Changes from plenary report to adopted text

Added(13) Where relevant, evidence from other sources of clinical data (non-interventional clinical studies, registries).

Added(14) A summary of the applicant’s pharmacovigilance system which shall include the following elements:

Added(a) proof that the applicant has at their disposal a qualified person responsible for pharmacovigilance,

Added(b) the Member States in which the qualified person resides and carries out their tasks,

Added(c) the contact details of the qualified person,

Added(d) a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Chapter VI,

Added(e) a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.

Added(15) The risk management plan describing the risk management system which the applicant will introduce for the medicinal product concerned, together with a summary thereof.

Added(16) A statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Regulation (EU) No 536/2014.

Added(17) A summary of product characteristics in accordance with Article 62, a mock-up of the outer packaging, containing the details provided for in Annex IV, and of the immediate packaging of the medicinal product, containing the details provided for in Article 66, together with a package leaflet in accordance with Article 64.

Added(18) A document showing that the manufacturer is authorised in their own country to produce medicinal products.

Added(19) Copies of the following:

Added(a) any marketing authorisation, obtained in another Member State or in a third country, to place the medicinal product on the market, a summary of the safety data including the data contained in the periodic safety update reports, where available, and suspected adverse reactions reports, together with a list of those Member States in which an application for marketing authorisation submitted in accordance with this Directive is under examination;

Added(b) the summary of product characteristics proposed by the applicant in accordance with Article 62 or approved by the competent authorities of the Member State in accordance with Article 43 and the package leaflet proposed in accordance with Article 64 or approved by the competent authorities of the Member State in accordance with Article 76;

Added(c) details of any decision to refuse marketing authorisation, whether in the Union or in a third country, and the reasons for such a decision.

Added(20) A copy of any designation of the medicinal product as an orphan medicinal product as defined in Article 63 of [revised Regulation (EC) No 726/2004], accompanied by a copy of the relevant Agency opinion.

Added(21) Where the application concerns an antimicrobial medicinal product, the application shall also contain:

Addeda) an antimicrobial stewardship and access plan which shall in particular outline: [Am. 328]

Added(i) information about risk mitigation measures to limit antimicrobial resistance development related to the use, prescription and administration of the medicinal product;

Added(ii) how the marketing authorisation holder intends to monitor and report to the competent authority the resistance to the antimicrobial medicinal product.

Added(iia) information about measures for a strategy to promote access, including proposed production chain capacity; [Am. 329]

Added(iib) information about measures to ensure marketing approvals are received for key territories in a timely manner; and [Am. 330]

Added(iic) information about measures to monitor effectiveness of stewardship and access. [Am. 331]

Addedb) a description of the special information requirements outlined in Article 58

Addedc) details on the pack size which shall correspond to the usual posology and duration of treatment.

Added(22) Where an application concerns the marketing authorisation to market a radionuclide generator, in addition to the requirements set out in Articles 6 and 9, it shall also contain:

Added(a) a general description of the system together with a detailed description of the components of the system that may affect the composition or quality of the daughter nucleid preparation; and

Added(b) qualitative and quantitative particulars of the eluate or the sublimate.

Added(23) Good manufacturing practices certificates.

AddedAnnex II

AddedANALYTICAL, PHARMACOTOXICOLOGICAL AND CLININCAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS

AddedTABLE OF CONTENTS

AddedPart I: Standardised marketing authorisation dossier requirements

Added1. Module 1: Administrative information

Added1.1. Table of contents

Added1.2. Application form

Added1.3. Summary of product characteristics, labelling and package leaflet

Added1.3.1. Summary of product characteristics

Added1.3.2. Labelling and package leaflet

Added1.3.3. Mock-ups and specimens

Added1.3.4. Summaries of product characteristics already approved in the Member States

Added1.4. Information about the experts

Added1.5. Specific requirements for different types of applications

Added1.6. Environmental risk assessment

Added2. Module 2: Summaries

Added2.1. Overall table of contents

Added2.2. Introduction

Added2.3. Quality overall summary

Added2.4. Non-clinical overview

Added2.5. Clinical overview

Added2.6. Non-clinical summary

Added2.7. Clinical Summary

Added3. Module 3: Chemical, pharmaceutical and biological information for medicinal products containing chemical and/or biological active substances

Added3.1. Format and presentation

Added3.2. Content: basic principles and requirements

Added3.2.1. Active substance(s)

Added3.2.1.1. General information and information related to the starting and raw materials

Added3.2.1.2. Manufacturing process of the active substance(s)

Added3.2.1.3. Characterisation of the active substance(s)

Added3.2.1.4. Control of active substance(s)