Changes from plenary report to adopted text

Added(8) Article 89 is replaced by the following:

Added‘Article 89

AddedExercise 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 5a, 27, 39, 45, 63(1) and 70 shall be conferred on the Commission for a period of five years from the date referred to in Article 99(2). The Commission shall draw up a report in respect of the delegated powers not later than nine months before the end of the five year period. The delegation of powers shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Added3. The delegation of power referred to in Articles 5a, 27, 39, 45, 63(1), and 70 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 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 Articles 5a, 27, 39, 45, 63(1), and 70 shall enter into force only if no objection has been expressed either by the European Parliament or 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 the Council.;’

Added(9) Article 91 is replaced by the following:

Added‘Article 91

AddedRelation with other Union legal acts

Added‘This Regulation shall be without prejudice to Council Directive 97/43/Euratom, Council Directive 96/29/Euratom, Directive 2004/23/EC of the European Parliament and of the Council, Directive 2002/98/EC of the European Parliament and of the Council and Directive 2010/53/EU of the European Parliament and of the Council.

AddedIn the context of inspections referred under Articles 52(5) of [revised Regulation 726/2004] and Article 78 of this Regulation and the criteria set out in Annex III of [revised Regulation 726/2004] apply mutatis mutandis.’

AddedArticle 178 Amendments to Regulation (EU) 2022/123

AddedRegulation (EU) No 2022/123 is amended as follows:

Added1. In Article 18, the following paragraph (7) is added:

Added‘(7) Where a request has been made in accordance with Article 18(3) of Regulation (EU) 2022/123 and there is an application for a temporary emergency marketing authorisation for the medicinal product concerned in accordance with Article 30 of Regulation [Note to OP: Please fill in with the number of this Regulation]*, the procedure initiated under that Regulation shall prevail.’

Added* [OP: Insert the full title of that Regulation and the OJ reference, please]’

Added2. Articles 33 and 34 are deleted.

AddedCHAPTER XV FINAL PROVISIONS

AddedArticle 179 Repeals

Added1. Regulations (EC) No 141/2000, (EC) No 726/2004 and (EC) No 1901/2006 are repealed.

AddedReferences to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex V.

Added2. Commission Implementing Regulation (EU) No 198/2013 is repealed.

AddedArticle 180 Transitional provisions

Added1. The provisions of Article 117 of this Regulation shall also apply to marketing authorisations of medicinal products for human use granted in accordance with Regulation (EC) No 726/2004 and in accordance with Directive 2001/83/EC before [Note to the OP: Please insert the date = date of entry into application of this Regulation].

Added2. The procedures concerning the applications for marketing authorisations for medicinal products for human use that have been validated, in accordance with Article 5 of Regulation (EC) No 726/2004, before [Note to the OP: Please insert the date = date of entry into application of this Regulation] and that were pending on [Note to the OP: Please insert the date = the day before the date of application of this Regulation] shall be completed in accordance with Article 10 of Regulation (EC) No 726/2004.

Added3. Procedures concerning imposed post-authorisation studies that were initiated in accordance with Article 10a of Regulation (EC) No 726/2004, before [Note to the OP: Please insert the date = date of entry into application of this Regulation] and that were pending on [Note to the OP: Please insert the date = the day before the date of application of this Regulation] shall be completed in accordance with Article 20 of this Regulation.

Added4. By way of derogation, the periods of regulatory protection referred to in Article 29 shall not apply to reference medicinal products for which an application for marketing authorisation has been submitted before [Note to the OP: Please insert the date of application of this Regulation]. Article 14(11) of Regulation (EC) No 726/2004 shall continue to apply to them.

Added5. Orphan designations granted before [Note to the OP: Please insert the date of application of this Regulation], entered in and not removed from the Community Register of Orphan Medicinal Products in accordance with Article 5, paragraphs 8 and 12, respectively, of Regulation (EC) No 141/2000 and not granted a marketing authorisation in accordance with Article 7(3) of Regulation (EC) No 141/2000 corresponding to the orphan designation shall be considered to comply with this Regulation and shall be entered in the Register of Designated Orphan Medicinal Products.

Added6. Orphan designations granted before [Note to the OP: Please insert the date of application of this Regulation] which are either removed from the Community Register of Orphan Medicinal Products in accordance with Article 5(12) of Regulation (EC) No 141/2000 or granted a marketing authorisation in accordance with Article 7(3) of Regulation (EC) No 141/2000 shall not be considered as orphan designations and shall not be entered in the Register of Designated Orphan Medicinal Products.

Added7. The 7-year validity of an orphan designation referred to in Article 66 of this Regulation for orphan medicinal products granted before [Note to the OP: Please insert the date of application of this Regulation], entered in and not removed from the Community Register of Orphan Medicinal Products in accordance with Article 5 (8) and (12), respectively, of Regulation (EC) No 141/2000 and not granted a marketing authorisation in accordance with those Article 7(3) of Regulation (EC) No 141/2000 corresponding to the orphan designation shall begin to run from [Note to the OP: Please insert the date of application of this Regulation].

Added8. The procedures concerning orphan designations which were initiated in accordance with Article 5, paragraphs 1, 11 or 12 of Regulation (EC) No 141/2000 before [Note to the OP: Please insert the date of application of this Regulation] and were pending on [OP please insert the date = the day before the date of application], shall be completed in accordance with Article 5, paragraphs 1, 11 or 12 of Regulation (EC) No 141/2000 as applicable on [OP please insert the date = the day before the date of application].

Added9. When a paediatric investigation plan, a waiver or a deferral has been granted in accordance with Regulation (EC) No 1901/2006 before [Note to the OP: Please insert the date of application of this Regulation], it shall be considered to comply with this Regulation.

AddedThe procedures concerning the application for a paediatric investigation plan, a waiver or a deferral submitted before [date of entry into application], shall be completed in accordance with Regulation (EC) No 1901/2006.

Added10. Regulations (EC) No 2141/96, (EC) No 2049/2005, (EC) No 507/2006 and (EC) No 658/2007 shall remain in force and continue to apply unless and until repealed.

Added11. Regulation (EC) No 1234/2008 shall continue to apply unless and until repealed as regards medicinal products for human use that are covered by Regulation (EC) No 726/2004 and Directive 2001/83/EC and that are not excluded from the scope of Regulation (EC) No 1234/2008 pursuant to Article 23b, paragraphs 4 and 5 of Directive 2001/83/EC.

Added12. Commission Regulation (EC) No 847/2000 shall continue to apply unless and until repealed as regards orphan medicinal products that are covered by this Regulation.

Added13. By way of derogation from Article [Duration of application of Chapter III] vouchers granted until [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with Chapter III, whichever date is the earliest, shall continue to be valid according to the conditions set out in Chapter III.

AddedArticle 181 Entry into force

AddedThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

AddedIt shall apply from [Note to the OP: Please insert the date of 18 months after its entry into force. The date should be identical to the date for the application of the Directive].

AddedHowever, Article 67 shall apply from [Note to the OP: Please insert the date of 2 years after the date of adoption/entry into force/application of this Regulation].

AddedThe provisions in Chapter III shall apply from ... [the date of entry into force of this Regulation]. [Am. 361]

AddedThis Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.

AddedDone at …,

AddedFor the European Parliament For the Council

AddedThe President The President

AddedAnnex I

AddedMEDICINAL PRODUCTS TO BE AUTHORISED BY THE UNION

Added1. Medicinal products developed by means of one of the following biotechnological processes:

Added- recombinant nucleic acid technology;

Added- controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells.

Added2. Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007.

Added3. Medicinal products for human use containing an active substance which on 20 May 2004 was not authorised in the Union, excluding allergen products or herbal medicinal products, which shall in any case not be authorised by the Union.

Added4. Medicinal products that are designated as orphan medicinal products pursuant to this Regulation.

Added5. Medicinal products authorised in accordance with a paediatric use marketing authorisation.

Added6. Priority antimicrobials as referred to in Article 40.

AddedAnnex II