CRED ERP 25

Reference medicinal product:

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o Note: The chosen reference medicinal product must be a medicinal product authorised in the Community on the basis of a complete dossier in accordance with the provisions of Article 8 of Directive 2001/83/EC.

• It should be a medicinal product which is or has been authorised in accordance with Community provisions in force for not less than 8 years in the EEA: o Product name, strength(s), pharmaceutical form(s) o Marketing authorisation holder o Date of authorisation (yyyy-mm-dd) o Marketing authorisation granted by a Member State o Community provisions o Member State (EEA) applicable o Marketing authorisation number(s) ▪ Note: This section defines the reference medicinal product chosen for the purposes of establishing the expiry of the data protection period. Full M1, 2.3, 2.4, 2.5, M3, M5 bioequivalence study normally required • Need satisfactory in vitro equivalence data • There are certain circumstances under which it would be possible to avoid conducting bioequivalence studies ( Further reading: check bioequivalence guideline for further information on so-calle d “Biowaivers”) • Consult bioequivalence guideline for study designs Further reading: Guideline on the Investigation of Bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1/ Corr https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence rev1_en.pdf 10(3) “Hybrid” Not a “generic” but still relies partially on a reference product having been approved • Strict definition of “generic” product not met • Where bioavailability studies cannot be used to demonstrate bioequivalence (for example where the new product is supra-bioavailable or for locally applied/locally acting medicinal products)Or applies when changes in active substance, indications, strength, pharmaceutical form, or route of administration are made when compared to the reference medicinal product • Assumes cross-referral to parts of an existing EU product (full) dossier Note: In any event Article 10(3) should not be used as a legal basis for applications for products for which it is possible to demonstrate bioequivalence through bioavailability studies but the applicant failed to submit results of such studies demonstrating bioequivalence. See section 5.3.2.2 of chapter 1 of Volume 2A of NTA). Additional data is therefore needed to justify the specific dosage form, strength, indication • See Annex IV in NTA Chapter 1 on Article 10 /extension applications for guidance on type of data needed. Generic dossier requirements •