What changed between the adopted text of 13 Mar 2024 and the adopted text of 16 Dec 2025

Removed:2. Customs authorities shall rely on the Union compulsory license and modifications thereof to identify products that may fall under the prohibition laid down in Article 11. For that purpose, risk information as regards each Union compulsory licence and any modification thereof shall be entered in the relevant customs risk management system. Customs authorities shall take such risk information into consideration when they carry out controls on products placed under the customs procedure ‘export’ in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.

Removed:3. Where customs authorities identify a product that may fall under the prohibition laid down in Article 11, they shall suspend its export. Customs authorities shall immediately notify the Commission of the suspension and provide it with all relevant information to enable it to establish whether the product was manufactured under a Union compulsory license. To assess whether the suspended products correspond to the Union compulsory license, the Commission may consult the relevant rights-holder.

Removed:4. Where the export of a product has been suspended in accordance with paragraph 3, the product shall be released for export provided that all the other requirements and formalities under Union or national law relating to such export have been fulfilled, and either of the following conditions is fulfilled:

Removed:(a) the Commission has not requested the customs authorities to maintain the suspension within 10 working days after it was notified thereof;

Removed:(b) the Commission has informed the customs authorities that the product is not manufactured under a Union compulsory licence.

Removed:5. Where the Commission concludes that a product manufactured under a Union compulsory licence does not comply with the prohibition laid down in Article 11, customs authorities shall not authorise its release for export. The Commission shall inform the concerned rights-holder of such non-compliance.

Removed:6. Where the release for export of a product has not been authorised:

Removed:(a) where appropriate in view of the crisis or emergency context, the Commission may require customs authorities to oblige the exporter to take specific actions at their own costs, including supplying them to designated Member States, if need be, after rendering them compliant with Union law.

Removed:(b) in all other cases, customs authorities may take any necessary measure to ensure that the product concerned is disposed of in accordance with national law consistent with Union law. Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly.

Removed:Article 13 Relations between rights-holder and licensee

Removed:1. The relations between the rights-holder and the licensee who has been granted a Union compulsory license shall act and cooperate with each other in good faith when performing rights and obligations under this Regulation.

Removed:2. In compliance with the good faith obligation, the rights-holder and the licensee shall make their best efforts to fulfil the objective of the Union compulsory licence, taking into account each other's interests as well as the public interest. [Am. 65]

Removed:Article 13a Additional measures complementing the Union compulsory licence

Removed:1. Where necessary, the Commission shall decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.

Removed:2. Where strictly necessary, the Commission shall request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee shall be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.

Removed:3. Where the rights-holder is requested to disclose his trade secrets in accordance with paragraph 3, the Commission shall, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties, including, as appropriate, the use of model contractual terms, confidentiality agreements, strict access protocols, technical standards or the application of codes of conduct. If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.

Removed:4. Appropriate remuneration to the rights-holders in compensation for the disclosure of their trade secrets shall be granted in accordance with Directive (EU) 2016/943.

Removed:5. Where the Commission considers adopting additional measures as referred to in paragraphs 1 and 2, it shall consult the advisory body referred to in Article 6.

Removed:6. The implementing acts referred to in paragraphs 1 and 2 shall be adopted in accordance with the rules referred to in Article 7(6), points (a) and (b), and Article 7(7) and (8). [Am. 66]

Removed:Article 14 Review and termination of the Union compulsory licence

Removed:1. The Commission shall review the Union compulsory licence upon reasoned request by the rights-holder or the licensee or on its own initiative and shall, where needed, modify the specifications referred to in Article 8 by means of an implementing act. Where necessary, the Union compulsory licence shall be modified to indicate the complete list of rights and rights-holders covered by the compulsory licence.

Removed:2. Where necessary, the Commission shall decide upon reasoned request by the rights-holder or the licensee or on its own initiative on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee. [Am. 67]

Removed:3. A Union compulsory licence may be terminated by the Commission by means of an implementing act where the circumstances which led to it cease to exist and are unlikely to recur or where the licensee fails to comply with the obligations laid down in this Regulation.

Removed:4. When the Commission considers modifying, adopting additional measures as referred to in paragraph 2, or terminating the Union compulsory licence, it mayshall consult the advisory body referred to in Article 6 as well as the rights-holders and licensees. [Am. 68]

Removed:4a. When considering terminating the Union compulsory licence, the Commission shall ensure that a sufficient transitional period is put in place. [Am. 69]

Removed:5. When terminating the Union compulsory licence, the Commission may require that the licensee, within a reasonable period of time, arrange for any goods in its possession, custody, power or control to be redirected or otherwise disposed of in the manner determined by the Commission in consultation with the rights-holder and at the expense of the licensee.

Removed:6. The implementing acts referred to in paragraph 1, 2 and 3 shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8). [Am. 70]

Removed:Article 15 Fines

Removed:1. The Commission may by decision impose on the licensee or the rights-holder fines not exceeding 6 % of their respective total turnover in the preceding business year where, intentionally or negligently:

Removed:(a) the licensee fails to comply with its obligations under Article 9(1) or Article 10(1);

Removed:(b) the rights-holder or the licensee fail to comply with the principle of good faith and cooperation referred to in Article 13; or

Removed:(c) the rights-holder or the licensee fail to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and 14(2)Article 13a(1) and (2), as specified in the relevant implementing act. [Am. 71]

Removed:(ca) the licensee does not comply with the prohibition referred in Article 11; [Am. 72]

Removed:2. In fixing the amount of the fine, regard shall be had to the gravity, to the recurrence of the infringement and to the duration of the infringement.

Removed:Article 16 Periodic penalty payments

Removed:1. The Commission may, by decision, impose on the licensee or the rights-holder periodic penalty payments not exceeding 5 % of their respective average daily turnover in the preceding business year per day and calculated from the date appointed by the decision, in order to compel:

Removed:(a) the licensee to put an end to an infringement of its obligations under Article 10(1);

Removed:(b) the licensee and the rights-holder to put an end to the infringement of Article 13; or

Removed:(c) the rights-holder or the licensee to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and 14(2)Article 13a(1) and (2), as specified in the relevant implementing act. [Am. 73]

Removed:(ca) the licensee to put an end to an infringement of the prohibition referred in Article 11; [Am. 74]

Removed:2. Where the licensee or the rights-holder have satisfied the obligation which the periodic penalty payment was intended to enforce, the Commission may fix the definitive amount of the periodic penalty payment at a figure lower than that which would arise under the original decision.

Removed:Article 17 Limitation period for the imposition of fines and periodic penalty payments

Removed:1. The powers conferred on the Commission by Articles 15 and 16 shall be subject to a limitation period of five years.

Removed:2. Time shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, time shall begin to run on the day on which the infringement ceases.

Removed:3. Any action taken by the Commission or by a competent authority of the Member States for the purpose of the investigation or proceedings in respect of an infringement shall interrupt the limitation period for the imposition of fines or periodic penalty payments.

Removed:4. Each interruption shall start time running afresh. However, the limitation period for the imposition of fines or periodic penalty payments shall expire at the latest on the day on which a period equal to twice the limitation period has elapsed without the Commission having imposed a fine or a periodic penalty payment. That period shall be extended by the time during which the limitation period has been suspended pursuant to paragraph 5.

Removed:5. The limitation period for the imposition of fines or periodic penalty payments shall be suspended for as long as the decision of the Commission is the subject of proceedings pending before the Court of Justice of the European Union.

Removed:Article 18 Limitation period for the enforcement of fines and periodic penalty payments

Removed:1. The power of the Commission to enforce decisions taken pursuant to Articles 15 and 16 shall be subject to a limitation period of five years.

Removed:2. Time shall begin to run on the day on which the decision becomes final.

Removed:3. The limitation period for the enforcement of penalties shall be interrupted:

Removed:(a) by notification of a decision varying the original amount of the fine or periodic penalty payment or refusing an application for variation;

Removed:(b) by any action of the Commission, or of a Member State acting at the request of the Commission, designed to enforce payment of the fine or periodic penalty payment.

Removed:4. Each interruption shall start time running afresh.

Removed:5. The limitation period for the enforcement of penalties shall be suspended for so long as:

Removed:(a) time to pay is allowed;

Removed:(b) enforcement of payment is suspended pursuant to a decision of the Court of Justice of the European Union or to a decision of a national court.

Removed:Article 19 Right to be heard and access to the file

Removed:1. Before adopting a decision pursuant to Article 15 or 16, the Commission shall give the licensee or the rights-holder the opportunity of being heard and fully involved in the procedure on the alleged infringement which is to be made subject to a fine or periodic penalty payments. [Am. 75]

Removed:2. The licensee or the rights-holder may submit its observations on the alleged infringement within a reasonable period set by the Commission, which may not be less than 14 days.