Changes from plenary report to adopted text

Added2. In respect of a centralised application, where a positive examination opinion has been issued for one or more designated Member State, the competent national authority of each of those Member States shall grant a certificate in accordance with applicable national rules and procedures.

Added3. By way of derogation from paragraph 2, a Member State may decide not to grant a certificate, where material circumstances, in that Member State, have changed since the filing of the centralised application in respect of one or more of the conditions laid down in Article 15(1), points (b) or (c), or Article 14, first paragraph, point (d). In such a case that Member State shall reject the application insofar as that Member State is concerned.

Added4. A certificate granted by a competent national authority under this Article shall be subject to Articles 4, 5, 11 and 12 to 19, and to the applicable national legislation.

Added5. Where a negative examination opinion has been issued for one or more designated Member State, the competent national authority of each of those Member States shall issue a rejection decision according to its applicable national rules and procedures.

Added5a. The competent national authority shall inform the applicant of its decision without undue delay. [Am. 54]

AddedArticle 33 Centralised application for an extension of the duration of certificates

Added1. Where certificates for a given medicinal product have been granted through the centralised procedure, their holder may request an extension of the duration of those certificates by filing a centralised application for an extension of the duration of those certificates with the Office. That centralised application shall specify the designation of the Member States for which the extension is requested.

Added2. The centralised application for an extension of the duration of certificates shall be filed in accordance with Article 7(3) and (4), Article 8(1), point (d), Article 8(2), (3) and (4).

Added3. Articles 10, 11 and 17 shall apply, whereby references to ‘the authority referred to in Article 9(1)’ shall be understood as references to the Office.

Added4. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of certificates. [Am. 55]

AddedArticle 34 Fees

Added1. The Office shall charge a fee for a centralised application for certificates, and for a centralised application for the extension of the duration of a certificate.

Added2. The Office shall charge a fee for an appeal, and for an opposition.

Added3. The Commission is empowered to adopt implementing acts to determine the amounts of the fees charged by the Office, the time limits within which they have to be paid, and the ways in which those fees are to be paid. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.

Added4. Article 12 shall apply to certificates granted under this Chapter.

AddedArticle 35 Register

Added1. The Office shall develop, keep and maintain an electronic, searchable and public Register, providing up-to-date information regarding the status of all published centralised applications, and of all centralised applications for an extension of the duration of certificates. [Am. 56]

Added2. The Register shall include, for each centralised application or certificate, all of the following information:

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 37(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 designated Member States;

Added(g) the number of the basic patent;

Added(h) an identification of the product for which certificates are requested;

Added(i) 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(j) the number and date of the first authorisation to place the product on the market in the Union;

Added(ja) information on any direct public financial support received for research related to the development of the product; [Am. 57]

Added(k) the date and a summary of the examination opinion in respect of each of the designated Member States; [Am. 58]

Added(l) where applicable, the duration of the certificates to be granted;

Added(m) where applicable, the date and a summary of the examination opinion relating to an application for an extension of the duration of a certificate;

Added(n) where applicable, the filing of an opposition, its status and its outcome, including where applicable a summary of the revised examination opinion; [Am. 59]

Added(o) 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. 60]

Added(p) where applicable and available, the particulars of the certificates granted in each of the designated Member States;

Added(q) where applicable, a mention that the centralised application was rejected in one or more of the designated Member States;

Added(r) where applicable, a mention that a certificate has lapsed or was declared invalid;

Added(s) information on the payment of annual fees, as provided by the relevant competent national authorities.

Added3. The Register shall contain changes to the information in paragraph 2, including transfers, each accompanied by the date of recording of such entry.

Added4. The Register and information referred to in paragraphs 2 and 3 shall be available in all official languages of the Union. The Office may use verified machine translation for the information to be published in the Register.

Added5. Competent national authorities shall promptly share with the Office information relating to the grant, lapse, invalidity or transfers of certificates and to the rejection of applications under Chapters II and III, and to the payment of related annual fees.

Added6. The Executive Director of the Office may determine that information other than those referred to in paragraphs 2 and 3 shall be entered in the Register.

Added7. The Office shall collect, organise, make public and store the information referred to in paragraphs 2 and 3, including any personal data, for the purposes laid down in paragraph 10. The Office shall keep the Register easily accessible for public inspection.

Added8. The Office shall provide certified or uncertified extracts from the Register on request and on payment of a fee.

Added9. The processing of the data concerning the entries set out in paragraphs 2 and 3, including any personal data, shall take place for the purposes of the following:

Added(a) administering the applications in accordance with this Chapter and the acts adopted pursuant to it;

Added(b) maintaining the Register and making it available for inspection by public authorities and economic operators;

Added(c) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system.

Added10. All the data, including personal data, concerning the entries in paragraphs 2 and 3 shall be considered to be of public interest and may be accessed by any third party free of charge. For reasons of legal certainty, the entries in the Register shall be kept for an indefinite period of time.

Added11. The Register set up under this Article shall also be used to publish information relating to certificates for plant protection products under Regulation [COM(2023) 223], and relating to unitary certificates under Regulation [COM(2023) 222] and Regulation [COM(2023) 221].

Added11a. By way of derogation of Article 35(9)(b) public authorities shall not use the information provided for in the register for practices of patent linkage and no regulatory or administrative decisions related to generics or biosimilar shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids. [Am. 61]

AddedArticle 36 Database

Added1. In addition to the obligation to keep a Register, the Office shall collect and store in an electronic database all the particulars provided by applicants or any other third party observations pursuant to this Regulation or acts adopted pursuant to it.

Added2. The electronic database may include personal data, beyond those included in the Register, to the extent that such particulars are required by this Regulation or by acts adopted pursuant to it. The collection, storage and processing of such data shall serve the purposes of:

Added(a) administering the applications and/or certificate registrations as described in this Regulation and in acts adopted pursuant to it;

Added(b) accessing the information necessary for conducting the relevant proceedings more easily and efficiently;

Added(c) communicating with the applicants and other third parties;

Added(d) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system.

Added3. The Executive Director shall determine the conditions of access to the electronic database and the manner in which its contents, other than the personal data referred to in paragraph 2 of this Article but including those listed in Article 35(3), may be made available in machine-readable form, including the charge for such access.

Added4. Access to the personal data referred to in paragraph 2 shall be restricted and such data shall not be made publicly available unless the party concerned has given his express consent.