Changes from plenary report to adopted text

Added(c) monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks impact on the benefit-risk balance.

Added2. The Pharmacovigilance Risk Assessment Committee shall perform the initial analysis and prioritisation of signals of new risks or risks that have changed or changes to the benefit-risk balance. Where it considers that follow-up action may be necessary, the assessment of those signals and agreement on any subsequent action concerning the marketing authorisation shall be conducted in a timescale commensurate with the extent and seriousness of the issue. Where appropriate, the assessment of those signals may be included in a pending assessment of a periodic safety update report or a pending procedure in accordance with Articles 95 and 114 of [revised Directive 2001/83/EC] or Article 55 of this Regulation.

Added3. The Agency and competent authorities of the Member States and the marketing authorisation holder shall inform each other in the event of new risks or risks that have changed or changes to the benefit-risk balance being detected.

AddedArticle 108 Non-interventional post-authorisation safety studies

Added1. For non-interventional post-authorisation safety studies concerning medicinal products for human use authorised in accordance with this Regulation which have been imposed in accordance with Articles 13 and 20, the procedure provided for in Article 117, paragraphs 3 to 7, Articles 118, 119, 120 and 121(1) of [revised Directive 2001/83/EC] shall apply.

Added2. Where, in accordance with the procedure referred to in paragraph 1, the Pharmacovigilance Risk Assessment Committee issues recommendations for the variation, suspension or revocation of the marketing authorisation, the Committee on Medicinal Products for Human Use shall adopt an opinion taking into account the recommendation, and the Commission shall adopt a decision in accordance with Article 13.

AddedWhere the opinion of the Committee for Medicinal Products for Human Use differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use shall attach to its opinion a detailed explanation of the scientific grounds for the differences, together with the recommendation.

AddedArticle 109 Exchange of information with other organisations

Added1. The Agency shall collaborate with the World Health Organization in matters of pharmacovigilance and shall take the necessary steps to submit to it, promptly, appropriate and adequate information regarding the measures taken in the Union which could have a bearing on public health protection in third countries.

AddedThe Agency shall make available promptly all suspected adverse reaction reports occurring in the Union to the World Health Organization.

Added2. The Agency and the European Monitoring Centre forUnion Drugs and Drug AddictionAgency shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs. [Am. 237]

AddedArticle 110 International collaboration

AddedAt the request of the Commission, the Agency shall participate in collaboration with the Member States in international harmonisation and standardisation of technical measures in relation to pharmacovigilance.

AddedArticle 111 Cooperation with Member States

AddedThe Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. [Am. 238]

AddedArticle 112 Reports on pharmacovigilance tasks

AddedThe Agency shall perform regular independent audits of its pharmacovigilance tasks and report the results to its Management Board on a 2-yearly basis. The results shall be subsequently published.

AddedCHAPTER IX REGULATORY SANDBOX

AddedArticle 113 Regulatory sandbox

Added1. The Commission may set up on a case-by-case basis a regulatory sandbox pursuant to a specific sandbox plan, based on a recommendation of the Agency and pursuant to the procedure set out in paragraphs 4 to 7, where all the following conditions are met: [Am. 239]

Added(a) 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;

Added(b) the characteristics or methods referred to in point (a) 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.

Added2. 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 under the conditions set out in Article 114.

AddedA regulatory sandbox shall take effect under direct supervision of the competent authorities of the Member States concerned with a view to ensuring compliance with the requirements of this Regulation and, where relevant, other Union and Member State legislation concerned by the sandbox. Any violation of the conditions set out in the decision referred to in paragraph 6 and the identification of any risks to health and to environment shall be immediately notified to the Commission and to the Agency.

Added3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions, where appropriate referring to the consultation mechanism provided for in Article 162. [Am. 240]

Added4. 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 but for which there is an absence of existing adapted rules for development and authorisation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. [Am. 241]

AddedThe Agency shall not recommend to set up a regulatory sandbox for a medicinal product that is already advanced in its development programme.

Added5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, with patients, academia, health technology assessment bodies, healthcare professionals or developers. 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 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. [Am. 242]

Added6. The Commission shall, by means of implementing acts, take adopt delegated acts in accordance with Article 175 to supplement this Regulation by taking a decision on the set up of a regulatory sandbox taking into account the recommendation of the Agency and the sandbox plan pursuant to paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). [Am. 243]

Added7. Decisions establishing a regulatory sandbox under paragraph 5 shall be limited in time and shall set out detailed conditions for its implementation. These Decisions shall:

Added(a) include the proposed sandbox plan;

Added(b) include the duration of the regulatory sandbox and its expiry;

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

Added8. The Commission may, by means of implementing acts, suspend or revoke a regulatory sandbox at any time. in any of the following cases:

Added(a) the requirements and conditions laid down in paragraphs 6 and 7 are no longer met;

Added(b) it is appropriate to protect public health. or the environment. [Am. 244]

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

AddedWhere the Agency receives information that one of the cases referred to in the first subparagraph may be fulfilled, it shall inform the Commission accordingly.

Added9. 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 adoption of supplementary conditions, 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). The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by, on the basis of duly justified reasoning and evidence from the Agency, prolonging the duration of a regulatory sandbox. [Am. 245]

Added10. This Article shall not exclude the setting up of time limited pilot projects to test different ways of implementing the applicable legislation.

AddedArticle 114 Products developed under a sandbox

Added1. When authorising a clinical trial application for products covered by a regulatory sandbox, Member States shall take the sandbox plan referred to in Article 113(1) into consideration.

Added2. A medicinal product developed as part of a regulatory sandbox may be placed on the market only when authorised in accordance with this Regulation. The initial validity of such authorisation shall not exceed the duration of the regulatory sandbox. The authorisation may, upon a justified recommendation by the Agency, be prolonged at the request of the marketing authorisation holder. [Am. 246]

Added3. 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]. Any derogation from the requirements in context of the sandbox shall ensure that the level of patient safety and protection of public health and ethical principles are upheld. 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. [Am. 247]

Added4. For medicinal products developed as part of a regulatory sandbox for which a marketing authorisation has been granted in accordance with paragraph 2 and where appropriate paragraph 3, the summary of product characteristics and the package leaflet shall indicate that the medicinal product has been developed as part of a regulatory sandbox.

Added5. Without prejudice to Article 195 of [revised Directive 2001/83/EC], the Commission shall suspend a marketing authorisation granted in accordance with paragraph 2, where the regulatory sandbox has been suspended or revoked in accordance with Article 113(7).

Added6. The Commission shall immediately vary the marketing authorisation to take account of the mitigation measures taken in accordance with Article 115.

AddedArticle 115 General sandbox provisions

Added1. 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 suspend or restrict their use and inform the Commission in accordance with Article 113(2).

AddedWhere such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place. If no effective mitigation plan can be provided, the Agency shall end the sandbox without undue delay. [Am. 248]

Added2. Participants in the regulatory sandbox, in particular the marketing authorisation holder of the medicinal product concerned, shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result from the testing taking place in the sandbox. They shall inform the Agency without undue delay of any information which might entail the amendment of the regulatory sandbox or concerns the quality, safety or efficacy of products developed as part of a regulatory sandbox.

Added3. The modalities and the conditions of the operation of the regulatory sandboxes, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Added4. The Agency with input from Member States shall submit annual reports to the Commission on the results from the implementation of a regulatory sandbox, including a breakdown on the number of sandboxes granted, trends on medicinal products eligible for a regulatory sandbox, good practices, difficulties encountered, lessons learnt, reflections on possible future adaptations to the regulatory framework and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legal acts supervised within the sandbox. These reports as well as lay summaries shall be made publicly available by the Commission. [Am. 249]

Added5. The Commission shall review the reports and put forward, as appropriate, legislative proposals with a view to update the regulatory framework referred to in Article 113(2) or delegated acts in accordance with Article 28 of [revised Directive 2001/83/EC].

AddedCHAPTER X AVAILABILITY AND SECURITY OF SUPPLY OF MEDICINAL PRODUCTS

AddedSection 1 Monitoring and management of shortages and critical shortages

AddedArticle 116 Marketing authorisation holder notifications

Added1. The marketing authorisation holder of a medicinal product in possession of a centralised marketing authorisation or a national marketing authorisation (‘the marketing authorisation holder’) shall notify and explain the reasons to the competent authority of the Member State where the medicinal product has been placed on the market and, in addition, the Agency for a medicinal product covered by a centralised marketing authorisation (these are referred to in this Chapter as ‘the competent authority concerned’) of the following: [Am. 250]

Added(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

Added(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;