CRED ERP 25

Quick Reference Guide to Legal Basis

Background:

Types of secondary legislation

• Regulation – Binding to all Member States, no National changes, deviations, or differing local transposition allowed. • Directive – Results binding but method of implementation is up to each Member State via transposition into National law. • Decision – Implementing acts or decisions which are binding upon those individual Member States or a subject for which being addressed. • Guidelines – Interpretation of requirements, recommended but not binding. Helps to explain the rules as set out in legislation.

Legal Basis:

Full application - Article 8(3)

•

• Generic, hybrid or similar biological applications - Article 10 o Well-established use application - Article 10a o Fixed combination application - Article 10b o Informed consent application - Article 10c o

A ‘generic’ of a reference medicinal product – Article 10(1) o A so-called ‘hybrid’ of a reference medicinal product – Article 10(3) o A ‘similar’ biological medicinal product of a biological reference product – Article 10(4)

References & Further Reading:

• Volume 2A Procedures for marketing authorisation Chapter 1 Marketing Authorisation July 2019. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol- 2/vol2a_chap1_en.pdf • Legal basis for all types of application is set out in Directive 2001/83/EC (link to Directive in next bullet point) and in Regulation (EC) No 726/2004, version M6 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol- 1/reg_2004_726/reg_2004_726_en.pdf

• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use; consolidated version with amendments https://eur lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF