What changed between the plenary report and the adopted text

Added:6. The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

Added:For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA to include risk mitigation measures as referred to in paragraph 3. The competent authority shall also request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment. [Am. 132]

Added:7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data and the scientific guidelines as referred to in paragraph 1 of this Article. [Am. 133]

Added:7a. The outcome of the assessment of the ERA, including the data submitted by the marketing authorisation holder, shall be made publicly available by the Agency or, as appropriate, by the competent authority of the Member State. [Am. 134]

Added:7b. When making public the information on the ERA, including the antimicrobial stewardship and access plan referred to in Article 17, the competent authority shall delete any information of a commercially confidential nature. [Am. 135]

Added:Article 23 ERA of medicinal products authorised before 30 October 2005

Added:1. By [OP please insert the date = 3024 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the ECDC, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2. [Am. 136]

Added:This programme shall be made publicly available by the Agency.

Added:2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency shall consult relevant stakeholders, including actors managing residues from medicinal products and their production in the environment and may request from marketing authorisation holders the submission of relevant data or information. [Am. 137]

Added:3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data and a summary of ERA studies and their results as submitted by the marketing authorisation holder shall be made publicly available by the Agency. [Am. 138]

Added:4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals.

Added:Article 24 System of ERA monographs of the ERA data of active substances

Added:1. The Agency shall, in collaboration with the competent authorities of the Member States, set-up an active substance based review system of ERA data (‘ERA monographs’) for authorised medicinal products and publicise relevant information about that system. An ERA monograph shall include a comprehensive set of physiochemical data, fate data and effect data based on an assessment of a competent authority. [Am. 139]

Added:2. The setting-up of the system of ERA monographs shall be based on a risk-based prioritisation of active substances and data requirements. [Am. 140]

Added:3. In the preparation of the ERA monograph referred to in paragraph 1, the Agency may request information, studies and data from competent authorities of the Member States and from marketing authorisation holders.

Added:4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within three years30 months after entering into force of this Directive, while taking into account outcomes from relevant Union initiatives with regard to animal testing. [Am. 141]

Added:5. The Commission is empowered to adopt delegated acts in accordance with Article 215 and based on the results of a proof-of-concept pilot referred to in paragraph 4, to supplement this Directive by specifying the following:

Added:(a) the content and format of ERA monographs;

Added:(b) the procedures for adopting and updating the ERA monographs;

Added:(c) the procedures for submission of information, studies and data referred to in paragraph 3;

Added:(d) the risk-based prioritisation criteria for the selection and prioritisation referred to in paragraph 2;

Added:(e) the use of ERA monographs in the context of new marketing authorisation applications for medicinal products to support their ERA.

Added:Article 25 Active substance master file certificate

Added:1. Marketing authorisation applicants may, instead of submitting the relevant data on a chemical active substance of a medicinal product required in accordance with Annex II, rely on an active substance master file, an active substance master file certificate granted by the Agency in accordance with this Article (‘active substance master file certificate’) or a certificate confirming that the quality of the active substance concerned is suitably controlled by the relevant monograph of the European Pharmacopeia.

Added:Marketing authorisation applicants may only rely on an active substance master file if no certificate exists on the same active substance master file.

Added:2. An active substance master file certificate may be granted by the Agency in cases where the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by an active substance master file certificate.

Added:In order to obtain an active substance master file certificate, an application shall be submitted to the Agency. The applicant for an active substance master file certificate shall demonstrate that the active substance concerned is not already covered by a monograph of the European Pharmacopeia or an active substance master file certificate. The Agency shall examine the application and, in case of a positive outcome, shall grant the certificate that shall be valid throughout the Union. In case of centralised marketing authorisations, the application for an active substance master file certificate may be submitted as part of the marketing authorisation application for the corresponding medicinal product.

Added:The Agency shall establish a repository of active substance master files, their assessments reports and their certificates and ensure that personal data is protected. The Agency shall ensure that the competent authorities of the Member State have access to this repository.

Added:3. The active substance master file and the active substance master file certificate shall cover all the information required in Annex II on the active substance.

Added:4. The active substance master file certificate holder shall be the manufacturer of the active substance.

Added:5. The active substance master file certificate holder shall keep the active substance master file up to date with scientific and technological progress and introduce the changes required to ensure that the active substance is manufactured and controlled in accordance with generally accepted scientific methods.

Added:6. If requested by the Agency, the manufacturer of the substance for which an application for an active substance master file certificate has been submitted or the active substance master file certificate holder shall undergo an inspection to verify the information contained in the application or the active substance master file or their compliance with good manufacturing practices for active substances referred to in Article 160.

Added:If the manufacturer of an active substance refuses to undergo such an inspection, the Agency may suspend or terminate the application for an active substance master file certificate.

Added:7. If the active substance master file certificate holder does not fulfil the obligations set out in the paragraphs 5 and 6, the Agency may suspend or withdraw the certificate and, the competent authorities of the Member States may suspend or revoke the marketing authorisation of a medicinal product relying on that certificate or take measures to prohibit the supply of the medicinal product relying on that certificate.

Added:8. The marketing authorisation holder of the medicinal product granted on the basis of an active substance master file certificate remains responsible and liable for that medicinal product.

Added:9. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying, the following:

Added:(a) the rules governing the content and format of the application for an active substance master file certificate;

Added:(b) the rules for the examination of an application for an active substance master file certificate and for the granting of the certificate;

Added:(c) the rules for making publicly available of active substance master file certificates;

Added:(d) the rules for introducing changes to the active substance master file and the active substance master file certificate;

Added:(e) the rules on access for competent authorities of the Member States to the active substance master file and its assessment report;

Added:(f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on an active substance master file certificate to the active substance master file and to the assessment report.

Added:Article 26 Additional quality master files

Added:1. Marketing authorisation applicants may, instead of submitting the relevant data on an active substance other than a chemical active substance, or on other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, rely on an additional quality master file, an additional quality master file certificate granted by the Agency in accordance with this Article (‘additional quality master file certificate’), or a certificate confirming that the quality of that substance is suitably controlled by the relevant monograph of the European Pharmacopeia.

Added:Marketing authorisation applicants may only rely on an additional quality master file certificate if no certificate exists on the same additional quality master file.

Added:2. Article 25, paragraphs 1 to 5, 7 and 8 shall also apply mutadis mutandis to additional quality master file certification.

Added:3. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying:

Added:(a) the rules governing the content and format of the application for an active substance master file certificate;

Added:(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance, preparation or other material present or used in the manufacture of a medicinal product, including cell therapies and gene therapies; [Am. 142]

Added:(c) the rules for the examination of applications for making publicly available of additional quality master file certificates;

Added:(d) the rules for introducing changes to the additional quality master file and the certificate;

Added:(e) the rules on access for competent authorities of the Member State to the additional quality master file and its assessment report;

Added:(f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on an additional quality master file certificate to the additional quality master file and to the assessment report.

Added:4. If requested by the Agency, the manufacturer of a substance present or used in the manufacture of a medicinal product for which an application for an additional quality master file certificate has been submitted or the additional quality master file certificate holder shall undergo an inspection to verify the information contained in the application or the quality master file.

Added:If the manufacturer of this substance refuses to undergo such an inspection, the Agency may suspend or terminate the application for the additional quality master file certificate.

Added:Article 26a Additional platform technology master files

Added:1. Marketing authorisation applicants may, instead of submitting the relevant data related to a platform technology, rely on an additional platform technology master file or an additional platform technology master file certificate granted by the Agency in accordance with this Article (‘additional platform technology master file certificate’).

Added:2. Article 25(1) to (5), (7) and (8) shall also apply mutatis mutandis to additional platform technology master file certificates.

Added:3. To adequately describe the platform technology master file, appropriate information as laid down in scientific guidelines published by the Agency shall be provided.

Added:4. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying: