CRED ERP 25

2. Definition of a “generic”

Article 10(1) states: “ By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community .” Reference Medicinal Product A reference medicinal product is a product that has been approved on basis submission of a complete dossier as follows: • A product approved with a full Article 8 approval (could be a line extension) or 10a (well established use), 10b (fixed combination product), or 10c (informed consent) as all are considered “complete dossiers” • You will need to identify the product used as reference for any bioequivalence studies in support of a generic application A generic product Will have: • The same active substance (qualitative and quantitative composition) as the reference product • Note: salts, esters, isomers must be considered as the same active substance as the reference medicinal product unless they differ significantly in properties with regard to safety and/or efficacy (article 10(2) (b) of Directive 2001/83/EC • Same pharmaceutical form as the reference product • Demonstrable bioequivalence to the reference product Exclusivity (data exclusivity and marketing protection) refers to periods of time granted to the originator of a product for exclusive rights to market the product before generic competition may be introduced and data exclusivity (8 years before any generic application can be submitted). • Exclusivity periods (10 years for orphan medicinal products, 8+2, 8+2+1) vary and depend on when the originator was first submitted/approved (see NTA Vol 2A Ch1 6.1.2) • Concept of the “Global marketing authorisation” – subsequent variations, strengths, extensions for the original active ingredient do not confer addition to exclusivity period. (NTA Vol 2A Ch1 6.1.4) The implication of data exclusivity is that one cannot file a Generic/hybrid/biosimilar application during the data exclusivityperiod either to RMS or CMS; • Summary (Protection periods after 8 year + 2 years + 1 year) • Data Exclusivity – cannot submit before expiry of data exclusivity period, i.e. 8 years for abridged applications of non-orphan medicinal products and 10 years for abridged applications of orphan medicinal products • Market protection – cannot place on market before expiry of market protection period. • Concept of “global marketing authorisation” • Further reading (see NTA Section 6 of Chapter 1) • See also Case Studies, Points for Consideration issued after the course If it is not a generic product by the above definition it may be a: • Hybrid • Bbiological medicine similar to a reference biological product, “biosimilar” • New fixed combination Exclusivity •

For a generic application, you will need to identify the reference product for exclusivity Look at MAA form section 1.4.2