Text · Comparison of two versions
Changes from plenary report to adopted text
A-9-2024-0019 → TA-9-2024-0097
- From
- A-9-2024-0019 Plenary report of 31 Jan 2024
- To
- TA-9-2024-0097 Adopted text of 28 Feb 2024
- Changes
- Not comparable
- Paragraphs
- +500 added · −76 removed · 0 changed
More facts (2)
- Title (from)
- on the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
- Title (to)
- Unitary supplementary certificate for medicinal products
These two texts have too little in common to be compared paragraph by paragraph (under 15 % of their paragraphs match): they are different documents rather than versions of one — for example a group’s motion and the joint text that was adopted.
Every difference
The full paragraph comparison, packaging included; long runs of unchanged paragraphs are folded. One part of the text per page.
Part 7 of 10: Paragraphs 361–420
Added3. A request for conversion may be filed with the Office within 3 months after notification of the revocation of the unitary effect of the basic patent.
Added4. A request for conversion, as well as its outcome, shall be published in the Register.
Added5. The Office shall check whether the conversion requested fulfils the conditions set out in this Article, together with the formal conditions specified in the implementing act adopted pursuant to paragraph 8. If the conditions governing the request are not fulfilled, the Office shall notify the applicant of the deficiencies. If the deficiencies are not remedied within a period to be specified by the Office, the Office shall reject the request for conversion. Where the conversion fee has not been paid within the relevant period of 3 months, the Office shall inform the applicant that the request for conversion is deemed not to have been filed.
Added6. Where a request under paragraph 1 complies with paragraph 5, the Office shall convert the application for a unitary certificate into a centralised application for certificates designating the Member States in which the basic patent had unitary effect. In the event of a combined application, the designation of the Member States in which the basic patent had unitary effect shall be added to the designation of other Member States already included in the combined application.
Added7. Where a request under paragraph 2 complies with paragraph 5, the Office shall transmit the request for conversion to the competent national authorities of each Member State in which the basic patent had unitary effect and for which the request has been found admissible. The competent national authorities shall take decisions accordingly.
Added8. The Commission shall adopt implementing acts specifying the details to be contained in a request for conversion of the for a unitary certificate or unitary certificate into a centralised application for certificates or national certificates. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.
AddedArticle 28 Appeals
Added1. Any party to proceedings under this Regulation, adversely affected by a decision of the Office, including the adoption of an examination opinion, may appeal the decision to the Boards of Appeal.
Added2. The filing of the appeal shall have suspensive effect. A decision of the Office that has not been contested shall take effect on the day following the date of expiry of the appeal period referred to in paragraph 3.
Added3. Notice of appeal shall be filed in writingelectronically at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, including the evidence supporting those grounds, shall be filed electronically within 4three months of the date of notification of the decision.
AddedAny reply to the statement of grounds of appeal shall be submitted in writing no later than three months from the date of the filing of the statement of grounds of appeal. The Office shall, where applicable, fix a date for oral proceedings within three months of the filing of the reply or within six months following the filing of the statement of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the date of the oral hearing or of the filing of the reply to the statement of grounds of appeal, as applicable. [Am. 56]
Added4. Following an examination of admissibility of the appeal, the Boards of Appeal shall decide on the merits of the appeal.
Added5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards mayshall annul or alter the opinion. [Am. 57]
Added6. An action may be brought before the General Court of the European Union against a decision of the Boards of Appeal in relation to appeals, within 2 months of the date of notification of that decision, on grounds of infringement of an essential procedural requirement, infringement of the Treaty on the Functioning of the European Union, infringement of this Regulation or of any rule of law relating to their application or misuse of power. The action shall be open to any party to proceedings before the Board of Appeal adversely affected by its decision. The General Court shall have jurisdiction to annul or to alter the contested decision.
Added7. The decisions of the Boards of Appeal shall take effect on the day following the date of expiry of the period referred to in paragraph 6 or, if an action has been brought before the General Court within that period, as from the date following the day of dismissal of such action or of dismissal of any appeal filed with the Court of Justice of the European Union against the decision of the General Court. The Office shall take the necessary measures to comply with the judgement of the General Court or, in the event of an appeal against that judgement, the Court of Justice.
Added8. The Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by specifying the content and form of the notice of appeal referred to in paragraph 3, the procedure for the filing and examination of an appeal and the content and the form of the Boards of Appeal’s decision referred to in paragraph 4.
AddedArticle 29 Boards of Appeal
Added1. In addition to the powers conferred upon it by Article 165 of Regulation (EU) 2017/1001, the Boards of Appeal instituted by that Regulation shall be responsible for deciding on appeals against decisions of the Office taken on the basis of Article 25(1).
Added2. A Board of Appeal in matters regarding unitary certificates shall consist of three members, at least two of whom are legally qualified. Where the Board of Appeal considers that the nature of the appeal so requires, it may call up to two further members for that case.
Added3. There shall be no Grand Board as referred to in Article 165(2), (3) and (4), and Article 167(2) of Regulation (EU) 2017/1001 in matters regarding unitary certificates. Decisions taken by a single member as under Article 165(2) of Regulation (EU) 2017/1001 shall not be possible.
Added4. Members of the Boards of Appeal in matters regarding unitary certificates shall be appointed in accordance with Article 166(5) of Regulation (EU) 2017/1001. When appointing members of the Boards of Appeal in matters concerning applications for unitary certificates, due consideration shall be given to their previous experience in matters concerning supplementary protection certificates or patent law. [Am. 58]
Added4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to Boards of Appeal in matters regarding unitary certificates. [Am. 59]
AddedArticle 30 Delegation of power regarding the Boards of Appeal
AddedThe Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by specifying the details concerning the organisation of the Boards of Appeal in proceedings relating to unitary certificates under this Regulation.
AddedArticle 31 Fees
Added1. The Office shall charge a fee for an application for a unitary certificate, and for an application for the extension of the duration of a unitary certificate.
Added2. The Office shall charge a fee for appeals, for oppositions, for applications for a declaration of invalidity and for conversions.
Added3. The unitary certificate shall be subject to the payment of annual maintenance fees to the Office.
Added4. The notifications referred to in Article 5(3), points (b) and (c), shall be subject to the payment of a fee to the Office.
Added5. The Commission is empowered to adopt implementing acts determining the amounts of the fees charged by the Office, the time limits within which they have to be paid, and the ways in which they are to be paid. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.
AddedArticle 32 Combined applications
AddedAn application for a unitary certificate may be included in a combined centralised application in which the applicant also requests the grant of national certificates, in the designated Member States, in accordance with the centralised procedure under Regulation [COM(2023) 231]. In that case, Article 39 of that Regulation shall apply.
AddedAn applicant shall submit an application for a combined centralised application electronically to the Office and in the formats made available by the Office. [Am. 60]
AddedArticle 33 Languages
Added1. All documents and information sent to the Office in respect of the procedures under this Regulation shall be in one of the official languages of the Union.
Added2. For the tasks conferred on the Office under this Regulation, the languages of the Office shall be all the official languages of the Union in accordance with Council Regulation No 1.
AddedArticle 34 Communications to the Office
Added1. Communications addressed to the Office mayshall be effected by electronic means. The Executive Director shall determine to what extent and under which technical conditions those communications mayare to be submitted electronically. [Am. 61]
Added2. The Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office.
AddedArticle 35 Register
Added1. As regards applications for unitary certificates for medicinal products, the Register set up under Article 35 of Regulation [COM(2023) 231] shall include, for each unitary certificate, or application for a unitary certificate, or application for an extension of the duration of a unitary certificate, the following information, as applicable:
Added(a) the name and address of the applicant or certificate holder;
Added(b) the name and business address of the representative, other than a representative as referred to in Article 38(3);
Added(c) the application as well as its date of lodging and date of publication;
Added(d) whether the application relates to a medicinal product or to a plant protection product;
Added(e) where applicable, an indication that the application includes an application for an extension of the duration;
Added(f) the number of the basic patent;
Added(g) an identification of the product for which a unitary certificate is requested;
Added(h) the number and date of the authorisation to place the product on the market referred to in Article 3(1), point (b), and an identification of the product identified therein;
Added(i) the number and date of the first authorisation to place the product on the market in the Union;
Added(ia) information on any direct public financial support received for research related to the development of the product; [Am. 62]
Added(j) the date and a summary of the examination opinion of the Office in respect of each of the Member States in which the basic patent has unitary effect; [Am. 63]
Added(k) where applicable, the number and the duration of the unitary certificate;
Added(l) where applicable, the date and a summary of the examination opinion relating to an application for an extension of the duration of a unitary certificate;
Added(m) where applicable, the filing of an opposition, its status and the outcome of the opposition proceedings, including where applicable a summary of the revised examination opinion; [Am. 64]
Added(n) where applicable, the filing of an appeal, its status and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion; [Am. 65]
Added(o) where applicable, a mention that a certificate has lapsed or was declared invalid;
Added(p) where applicable, the filing of an application for a declaration of invalidity and, once available, the outcome of the related proceedings;
Added(q) where applicable, information relating to a request for conversion, and its outcomes;
Added(r) information on the payment of annual fees.
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Where the facts on this page come from, and how to cite it.
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- https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0019/compare/TA-9-2024-0097?all=1&part=7
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 29 September 2026
Cite as
European Parliament (2024). “Changes between A-9-2024-0019 and TA-9-2024-0097”. Text, 28 February 2024. from A-9-2024-0019, to TA-9-2024-0097. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0019/compare/TA-9-2024-0097?all=1&part=7 (retrieved 29 September 2026). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX
@misc{epw-text-2024-02-28,
author = {{European Parliament}},
title = {{Changes between A-9-2024-0019 and TA-9-2024-0097}},
year = {2024},
date = {2024-02-28},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0019/compare/TA-9-2024-0097?all=1&part=7}},
url = {https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0019/compare/TA-9-2024-0097?all=1&part=7},
urldate = {2026-09-29},
publisher = {EU Parl Watch Research},
note = {Text. from A-9-2024-0019, to TA-9-2024-0097. Data: European Parliament Open Data (CC BY 4.0)}
}