Changes from plenary report to adopted text

Added‘(f) a supplementary protection certificate for medicinal products as provided for in Regulation [COM(2023) 231] of the European Parliament and of the Council of ddddd concerning the supplementary protection certificate for medicinal products [OP, please insert the No and date of COM(2023) 231 once adopted, as well as its O.J. reference in the footnote];

Added(g) a supplementary protection certificate for plant protection products as provided for in Regulation [COM(2023) 223] of the European Parliament and of the Council of ddddd concerning the creation of a supplementary protection certificate for plant protection products [OP, please insert the No and date of COM(2023) 223 once adopted, as well as its O.J. reference in the footnote];;’

Added(2) the following points (m) and (n) are inserted:

Added‘(m) a unitary supplementary protection certificate for medicinal products as provided for in Regulation [COM(2023) 222] of the European Parliament and of the Council of ddddd on the unitary supplementary protection certificate for medicinal products and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013 [OP, please insert the No and date of COM(2023) 222 once adopted, as well as its O.J. reference in the footnote];

Added(n) a unitary supplementary protection certificate for plant protection products as provided for in Regulation [COM(2023) 221] of the European Parliament and of the Council of dddddd on the unitary supplementary protection certificate for plant protection products [OP, please insert the No and date of COM(2023) 221 once adopted, as well as its O.J. reference in the footnote]..’

AddedArticle 52 Amendment to Regulation (EC) No 1901/2006

AddedRegulation (EC) No 1901/2006 is amended as follows:

Added(1) in Article 2, point (4) is replaced by the following:

Added‘(4) ‘paediatric use marketing authorisation’ means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate or unitary supplementary protection certificate under Regulation [COM(2023) 231] or Regulation [COM(2023) 222], or by a patent which qualifies for the grant of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product;;’

Added(2) in Article 8, the first paragraph is replaced by the following:

Added‘In the case of authorised medicinal products which are protected either by a supplementary protection certificate or unitary supplementary protection certificate under Regulation [COM(2023) 231] or Regulation [COM(2023) 222], or by a patent which qualifies for the grant of the supplementary protection certificate, Article 7 of this Regulation shall apply to applications for authorisation of new indications, including paediatric indications, new pharmaceutical forms and new routes of administration.;’

Added(3) Article 36 is amended as follows:

Added(a) in paragraph 1, the first subparagraph is replaced by the following:

Added‘Where an application under Article 7 or 8 includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate or unitary supplementary protection certificate shall be entitled to a six-month extension of the periods referred to in Articles 13(1) and 13(2) of Regulation [COM(2023) 231] or Article 20(1) and 20(2) of Regulation [COM(2023) 222].;’

Added(b) in paragraph 4, the first sentence is replaced by the following:

Added‘Paragraphs 1, 2 and 3 shall apply to products that are protected by a supplementary protection certificate or unitary supplementary protection certificate under Regulation [COM(2023) 231] or Regulation [COM(2023) 222], or under a patent which qualifies for the grant of the supplementary protection certificate..’

AddedArticle 53 Financial provisions

Added1. The expenses incurred by the Office in carrying out the additional tasks given to it in accordance with this Regulation shall be covered by the procedural fees to be paid to it by applicants and by a fraction of the annual fees paid by the holders of unitary certificates, while the remainder of the annual fees shall be shared with the Member States in accordance with the number of unitary certificates having legal effect in each of them. The fraction of the annual fees to be shared with Member States shall initially be set at a certain value but shall be reviewed every 5 years, in such a manner as to achieve financial sustainability for the activities carried out by the Office under this Regulation as well as under Regulations [COM(2023) 231], [COM(2023) 223] and [COM(2023) 221].

Added2. For the purposes of paragraph 1, the Office shall keep an account of the annual fees paid to it by holders of unitary certificates in force in the respective Member States.

Added3. The expenses incurred by a competent national authority participating in proceedings under this Chapter shall be covered by the Office and shall be paid annually, on the basis of the number of proceedings in which that competent national authority was involved during the preceding year.

Added4. The Commission is empowered to adopt implementing acts laying down rules on the financial transfers between the Office and Member States, the amounts of those transfers, and the remuneration to be paid by the Office regarding the participation of competent national authorities referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

Added5. Article 12 of Regulation (EU) No 1257/2012 shall apply to the annual fees due in respect of unitary certificates.

AddedArticle 54 Exercise of the delegation

Added1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

Added2. The power to adopt delegated acts referred to in Articles 15(13), 23(13), 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) and 47(3) shall be conferred on the Commission for an indeterminate period of time from XXX [OP please insert the date = date of entry into force].

Added3. The delegation of power referred to in Articles 15(13), 23(13), 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) and 47(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on 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.

Added4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

Added5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

Added6. A delegated act adopted pursuant to Article 15(13), 23(13), 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) or 47(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two 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 two months at the initiative of the European Parliament or of the Council.

AddedArticle 55 Committee procedure

Added1. The Commission shall be assisted by a Committee on Supplementary Protection Certificates established by Regulation [COM(2023) 231]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Added2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

AddedArticle 56 Evaluation

AddedBy xxxxxx... [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulationand present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. Special emphasis shall be given to the effects of opposition under Article 15 and whether the possibility of opposition leads to significant delays in granting unitary certificates and to the effects of this Regulation on the recovery of research and development investments in the light of Directive (EU) XXX/XX [COM(2023)192]. [Am. 73]

AddedArticle 57 Entry into force and application

AddedThis Regulation shall enter into force on XXX [OP – please insert the date - the 20th day following its publication in the Official Journal of the European Union].

AddedIt shall apply from xxxxx [OP please insert first day of the 12th month after the date of entry into force].

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

AddedDone at …,

AddedFor the European Parliament For the Council

AddedThe President The President

AddedAnnex I

AddedLogo

AddedThis logo shall appear in black and in such a size as to be sufficiently visible.

AddedAnnex II

AddedStandard form for notification pursuant to Article 5(3), points (b) and (c).