CRED ERP 25

European Regulatory Procedures: Pre-Read Legal basis, application types, non-NCEs and borderline products

The objective of this pre-read summary is to enable you to become familiar with the key facts relating to the different types of legal basis and application types for Marketing Authorisation Applications in the EU. During the course itself, expert speakers will give a brief outline of these the different application types and when they are most commonly used. In order for you to get the most out of the course and the presentations, a certain amount of background reading and study on your part is required. The presenters will assume that you have read the pre- read materials and that you are at least familiar with the following topics:

1. Legal basis 2. Generics/hybrids/line extensions 3. Biosimilars 4. Bibliographic/well-established use/combination products 5. Borderline products 6. Herbals 7. Questions for the TOPRA presenters

1. Legal basis

The legal requirements and the procedures for making an application for a marketing authorisation are established by Directive 2001/83/EC and subsequent Regulation (EC) No 726/2004.

Regulatory strategy (and different requirements for applications) is defined by type of product and legal basis for submission of your EU Marketing Authorisation Application in accordance with the various articles of Directive 2001/83/EC: • Full application - Article 8(3) - (comprised of originator data or originator data plus published scientific literature [ “full, mixed”]) ➢ Generic, hybrid or similar biological applications - Article 10 • Well-established use application - Article 10a • Fixed combination application - Article 10b • Informed consent application - Article 10c • An abridged (so called generic) application referring to a reference medicinal product – Article 10(1) • An abridged, so-called ‘hybrid’ application - Article 10(3 (comprised of own data of for the hybrid product plus a cross-reference to parts of an existing dossier of a reference medicinal product (also known as hybrid generic) • A ‘similar’ biological medicinal product - Article 10(4)

Further explanation and clarification on the legal basis can be found in chapter 1 of Volume 2A of the Notice to applicants, reference link below.

It is important, however, that the requirements and procedures are not confused with the presentation of the application dossier, guidance on which is given in "The Rules Governing Medicinal Products in the European Union, Volume 2B Notice to Applicants: Presentation and content of the dossier". Further reading: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap1_en.pdf https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-2_en#volume-2b---presentation and-content-of-the-dossier