CRED ERP 25

All marketing authorisations in the EU are based on Directive 2001/83/EC and Regulation (EC) No 726/2004 Article 8(3) of Directive 2001/83/EC requires that the results of pharmaceutical and pre-clinical tests and clinical trials be submitted as part of the Marketing Authorisation Application. In some situations, the full data required in a new application may not be required, i.e., it may be possible to rely on data presented in another dossier or published data. However, data required to support the quality of the product is always required (Module 3 per Article 8(3) Directive 2001/83/EC). In other words, all headings of the dossier under the CTD must be satisfied in some way (by inclusion of original data, published literature or by cross-referral to an existing approved dossier).

Article 10 of Directive 2001/83/EC describes the basis for approval without the provision of the complete information required by Article 8.

Traditional herbal medicinal products are covered in Chapter 2a Directive 2001/83/EC.

Changes to existing products Where an MA Holder is considering making a change to an existing product (such as addition of an indication, change in strength or dosage form) there are two options that should be explored; Extension or Variation • Changes to an existing product by the MA holder are normally considered variations o See latest guidance on classification of variations https://eur

lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013XC0802(04) and https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008R1234 20210513 *

• Annex to Regulation 1234/2008/EC defines when the change is significant enough as to require a new application rather than a variation o (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008R1234 20210513) o See guideline on Categorisation of extensions versus variations applications (version July 019) https://ec.europa.eu/health/document/download/0616d3ab 90f4-4494-8575-9199e8efb78f_en o See also CMDh document MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures * NB: The European Commission published at the beginning of June 2025 the final draft Variations Guidelines: https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy europe_en#implementation Extension applications • Although assessed as a new application it is still considered to be part of same overall Global MA (may have a different licence number) for market exclusivity purposes. • This can be a separate full stand-alone application but would still not gain additional exclusivity. (Notice to Applicants [NTA] Procedure Vol 2A Ch1 7.2). • The legal basis of an application for a line extension should have the same legal basis as the originator product of which it is a line extension (see CMDh document MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures)