Changes from plenary report to adopted text

Added(ca) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’), supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department. [Am. 82]

RemovedArticle 81 – paragraph 2 – subparagraph 1 – point b: (b) 12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

Added6. Medicinal products referred to in paragraph 5, point (a)points (a) and (b), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven days, or when duly justified based on the stability of the medicinal product within a different time limit. [Am. 83]

RemovedArticle 81 – paragraph 2 – subparagraph 1 – point c a (new): (ca) six months, where the marketing authorisation holder demonstrates that a significant share of research and development, including preclinical and clinical, related to the medicinal product has been done within the Union and at least in part in collaboration with public entities, including university hospital institutes, centres of excellence or bioclusters located in the Union.

Added7. Member States shall take the necessary measures to develop the production and use of medicinal products derived from substances of human origin coming from voluntary unpaid donations in accordance with Regulation (EU) 2024/1938. [Am. 84]

RemovedArticle 81 – paragraph 2 – subparagraph 1 – point d: deleted

Added8. This Directive and all Regulations referred to therein shall be without prejudice to the application of national legislation prohibiting or restricting the use of any specific type of substance of human origin or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these animal cells or substances of human origin, on grounds not dealt with in the aforementioned Union law. The Member States shall communicate the national legislation concerned to the Commission.

RemovedArticle 81 – paragraph 2 – subparagraph 3: deleted

Added9. The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions.

RemovedArticle 81 – paragraph 2 – subparagraph 3 a (new): By ... [12 months from the date of entry into force of this Directive], the Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by setting out the procedural aspects and criteria related to the first subparagraph, point (ca), of this paragraph.

Added10. This Directive shall not affect the application of national legislation prohibiting or restricting the following:

RemovedArticle 81 – paragraph 3 a (new): 3a. The regulatory protection referred to in paragraphs 1 and 2 shall not exceed eight years and six months.

Added(a) the sale, supply or use of medicinal products as contraceptives or abortifacients; [Am. 85]

RemovedArticle 82: deleted

Added(b) the use of any specific type of substance of human origin or animal cells, on grounds not dealt with in the aforementioned Union law;

RemovedArticle 83 – 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 and the stakeholders referred to in Article 162(1) and (2), respectively, of [revised Regulation (EC) No 726/2004].

Added(c) the sale, supply or use of medicinal products containing, consisting of or derived from these animal cells or substances of human origin, on grounds not dealt with in Union law.

RemovedArticle 85 – paragraph 1 – introductory part: Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when necessary studies, trials and other activities are conducted for the purpose of:

AddedArticle 2 Advanced therapy medicinal products prepared under hospital exemption

RemovedArticle 85 – paragraph 1 – point a – introductory part: deleted

Added1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner and, where relevant, a hospital pharmacist. To satisfy the criteria of 'non-routine basis', the exemption shall be made only in order to comply with an individual medical prescription for a custom-made product forto meet the special need of an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). [Am. 86]

RemovedArticle 85 – paragraph 1 – point a – point i: (i) obtaining a marketing authorisation and subsequent variations;

Added2. The manufacturing of an advanced therapy medicinal product prepared under hospital exemption shall require an approval by the competent authority of the Member State (‘hospital exemption approval’). Member States shall notify any such approval, as well as subsequent changes, to the Agency.

RemovedArticle 85 – paragraph 1 – point a – point ii: (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

AddedThe application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The application shall include evidence on quality, safety and expected efficacy of the advanced therapy medicinal products prepared under hospital exemption. [Am. 87]

RemovedArticle 85 – paragraph 1 – point a – point iii: (iii) obtaining pricing and reimbursement approval; and

Added3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirementsgood pharmacy preparation practices that are adapted to hospital processes while still equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. This shall include site inspections as well as traceability and pharmacovigilance plans and the evaluation of the preclinical and clinical data generated by the applicant. [Am. 88]

RemovedArticle 85 – paragraph 1 – point a – point iii a (new): (iiia) the subsequent practical requirements associated with such activities.

Added4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption, as well as any relevant data from patient follow-up for a sufficient period of time after the administration of the advanced therapy medicinal product, is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The data shall be collected and reported in a structured and standardised way that enables robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Competent authorities shall ensure that scientific and regulatory advice is provided to non-profit and academic institutions in order to ensure appropriate reporting mechanisms. [Am. 89]

RemovedArticle 85 – paragraph 1 – point b: The activities conducted exclusively for the purposes set out in the first paragraph, shall cover as relevant the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Added5. If a hospital exemption approval is revoked due to safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

RemovedArticle 85 a (new): Article 85a / Non-interference of intellectual property rights / 1. Member States shall consider the procedures and decisions referred to in Article 85 as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. / 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions referred to in Article 85. / 3. Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Added6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain via regular updates a repository of that data as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, which shall be updated regularly. The repository shall be publicly available except for personal data and commercially confidential information. [Am. 90]

RemovedArticle 86 a (new): Article 86a / Reporting on access to medicinal products / The Commission, in collaboration with the Member States, shall develop indicators to measure access to medicinal products within the Union. Those indicators shall be evidence-based, measurable, and regularly reviewed to reflect the evolving healthcare landscape within the Union. / The Commission shall publish a report assessing access to medicinal products and barriers to improving such access in each Member State and at aggregated Union level. The report shall be publically available. / Based on the report, the Commission shall create a dedicated website with easily accessible information on the access indicators and access to medicinal products in the Union, intended for the general public and relevant stakeholders. / The report shall be drawn up for the first time by [the date of the end of the second year from the date of entry into force of this Directive] and every five years thereafter.

Added7. The Commission shall adopt implementing acts to specify the following:

RemovedArticle 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1: (c) to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment or public health, including antimicrobial resistance, due to an authorised medicinal product, or related active substance; where the post-authorisation environmental risk assessment study concerns an antimicrobial, it shall include relevant and comparable data on the volume of sales and the use per types of antimicrobial medicinal products; the Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report; the Agency shall take into account those data when adopting any relevant guidelines and recommendations.

Added(a) details of the application for the approval of hospital exemption referred to in paragraph 1, second subparagraph, including the evidence on quality, safety and efficacy of the advance therapy medicinal products prepared under hospital exemption for the approval and the subsequent changes; [Am. 91]

RemovedArticle 87 – paragraph 1 – subparagraph 2: The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study. Information on imposed post-authorisation studies shall be noted in the product’s European Public Assessment Report and a database of the competent authority.

Added(b) the format for collection and reporting of data referred to in paragraph 4;

RemovedArticle 92 – paragraph 3: 3. The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the competent authority. Such procedures may also include updates by the marketing authorisation holder of their information held in a database. Where deemed justified by the Agency, accelerated assessment procedures shall also be envisaged for variations which are of major interest from the point of view of public health.

Added(c) the modalities for the exchange of knowledge between hospital exemption approval holders within the same Member State or different Member States;

RemovedArticle 94 – paragraph 1: 1. On the basis of relevant paediatric clinical studies received in accordance with Article 45(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council76 , the competent authorities of the Member States may, following a consultation of the marketing authorisation holder, vary the marketing authorisation of the medicinal product concerned accordingly and update the summary of product characteristics and package leaflet of the medicinal product concerned. The competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned.

Added(ca) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause. [Am. 92]

RemovedArticle 96 – paragraph 1 – subparagraph 1: Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in the Union pharmacovigilance activities including the pharmacovigilance of the post-authorisation safety and efficacy long-term studies in children, including where relevant data from the off-label use of the product.

Added(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis. [Am. 93]

RemovedArticle 97 – paragraph 1 – point e a (new): (ea) facilitate the protection of patients in relation to adverse events through the development and implementation of plans for safe administration and handling of medicinal products, which may include the use of digital medication safety systems in hospitals and ambulatory care settings.

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

RemovedArticle 102 – paragraph 1 – point b a (new): (ba) the outcome of the assessment of the ERA, including the data submitted by the marketing authorisation holder, in accordance with Article 22(7a) and Article 29(4a);

AddedBy ... [24 months from the date of entry into force of this Directive], the Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by establishing:

RemovedArticle 102 – paragraph 1 – point d a (new): (da) where relevant, information related to antimicrobials, in accordance with Article 17(2) and Article 29(4a);

Added(a) details of the application for the approval of hospital exemption referred to in paragraph 1, second subparagraph, including the evidence on quality, safety and efficacy of the advance therapy medicinal products prepared under hospital exemption for the approval and the subsequent changes;

RemovedArticle 102 – paragraph 1 – point d b (new): (db) where relevant, the awareness card with information on antimicrobial resistance and the appropriate use and disposal of antimicrobials;

Added(b) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis. [Am. 94]

RemovedArticle 102 – paragraph 1 – point d c (new): (dc) periodic safety update reports;

Added8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The report shall be made publicly available. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter. [Am. 95]

RemovedArticle 102 – paragraph 1 – point d d (new): (dd) information on the shortage status of medicinal products as referred to in Article 121(1), point (b), of [revised Regulation (EC) No 726/2004];

Added8a. By way of derogation from paragraph 1, Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in justified cases of medical need and in the absence of other solutions for the individual patient. A second medical practitioner and a hospital pharmacist in the receiving Member State shall be designated for the exclusive professional responsibility of the use and collection of follow-up data for the advanced therapy medicinal product. Information about the cross-border exchange shall be submitted to the competent authorities of both Member States, and shall be shared in the public repository referred to in paragraph 6 by the competent authority of the Member State of origin of the advanced therapy medicinal product. [Am. 96]

RemovedArticle 105 – paragraph 2: 2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members, or healthcare professionals.

AddedArticle 3 Exceptions under certain circumstances

Change 2

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