The European Commission has published its position on the “handling of duplicate marketing authorization applications (MAAs),” explaining the circumstances in which duplicate MAAs can be submitted for the same product. The document notes that duplicates are on the increase “as the use of the centralized procedure rises.”
In general, only one MAA can be granted to an applicant for a specific medicinal product under Article 82(1) of EU Regulation No. 726/2004. However, there are valid reasons for submitting duplicate MAAs, including public health considerations related to the availability of medicines and co-marketing arrangements.
The EC document noted that duplicate applications will be assessed on a case-by-case basis, and provides definitions of the scope of Article 82(1).
Examples of applications falling under the scope of Article 82(1) – provided the medicines do not differ significantly in safety and efficacy – include the following:
● The active substance is a different salt
● The medicinal product contains different
● The medicine is made at a different manufacturer or manufacturing site
● Differences in the data submitted in connection with the MAA, and
● An application has “less indications or pharmaceutical forms” than the original MAA.
Case examples are provided for products that propose using alternative excipients.