authorities are to take action has expired.

2f.
     
  Where the holder of the decision granting the application has initiated proceedings in accordance with Article 20(1) or Article 24(9) and has notified the competent customs department of the initiation of such proceedings, personal data shall be kept for six months after proceedings have determined in a final way whether an intellectual property right has been infringed. [Am. 103]

Article 33

Periods, dates and time limits

The rules applicable to periods, dates and time limits set out in Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (26) shall apply.

Article 34

Mutual administrative assistance

The provisions of Regulation (EC) No 515/97 shall apply.

Article 35

Repeal

Regulation (EC) No 1383/2003 is repealed with effect from ... (27)

References to the repealed Regulation shall be construed as references to this Regulation.

Article 36

Transitional provisions

Applications for action granted in accordance with Regulation (EC) No 1383/2003 shall remain valid for the period specified in the decision granting the application during which the customs authorities are to take action and shall not be extended.

Article 37

Entry into force and application

  reporting [Am. 104]

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

However, Article 24(1) to (9) shall apply from XX.XX.20XX.
  [Am. 106]

By ... (28) the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Regulation, as well as an analysis of this Regulation's impact on the availability of generic medicines, in the Union as well as globally. If necessary, that report shall be accompanied by appropriate proposals and/or recommendations. [Am. 121, 151 and 163]

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...,

For the European Parliament

The President

For the Council

The President

---

(1)  OJ C 363, 13.12.2011, p. 1.

1

(2)  Position of the European Parliament of 3 July 2012.

2

(3)  OJ C 253, 4.10.2008, p. 1.

3

(4)  OJ L 196, 2.8.2003, p. 7.

4

(5)  OJ L 302, 19.10.1992, p. 1.

5

(6)  OJ L 12, 16.1.2001, p. 1.

6

(7)  OJ C 45 E, 23.2.2010, p. 47.

7

(8)  

  OJ L 174, 1.7.2011, p. 74.

8

OJ L 174, 1.7.2011, p. 74.

(9)  
  Date: 24 months after the date of entry into force of this Regulation.

9

Date: 24 months after the date of entry into force of this Regulation.

(10)  OJ L 82, 22.3.1997, p. 1.

10

(11)  OJ L 281, 23.11.1995, p. 31.

11

(12)  OJ L 8, 12.1.2001, p. 1.

12

(13)  OJ L 55, 28.2.2011, p. 13.

13

(14)  OJ L 152, 16.6.2009, p. 1.

14

(15)  OJ L 198, 8.8.1996, p. 30.

15

(16)  OJ L 227, 1.9.1994, p. 1.

16

(17)  OJ L 78, 24.3.2009, p. 1.

17

(18)  OJ L 3, 5.1.2002, p. 1.

18

(19)  OJ L 93, 31.3.2006, p. 12.

19

(20)  OJ L 299, 16.11.2007, p. 1.

20

(21)  OJ L 149, 14.6.1991, p. 1.

21

(22)  OJ L 39, 13.2.2008, p. 16.

22

(23)  OJ L 199, 31.7.2007, p. 40.

23

(24)  
  Date: 12 months from the date of entry into force of this Regulation.

24

Date: 12 months from the date of entry into force of this Regulation.

(25)  
  Date: 12 months from the date of entry into force of this Regulation.

25

Date: 12 months from the date of entry into force of this Regulation.

(26)  OJ L 124, 8.6.1971, p. 1.

26

(27)  Date of entry into force of this Regulation.

27

(28)  
  Date: 36 months after the entry into force of this Regulation.

28

Date: 36 months after the entry into force of this Regulation.

---