Instructive for the Modification of the Marketing Authorization for Pharmaceuticals Upon Expiration of a Patent

The National Agency for Health Inspection, Regulation and Monitoring (ARCSA), has issued an instructive setting out a procedure relating to the modification of a marketing authorization upon expiration of a patent, which will apply to all owners of marketing authorizations of pharmaceuticals registered in Ecuador whose patent has expired. The provisions are as follows:

  • ARCSA will notify owners of marketing authorizations for pharmaceuticals once the patent expires, so that they may proceed with an application for modification of a marketing authorization for the products in question, notwithstanding the responsibility of the owner of the registration to comply with that provided for by the relevant regulations, in particular the marketing of the pharmaceuticals must also conform to that provided by the “Law of Production, Import, Marketing and Distribution of Generic Medicines for Human Use”, which states that upon re-labelling, the label must contain the International Nonproprietary Name with priority given to the words ‘Medicamento de Referencia’ (Reference Medication).
  • The denomination ‘reference medication’ does not prevent the product from being marketed with a trademark.

In addition, ARCSA will authorize the exhaustion of the existing labels and medications already in the market for which the marketing authorization is being modified. The new procedure will become requirement as from 19th September 2017.

16th May 2017