Text · Comparison of two versions
Changes from plenary report to adopted text
A-9-2024-0022 → TA-9-2024-0099
- From
- A-9-2024-0022 Plenary report of 1 Feb 2024
- To
- TA-9-2024-0099 Adopted text of 28 Feb 2024
- Changes
- Not comparable
- Paragraphs
- +524 added · −103 removed · 4 changed
More facts (2)
- Title (from)
- on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)
- Title (to)
- Supplementary protection certificate for medicinal products (recast)
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 10 of 12: Paragraphs 508–567
Added5. All data shall be kept indefinitely. However, the party concerned may request the removal of any personal data from the database after 18 months from the expiry of the certificate or, the case being, the closure of the relevant inter partes procedure. The party concerned shall have the right to obtain the correction of inaccurate or erroneous data at any time.
AddedArticle 37 Transparency
Added1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council shall apply to documents held by the Office.
Added2. The Management Board of the Office shall adopt detailed rules for applying Regulation (EC) No 1049/2001 in the context of this Regulation.
Added3. Decisions taken by the Office under Article 8 of Regulation (EC) No 1049/2001 may be challenged through the European Ombudsman or form the subject of an action before the Court of Justice of the European Union, under the conditions laid down in Articles 228 and 263 TFEU respectively.
Added4. The processing of personal data by the Office shall be subject to Regulation (EC) No 45/2001 of the European Parliament and of the Council.
AddedArticle 38 Representation
Added1. Natural or legal persons having neither their domicile nor their principal place of business or a real and effective industrial or commercial establishment in the European Economic Area shall be represented before the Office in accordance with this Article in all proceedings provided for by Chapter III of this Regulation, other than the filing of a centralised application.
Added2. Natural or legal persons having their domicile or principal place of business or a real and effective industrial or commercial establishment in the European Economic Area may be represented before the Office by an employee.
AddedAn employee of a legal person may also represent other legal persons which are economically linked with the legal person being represented by that employee.
AddedThe second subparagraph also applies where those other legal persons have neither their domicile nor their principal place of business nor a real and effective industrial or commercial establishment within the Union.
AddedEmployees who represent natural or legal persons shall, at the request of the Office or, where appropriate, of the party to the proceedings, file with the Office a signed authorisation for insertion in the files.
Added3. A common representative shall be appointed where there is more than one applicant or more than one third party acting jointly.
Added4. Only a practitioner established in the Union, entitled to act as a professional representative in patent matters before a national patent office or the European Patent Office, or a lawyer authorised to practise before the courts or tribunals of a Member State, may represent natural or legal persons before the Office.
AddedArticle 39 Combined applications
Added1. A centralised application may also include a request for the grant of a unitary certificate, as defined in Regulation [COM(2023) 222] (‘combined application’).
Added2. The combined application shall undergo a single centralised examination procedure, as well as a single opposition or appeal procedure, where it has been filed against an opinion or decision in respect of both the centralised application and the unitary certificate application.
Added3. The Member States for which the basic patent has unitary effect shall not be designated in the combined application for the parallel grant of national certificates. Any designation, in the combined application, of a Member State for which the basic patent has unitary effect shall be disregarded for the purpose of the examination of the combined application.
AddedArticle 40 Supplementary Protection Certificates Division
AddedA Supplementary Protection Certificate Division (‘SPC Division’) shall be set up within the Office and shall be responsible for implementing the tasks set out in Chapter III of this Regulation and in Chapter III of Regulation [COM(2023) 223], as well as in Regulations [COM(2023) 222] and [COM(2023) 221], including in particular:
Added(a) receiving and supervising the examination of centralised applications for certificates, centralised applications for an extension of the duration of certificates, appeals and observations by third parties;
Added(b) adopting examination opinions on behalf of the Office in relation to centralised applications for certificates, as well as in relation to centralised applications for an extension of the duration of certificates;
Added(c) deciding on oppositions against examination opinions;
Added(d) maintaining the register and the database.
AddedArticle 41 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 42 Communications to the Office
Added1. Communications addressed to the Office may be effected by electronic means. The Executive Director shall determine to what extent and under which technical conditions those communications may be submitted electronically.
Added2. The Commission is empowered to adopt delegated acts in accordance with Article 55 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 43 Decisions and communications of the Office
Added1. Decisions of the Office under this Chapter shall include examination opinions and shall state the reasons on which they are based. They shall be based only on reasons or evidence on which the parties concerned have had an opportunity to present their comments. Where oral proceedings are held before the Office, the decision may be given orally. Subsequently, the decision or opinion shall be notified in writing to the parties.
Added2. Any decision, opinion, communication or notice from the Office under this Chapter shall indicate the SPC Division and the relevant panel as well as the name or the names of the examiners responsible. It shall be signed by these examiners, or, instead of a signature, carry a printed or stamped seal of the Office. The Executive Director may determine that other means of identifying the SPC Division and the name of the examiners responsible, or an identification other than a seal, may be used where decisions or other communications are transmitted by any technical means of communication.
Added3. Decisions of the Office under this Chapter which are open to appeal shall be accompanied by a written communication indicating that any notice of appeal is to be filed in writing at the Office within 2 months of the date of notification of the decision in question. That communication shall also draw the attention of the parties to the provisions laid down in Article 29. The parties may not plead any failure on the part of the Office to communicate the availability of appeal proceedings.
AddedArticle 44 Oral proceedings
Added1. If the Office considers that oral proceedings would be expedient they shall be held either at the instance of the Office or at the request of any party to the proceedings.
Added2. Oral proceedings before an examination panel or opposition panel shall not be public. [Am. 62]
Added3. Oral proceedings before an examination panel, an opposition panel or the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the examination panel, the opposition panel or the Boards of Appeal decide otherwise in cases where admission of the public to all or a part of the oral proceedings could have serious and unjustified disadvantages, in particular for a party to the proceedings. [Am. 63]
Added4. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by setting out the detailed arrangements for oral proceedings.
AddedArticle 45 Taking of evidence
Added1. In any proceedings before the Office, the means of giving or obtaining evidence shall include the following:
Added(a) hearing the parties;
Added(b) requests for information;
Added(c) the production of documents and items of evidence;
Added(d) hearing witnesses;
Added(e) opinions by experts;
Added(f) statements in writing sworn or affirmed or having a similar effect under the law of the State in which the statement is drawn up.
Added2. The relevant panel may commission one of its members to examine the evidence adduced.
Added3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summonsed, the Office or the relevant panel, as applicable, shall verify that the person is free of any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period. [Am. 64]
Added4. The parties shall be informed of the hearing of a witness or expert before the Office. They shall have the right to be present and to put questions to the witness or expert.
Added5. The Executive Director shall determine the amounts of expenses to be paid, including advances, as regards the costs of taking of evidence as referred to in this Article.
Added6. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by setting out the detailed arrangements for the taking of evidence.
AddedArticle 46 Notification
Added1. The Office shall, as a matter of course, notify those concerned of decisions, including opinions, summonses and of any notice or other communication from which a time limit is reckoned, or of which those concerned are to be notified under other provisions of this Chapter or of acts adopted pursuant to this Chapter, or of which notification has been ordered by the Executive Director.
Added2. Notification may be effected by different means, including electronic means. The details regarding electronic means shall be determined by the Executive Director.
Added3. Where notification is to be effected by public notice, the Executive Director shall determine how the public notice is to be given and shall fix the beginning of the 1-month period on the expiry of which the document shall be deemed to have been notified.
Added4. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by setting out the detailed arrangements for notification.
AddedArticle 47 Time limits
Added1. Time limits shall be laid down in terms of full years, months, weeks or days. Calculation shall start on the day following the day on which the relevant event occurred. The duration of time limits shall be no less than 1 month and no more than 6 months.
Added2. The Executive Director shall determine, before the commencement of each calendar year, the days on which the Office is not open for receipt of documents or on which ordinary post is not delivered in the locality in which the Office is located.
Sources & citation
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-9-2024-0022/compare/TA-9-2024-0099?all=1&part=10
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 29 September 2026
Cite as
European Parliament (2024). “Changes between A-9-2024-0022 and TA-9-2024-0099”. Text, 28 February 2024. from A-9-2024-0022, to TA-9-2024-0099. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0022/compare/TA-9-2024-0099?all=1&part=10 (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-9-2024-0022 and TA-9-2024-0099}},
year = {2024},
date = {2024-02-28},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0022/compare/TA-9-2024-0099?all=1&part=10}},
url = {https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0022/compare/TA-9-2024-0099?all=1&part=10},
urldate = {2026-09-29},
publisher = {EU Parl Watch Research},
note = {Text. from A-9-2024-0022, to TA-9-2024-0099. Data: European Parliament Open Data (CC BY 4.0)}
}