144 Amendments of Tomislav SOKOL related to 2023/0131(COD)

Proposal for a regulation
Recital 30 a (new)

(30 a) To support evidence-based policy making, the Agency should continue to be empowered to undertake pilot programmes to ensure a future-proof regulatory ecosystem. Initiatives such as the pilot programme launched in 2022 offering enhanced support to academic and non-profit developers of advanced therapy medicinal products should guide policy-making and update regulatory support.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 35

(35) The Agency’s scientific committees should be ~~able to delegate some of~~supported, for their evaluation duties toby working parties which should be open to experts from the scientific world and appointed for this purpose and by additional experts drawn from the pool of accredited experts, whilst retaining complete responsibility for the scientific opinions issued by them.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 36

(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. Their evaluation will continue to encompass all the necessary expertise for each product as part of the rapporteur teams, with the possibility for CHMP and PRAC to call upon additional scientific experts to provide specific input and advice on specific aspects raised during the evaluation. In addition patients and healthcare professionals will be part of the pool of experts and will also be brought into EMA’s work according to their expertise in a certain disease area. The CHMP and PRAC consists of experts from all Member States while working parties and expert groups consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 38 a (new)

(38 a) For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union, with a view to enabling earlier availability for patients, the Agency should be able to perform a ‘phased review’ of data packages concerning finalised tests and trials before a formal application for marketing authorisation is submitted, to allow a more efficient assessment of medicinal products, while guaranteeing a high level of human health protection.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 51

(51) AGiven that the marketing authorisation holder has to forthwith submit any new data that might impact the benefit-risk balance of its products and given that the Agency has several tools available to continuously monitor the benefits and risks of authorised medicines, such as assessment of PSURs, signal detection and referrals, regulatory action will be taken as needed throughout the lifecycle of the product. Therefore, as a general rule a marketing authorisation should be granted for an unlimited time; however, one renewal may be decided only on justified grounds related to the safety of the medicinal product.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 76

(76) It is considered appropriate to also have the possibility for the Commission to grant temporary emergency marketing authorisations to address public health emergencies. Temporary emergency marketing authorisations may be granted provided that, having regard to the circumstances of the public health emergency, the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent to the fact that additional comprehensive quality, non-clinical, clinical data may still be required. A temporary emergency marketing authorisation should be valid only during the public health emergency. The Commission should be given the possibility to vary, suspend or revoke such marketing authorisations in order to protect public health or when the marketing authorisation holder has not complied with the conditions and obligations set out in the temporary emergency marketing authorisation, or when a standard or conditional marketing authorisation has been granted for the relevant indication.

2023/11/21
Committee: ENVI

(84 a) The Transferable Exclusivity Vouchers (TEV) could be complemented by a procurement mechanism, as outlined in the Council Recommendation on “Stepping up actions to combat AMR in a One Health approach”, providing coordinated financial commitment across the EU and Member States. This would provide the predictability that will encourage comprehensive commercialisation of new priority antimicrobials.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 87 a (new)

(87 a) The European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19, called for an EU Action plan for rare diseases.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 88

(88) Regulation (EC) No 141/2000 of the European Parliament and of the Council55 has proved to be successful in boosting developments of orphan medicinal products in the Union; therefore an action at Union level remains preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Union trade. The Union should not neglect or disregard the success of the Regulation since its entry into force in 2000, and build on its success driving and ensuring a similar degree of innovation under this Regulation. _________________ 55 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 100

(100) Orphan medicinal products addressing a high unmet medical need prevent, diagnose or treat conditions where either no other method of prevention, diagnosis or treatment exists or, if such method already exists, they would bring exceptional therapeutic advancement. In both cases, the criterion of meaningful reduction in disease morbidity or mortality for the relevant patient population should ensure that only most effective medicinal products are covered. The Agency should draw up scientific guidelines on the category of ‘orphan medicinal products addressing a high unmet medical need’.deleted

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 102

(102) In order to incentivise research, innovation and development of orphan medicinal products ~~addressing high unmet needs~~, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; ~~orphan medicinal products addressing high unmet~~designated as a breakthrough orphan medicinal ~~need~~products benefit from the longest market exclusivity, while market exclusivity for well-established use orphan medicinal products, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 129

(129) Scientific and technological progresses in data analytics and data infrastructure are essential for the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data- driven and multiplying the possibilities to access evidence, across the life cycle of a medicinal product. This Regulation recognises the Agency’s experience and capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On thise basis of the totality of evidence made available to the Agency, the Agency should ~~take initiative to~~be able to propose updates to the summary of product characteristics in case new e~~fficacy or safety data~~vidence has an impact on the benefit- risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 132 a (new)

(132 a)To ensure patients’ access to innovative medicines, it is appropriate to establish common rules for the testing and authorisation of innovative medicinal products and innovative technologies related to such products that, due to their exceptional nature or characteristics, are expected to not completely fit the EU medicines regulatory framework.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 132 b (new)

(132 b)Regulatory sandboxes may be set up when it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product, and those characteristics or methods positively and distinctively contribute to the quality, safety or efficacy of the medicinal product or category of products or provide a major advantage contribution to patient access to treatment.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 132 c (new)

(132 c) The objectives of the regulatory sandboxes should be: for the Agency and national competent authorities to increase their understanding of technical and scientific developments, to allow developers in a controlled environment to test and develop innovative medicinal products and related technologies that are not fitting the current regulatory framework, as agreed with the competent authorities, and to identify possible future adaptations of the legal framework.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 133

(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly ~~import~~significant in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. ~~Regulatory sandboxes~~It is important to ensure that SMEs and startups can easily access sandboxes in order to be able to contribute with their knowhow and experience. Regulatory sandboxes are controlled frameworks which, by provideing a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment ~~especial~~particularly in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. They allow the authorities tasked with implementing and enforcing the legislation to exercise on a case-by-case basis and in exceptional circumstances a degree of flexibility in relation to testing innovative technologies, for the benefit of bringing these products to patients without compromising the standards of quality, safety and efficacy. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case-by-case basis when drafting and reviewing legislation.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 134

(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and ~~existing~~current levels of protection need to be respected.

2023/11/21
Committee: ENVI

Proposal for a regulation
Recital 135

(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed and comprehensive plan outlining the ~~particular~~specificities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where ~~appropriat~~suitable, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point 4

(4) ‘orphan medicineal product sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point 7

(7) ‘significant benefit’ means a clinically relevant advantage or a major contribution to patient care of an orphan medicinal product if such an advantage or contribution benefits a ~~substantial~~relevant part of the target population;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point 10

(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which ~~are likely to fall in the scope of this Regulation,~~might be regulated as medicinal products or other categories of products pursuant to a specific plan and for a limited time under regulatory supervision.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)

(11 a) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)

(12 a) ‘supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorization holder or a manufacturer.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1

For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis~~, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union~~ or expected to be of major interest from the point of view of public health, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 4

4. Where appropriate, the application may include an active substance master file certificate or an application for an active substance master file or any other quality master file certificate or application as referred to in Article 25 and Article 26 of [revised Directive 2001/83/EC].

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 2

On the basis of a duly reasoned request, the Committee for Medicinal Products for Human Use may call for the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation to be extended, once for an additional period of 30 days.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 1

When an application is submitted for a marketing authorisation in respect of medicinal products for human use ~~which~~or new therapeutic indications when grouped with an extension of the marketing authorisation, which provide an exceptional therapeutic advancement or are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. ~~The same shall apply for p~~Products referred to in Article 60(2) and article 60 shall qualify for this process by default. The request shall be duly substantiated.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 2

If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 1520 days.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 6 a (new)

Article6a Parallel application (1) During the scientific assessment of an initial marketing authorisation application of a medicinal product by the Agency, the applicant may submit to the Agency a separate parallel application for one or more new indications concerning the same medicinal product. (2) The parallel application shall be assessed by the Agency as a marketing authorisation application in accordance with this Regulation, subject to the following: a) to the extent the Committee for Medicinal Products for Human Use can assess the parallel application within the timeframe applicable to the initial marketing authorisation application, leading to the same outcome for both applications it shall group the applications and issue a single opinion. b) to the extent the said Committee cannot issue an opinion on the parallel application within the timeframe applicable to the initial marketing authorisation application, the parallel application shall be converted to a Type II variation application. c) if the initial marketing authorisation application is withdrawn or receives a negative opinion from the Committee for Medicinal Products for Human Use, the Committee will pursue the assessment of the parallel application as a standalone marketing authorisation application.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 10 – paragraph 2

2. Where within 960 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the Agency, the application shall be considered as withdrawn.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

Within 126 days of receipt of the opinion of the Committee for Medicinal products for Human Use the Commission shall submit to the Standing Committee on Medicinal Products for Human Use referred to in Article 173(1) a draft of the decision on the application.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 2

2. The Commission shall, by means of implementing acts, take a final decision within 126 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173, paragraphs 2 and 3.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 15 – paragraph 1 – point d

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant;deleted

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 15 – paragraph 1 – point d a (new)

(d a) the content or timelines of post- authorisation studies to further clarify environmental risk assessment, as required in Article 20(c), cannot be agreed.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1

The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature. Before the publishment of the assessment report, the Agency shall firstly notify patients´ organisations about the outcomes of the report.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 18 – paragraph 1 – introductory part

1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1

The maintenance of the authorised new therapeutic indication, including when grouped with an extension of the marketing authorisation, and the validity of the marketing authorisation granted in accordance with paragraph 1 shall be linked to the reassessment by the Agency of the conditions referred to in paragraph 1 after two years from the date when the new therapeutic indication, including when grouped with an extension of the marketing authorisation, was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the Agency and specified by the Commission in the marketing authorisation.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 2

This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication, including when grouped with an extension of the marketing authorisation, or renew the marketing authorisation under exceptional circumstances.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1

In duly justified cases, to meet an unmet medical need of patients, as referred to in Article 83(1), point (a) and (2), of [revised Directive 2001/83/EC], a conditional marketing authorisation or a new conditional therapeutic indication ~~to an~~, including when grouped with an extension of existing marketing authorisation authorised under this Regulation may be granted by the Commission to a medicinal product that is likely to address the unmet medical need in accordance with Article 83(1), point (b), of [revised Directive 2001/83/EC], prior to the submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of that medicinal product outweighs the risk inherent in the fact that additional data are still required.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2

In emergency situations, a conditional marketing authorisation or a new conditional therapeutic indication, including when grouped with an extension of the marketing authorisation, referred to in the first subparagraph may be granted also where comprehensive non- clinical or pharmaceutical data have not been supplied.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 2

2. Conditional marketing authorisations or a new conditional therapeutic indication, including when grouped with an extension of the marketing authorisation, referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be able to provide comprehensive data.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 3

3. Conditional marketing authorisations or a new conditional therapeutic indication, including when grouped with an extension of the marketing authorisation, granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 5 a (new)

5 a. The Agency shall lay down criteria for the fulfilment of these conditions and make them publicly available.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 8 – point b

(b) the procedures and requirements for granting a conditional marketing authorisation, for its renewal, and for adding a new conditional therapeutic indication, or extension to an existing marketing authorisation.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 2

2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a group of patients or a single patient with a chronically or seriously debilitating disease or whose disease is considered to be life- threatening, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 3

3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 6

6. The Agency shall keep an up-to- date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a central repository for compassionate use on its website.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 30 – paragraph 1

During a public health emergency, the Commission may, following an application by a developer grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non- clinical, clinical data and environmental data and information.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 30 – paragraph 3

~~An application for a temporary emergency marketing authorisation shall be submitted in accordance with Articles 5 and 6.~~deleted

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 30 – paragraph 3 – subparagraph 1 (new)

Derogations to Articles 5 and 6 of this Regulation may apply in the context of submission of an application for a temporary emergency marketing authorisation.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 31 – paragraph 1 – introductory part

A temporary emergency marketing authorisation or a temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council67 and where the following requirements are met: _________________ 67 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 31 – paragraph 1 – point a

(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation o~~f the medicinal product~~r temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 32 – paragraph 1

1. The Agency shall ensure that the scientific opinion of the Committee for Medicinal Products for Human Use is given to the applicant without undue delay, taking into account, the recommendation of the Emergency Task Force referred to in Article 38(1), second subparagraph. For the purpose of issuing its opinion, the Agency may consider any relevant data on the medicinal product concerned. in addition to the evidence submitted in the applicant’s dossier.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 32 – paragraph 2 – subparagraph 1

The Agency shall review any new evidence provided by the ~~developer~~applicant, the Member States or the Commission, or any other evidence of sufficient quality that comes to its attention in addition to and in the context of evidence submitted by the applicant, in particular evidence that might influence the benefit-risk balance of the medicinal product concerned.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 32 – paragraph 2 – subparagraph 2

TFollowing consultation with the applicant, the Agency shall update its scientific opinion as necessary.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 33 – paragraph 2

2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the Commission shall set specific conditions with respect to the temporary emergency marketing authorisation, in particular the conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices. If necessary, the conditions may specify the batches of the medicinal product concerned by the temporary emergency marketing authorisation, in consultation with the with the applicant or marketing authorisation holder.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 33 – paragraph 4

4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency, in consultation with the marketing authorisation holder.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 34 – paragraph 1

The temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 34 – paragraph 1 a (new)

1a. When the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with first subparagraph of this Article, a transitional period shall be set by the Agency in agreement with the marketing authorisation holder in order to avoid any disruption in supply of the medicinal product concerned.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 35 – paragraph 2 a (new)

2a. Where the Commission adopts any such implementing act, the provisions of Article 34, paragraph 1a shall apply.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 36 – paragraph 2

For the purpose of regulatory data protection, the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, and any subsequent marketing authorisation, as referred to in subparagraph 1, shall be considered as part of the same global marketing authorisation.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 37 – paragraph 1

When the temporary marketing authorisation of a medicinal product is suspended or revoked for reasons other than the safety of the medicinal product, or if that temporary emergency marketing authorisation ceases to be valid, Member States may, in exceptional circumstances, allow for a transitional period, the supply of the medicinal product to patients who are already being treated with it.deleted

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 40 – paragraph 1

1. Following a request by the applicant ~~when applying for a~~for a marketing authorisation, made before that marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product ~~is within its first four~~has at least two years of regulatory data protection remaining.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 42 – paragraph 2

2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if ain normal circumstances, a reasonable request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled, where such request is consistent with the expected needs of the Union market and the non-fulfilment is not due to circumstances beyond the control of the marketing authorisation holder .

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 43 – paragraph 1

This Chapter shall apply ~~until [Note to OP: insert the date of~~from the entry into force of this Regulation. 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 this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 2

The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence, including any additional evidence that may be submitted by the marketing authorisation holders of the medicinal products concerned, make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need. The evaluation shall consider the position of the marketing authorisation holders on the totality of evidence submitted.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 3

The opinion of the Agency shall be made publicly available and the competent authorities of the Member States and the marketing authorisation holders shall be informed.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 56 – paragraph 1

Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, or a new therapeutic indication, including when grouped with an extension of the marketing authorisation, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 58 – paragraph 1 – subparagraph 2

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC] and for medicinal products used with an in vitro diagnostic medical device.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 58 – paragraph 2

2. In the preparation of the scientific advice referred to in paragraph 1 and upon request by undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the Agency may consult experts of the Member States with clinical trial or ~~medical~~ device expertise or the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 58 – paragraph 3

3. In the preparation of the scientific advice referred to in paragraph 1 and in duly justified cases, the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or other ~~public bodies established in the Union~~bodies, as applicable.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 59 – paragraph 2

2. In case of medicinal products ~~involving a~~used with a medical device or an in vitro diagnostic medical device, undertakings or, as relevant, not-for-profit entities may request scientific advice as referred to in Article 58(1) in parallel with the consultation of the expert panels referred to in ~~Article 61(2)~~Regulation (EU) 2017/745 ofr Regulation (EU) 2017/7456.

2023/11/21
Committee: ENVI

1. The Agency ~~may~~shall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products and new indications, including when grouped with an extension of the marketing authorization, that, based on preliminary evidence submitted by the developer fulfil one of the following conditions:

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 60 – paragraph 1 – point b

(b) are orphan medicinal products ~~and are likely to address a high unmet medical need as referred to in Article 70(1)~~;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 60 – paragraph 1 – point c

(c) provide an exceptional therapeutic advancement or are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1

For products under development which may fall within the categories of medicinal products to be authorised by the Union listed in Annex I, a developer or a competent authority of the Member States may submit a duly substantiated request to the Agency for a scientific recommendation with a view to determining on scientific grounds whether the concerned product is potentially a ‘medicinal product’, including an ‘advanced therapy medicinal product’ as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council71 . The Agency may rely on the relevant expertise of working parties and pools of experts, including on advanced therapy medicinal products, when making its recommendation. _________________ 71 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 63 – paragraph 1 – point a

(a) the condition affects not more than ~~five~~5 in 10 000 persons in the Union when the application for an orphan designation is submitted;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 64 – paragraph 1

1. The orphan medicineal product sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – introductory part

The application for the designation of the orphan medicin~~e sponsor~~al product shall be accompanied by the following particulars and documentation:

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1

The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) within 90 days of the receipt of a valid application. Within the timelines for adoption of a decision foreseen in paragraph 3, the Agency shall transmit its scientific conclusions to the applicant. Within 30 days of receipt of the scientific conclusions, the sponsor may submit to the Agency a written request, citing detailed grounds, for a re-examination. Within 30 days following receipt of a request for re-examination, the Agency shall confirm or revise its previous scientific conclusions.Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. If, within the 30-day period referred to in subparagraph 3, the applicant does not request re-examination, the scientific conclusions shall become definitive. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 66 – paragraph 1

1. An orphan designation shall be valid f~~or seven years~~rom the day of the adoption of the decision granting the orphan designation by the Agency. During this period, the orphan medicine sponsor shall be eligible for incentives referred to in Article 68.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 66 – paragraph 2

2. By way of derogation from paragraph 1, on the basis of a justified request of the orphan medicine sponsor, the Agency may extend the validity, where the orphan medicine sponsor can provide evidence that the relevant studies supporting the use of the designated orphan medicinal product in the applied conditions are ongoing and promising with regard to the filing of a future application. Such an extension shall be limited in time, taking into account the expected remaining time needed to file an application for marketing authorisation.deleted

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 66 – paragraph 5

5. At any time, an orphan designation may be withdrawn at the request of the orphan medicine sponsor. The orphan medicine sponsor may provide a reasoned justification for the withdrawal request which shall be made publicly available.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 68 – paragraph 2 – subparagraph 1 (new)

For the purpose of paragraph 2, the definitions set out in Article 58a paragraph 1 of [revised Directive 2001/83/EC] shall apply.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 69 – paragraph 2 – subparagraph 2

Where appropriate, the applicant shall provide relevant evidence to demonstrate that the medicinal product ~~addresses a high unmet~~constitutes a breakthrough orphan medicinal ~~need as specified~~product in accordance with in Article 70(1).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 69 – paragraph 3 – subparagraph 1

The Committee for Medicinal Products for Human Use shall assess whether the medicinal product fulfils the requirements set out in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2). In the situation referred in paragraph 2, subparagraph 2, that Committee shall also assess whether the medicinal product ~~addresses a high unmet~~constitutes a breakthrough orphan medicinal ~~need as specified~~product in accordance with in Article 70(1).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 70 – title

Breakthrough Designated Orphan medicinal products ~~addressing a high unmet medical need~~

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 70 – paragraph 1 – introductory part

1. An orphan medicinal product shall be ~~considered as addressing a high unmet~~designated as a breakthrough orphan medicinal ~~need~~product where it ~~fulfils~~can be demonstrated at the moment of designation that the one of the following requirements are met:

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 70 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such condition orwhere, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancementexists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union, or;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 70 – paragraph 1 – point b

(b) twhere, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product uses a new and unique mechanism of action and the use of the ~~orphan~~ medicinal product results in a meaningful prevention of or reduction in disease morbidity or mortality or a major contribution to patient care for the relevant ~~patient~~ population.

2023/11/21
Committee: ENVI

Tomislav SOKOL, Stelios KYMPOUROPOULOS, Pernille WEISS

Proposal for a regulation
Article 70 – paragraph 2

~~2. A medicinal product for which an application has been submitted in accordance with Article 13 of [revised Directive 2001/83/EC] shall not be considered as addressing a high unmet medical need.~~deleted

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 70 – paragraph 3

3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and the authorities or bodies, as well as the stakeholders such as representatives of patients' organisations in the relevant disease areas, healthcare professionals, orphan medicinal product sponsors, representatives of pharmaceutical industry and other relevant stakeholders referred to in Article 162.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 71 – paragraph 2 – point a

(a) ~~nine~~ten years for orphan medicinal products other than those referred to in points (b) and (c);

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 71 – paragraph 2 – point b

(b) twelven years for breakthrough orphan medicinal products ~~addressing a high unmet medical need~~ as referred to in Article 70;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 71 – paragraph 2 – point c

(c) ~~five~~six years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 71 – paragraph 2 – point c a (new)

(c a) twelve years for orphan medicinal products addressing requirements set in Article 70, paragraph 1 point (a) and (b) in the paediatric population.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 71 – paragraph 3

3. Where a marketing authorisation holder holds more than one orphan marketing authorisations for the same active substance, those authorisations shall ~~not~~ benefit from separate market exclusivity periods~~. The duration of the market exclusivity shall start from the date when the first orphan~~, provided that a market exclusivity period was still in force when the application for marketing authorisation was ~~granted in the Union~~submitted.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1

The periods of market exclusivity referred to in Article 71, paragraph 2, points (a) and (b), shall be prolonged by 12 months, where the orphan marketing authorisation holder can demonstrate that the conditions referred to in Article 81(2), point (a), and Article 82(1) [of revised Directive 2001/83/EC] are fulfilled.deleted

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1

The period of market exclusivity shall be prolonged by an additional 124 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 2

Such a prolongation may be granted twice, if the new therapeutic indications are ~~each time~~ for different orphan conditions.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 72 – paragraph 3

3. ~~The orphan medicinal products which benefit from the prolongat~~Upon request from the applicant, the periond of market exclusivity ~~referred to in the paragraph 2 shall not benefit from the additional period of data protection referred to in Article 81(2), point (d), of [revised Directive 2001/83/EC]~~for orphan medicinal products referred to in Article 71(2), points (a) and (b) shall be prolonged by an additional 24 months where an application for orphan marketing authorisation is submitted in respect of a designated orphan medicinal product and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 72 – paragraph 4 a (new)

4 a. An orphan medicinal product which benefits from the prolongation of market exclusivity as referred to in paragraph 3, shall not benefit from the rewards referred to in Article 86 [of revised Directive 2001/83/EC].

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 72 – paragraph 4 b (new)

4 b. The holder of an orphan marketing authorisation shall be entitled to a total maximum period of 14 years of orphan marketing exclusivity from the time the orphan medicinal product in question first obtains an authorization as defined in Article 69.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 75 – paragraph 1 – point b

(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless ~~whe~~on the ~~product is directed at a molecular target~~basis of existing scientific data, there is medical plausibility that on the ~~basis of existing scientific data, is responsible for~~product, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 75 – paragraph 1 – point c

(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing ~~treatments for paediatric patients~~methods of diagnosis, prevention or treatments for paediatric patients, including when clinical studies are not feasible.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 75 – paragraph 3 a (new)

3 a. In consultation with the Commission and with interested parties, the Agency shall draw up guidelines for the application of this Article.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 76 – paragraph 1

1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation confirmatory of safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 77 – paragraph 1

1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 980 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 81 – paragraph 3

3. The length of the deferral shall be specified in a decision of the Agency and shall ~~not exceed five years~~be justified on scientific and technical grounds or on grounds relating to public health.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 82 – paragraph 1 – subparagraph 1

In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 612 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 2

The applicant shall submit the changes requested within 690 days.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 87 – paragraph 2 a (new)

2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 87 – paragraph 2 b (new)

2 b. Within 30 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re- examination.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 87 – paragraph 2 c (new)

2 c. Within 30 days following receipt of a request for re-examination pursuant to paragraph 4, the Agency shall confirm or revise its previous scientific conclusions. The Agency shall be able to question the applicant directly. The applicant may also offer to be questioned. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 87 – paragraph 2 d (new)

2 d. If, within the 30-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive.

2023/11/21
Committee: ENVI

Sunčana GLAVAK, Tomislav SOKOL

Proposal for a regulation
Article 87 – paragraph 2 e (new)

2 e. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 88 – paragraph 1 a (new)

Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4 could not be completed due to failure of timely completion of pediatric studies, for the product that has already been authorized for use in adults in accordance with the provision of this Regulation, the Agency should consider evidence from the pediatric studies as specified in Article 138, paragraph 1, subparagraph 2, point za a(new)

2023/11/21
Committee: ENVI

Sunčana GLAVAK, Tomislav SOKOL

Proposal for a regulation
Article 91 – paragraph 3 a (new)

3 a. Where a medicinal product is covered by a marketing authorization for adults, and the paediatric authorisation could not be completed due to the inability to timely complete the pediatric clinical studies, instead of granting deferrals, the Agency should consider evidence from the pediatric studies defined in Article 138, paragraph 1, subparagraph 2, point za a(new)

2023/11/21
Committee: ENVI

Sunčana GLAVAK, Tomislav SOKOL

Proposal for a regulation
Article 95 – paragraph 2 a (new)

2 a. Within the European network, the Agency shall, together with the proposed members of the network, develop a platform study concept for paediatric patients. The objectives of the platform study concept are to create active paediatric patients’ master files open for future authorizations of the same molecules or molecules with the same mechanism of action, and/or to share the same pool of patients for joined clinical trials of industry and academia within the same administrative process.

2023/11/21
Committee: ENVI

(a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to such medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 113 – paragraph 2 – subparagraph 1

The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 and other applicable Union legislation under the conditions set out in Article 114.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 113 – paragraph 3

3. The Agency shall monitor the field of emerging medicinal products and ~~may~~shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and ~~may~~shall engage with them in preliminary discussions, where relevant by invoking the mechanism of consultation of Article 162. The Agency may set up consultation mechanism with other Union and non- Union regulatory agencies to facilitate its monitoring. The Agency shall draw up and regularly update a list of emerging medicinal or health products for which a regulatory sandbox may be established.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1

Where the Agency considers it appropriate to set up a regulatory sandbox for ~~medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission~~products which might be regulated as medicinal products (including advanced therapy medicinal products), medical devices, in- vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where relevant after invoking the mechanism of consultation of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 113 – paragraph 5

5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] ~~and~~, Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 113 – paragraph 7 – point c

(c) include as part of the sandbox plan the requirements of this Regulation ~~and of~~, [revised Directive 2001/83/EC], of Regulation (EC) 1394/2007 and of other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 113 – paragraph 9

9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by ~~the~~ adoapti~~on of supplementary conditions~~ng the applicable requirements and conditions laid down in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 114 – paragraph 3

3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation ~~and~~ ,[revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and of other applicable Union legislation. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 1

The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to s~~uspend~~top or restrict their use and inform the Commission in accordance with Article 113(2).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 2

Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without any delay until an effective mitigation takes place.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 116 – paragraph 1 – point d

(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than ~~six~~three months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 117 – paragraph 1

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the ~~market~~Union list of critical medicinal products referred to in Article 131. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by determining medicinal products for which a shortage prevention plan shall be maintained and kept up to date, including due to the lack of availability of alternatives. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 117 – paragraph 2

2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c), patients´ organisations and healthcare professionals and other interested parties shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 119 – paragraph 1 a (new)

1 a. To comply with their obligations, marketing authorisation holders shall have access to all relevant information contained in the repositories system referred to Article 67, paragraph 2, second subparagraph, point (e) for the purpose of fulfilling any obligation arising under [Revised] Directive (…) or this Regulation, including notifying shortages and assessing whether a product was supplied to another Member State than the one where it was placed.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 120 – paragraph 1 a (new)

1 a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information requested in a timely manner to the Agency, the competent authority in a Member State, and the relevant marketing authorisation holder to confirm that the temporary disruption in supply of the product in a Member State was not caused by parallel distribution to another Member State.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)

(b a) establish an accessible and easily understandable system for patient organisations to report shortages of medicinal products;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 122 – paragraph 6

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that~~, where relevant,~~ data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases, ~~without duplication of reporting~~including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of Directive [revised Directive 2001/83/EC], without duplication of reporting for marketing authorisation holders and national competent authorities. The ESMP shall be fully digitalised and automated.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 124 – paragraph 1 a (new)

1 a. The Commission shall be entitled to restrict parallel distribution of medicinal products following their additions to the list of critical shortages of medicinal products in accordance with Article 123, paragraphs 1 and 2.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 124 – paragraph 3

3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and include, to the extent possible, information from other relevant sources and databases identified by the Agency.

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), patients’ organisations, healthcare professionals and marketing authorisation holders ensure the following:

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a

(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities and availability of alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;

2023/11/21
Committee: ENVI

Proposal for a regulation
Article 131 – paragraph 1

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) in addition to marketing authorisation holders, patients´ organisations and other relevant stakeholders. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

2023/11/21
Committee: ENVI