Bill on homologation of drug registrations ready to be debated in the Assembly
8 febrero 2022


On February 8, the plenary of the Legislative Assembly received from the International Relations Committee the file 22280 on the homologation of sanitary registrations of foods coming from countries that are part of the Organization for Economic Cooperation and Development (OECD). This means that the text can now be considered by the Board of Directors of the Legislative Branch to eventually include it in the agenda of the sessions and begin its discussion in the first debate. It covers any type of medicine. This will depend on the political will and the agreements that the deputies may reach.

To achieve this objective, the text includes the following proposals:

  • The process of homologation of sanitary registrations will be carried out through the official digital platform Regístrelo or any other subsequently implemented by the Ministry of Health.
  • Private companies will have to submit the following documents in Spanish to request the homologation:
  • Proof of payment corresponding to the fee established by regulation to request the procedure.
  • Copy of the regulatory technical requirements established for each type of product of health interest whose homologation is total. In the case of partial homologation, copy of the requirements to be homologated and the presentation of those to be evaluated by the Ministry of Health.
  • Certification or copy certified by notary public of the sanitary registration issued by the governing health authority of the country of origin in which it is indicated that the medicine, supplement or food is registered or notified and the effective date of such registration or notification.
  • The Ministry of Health shall give priority to each application for homologation that complies with the above mentioned requirements.
  • The validity of the approved sanitary registrations will run from the date on which the approval is approved until the expiration date of the registration granted by the sanitary authority of the country of origin of the product, as long as it does not exceed five years.
  • If no expiration date is indicated in the registration being approved, the approval will be considered valid for a period of 5 years after the date of approval by the Ministry of Health.