By Supreme Decree N°011-2023-SA, on 17 May 2023, the regulation that establishes the requirements for the registration and re-registration of biological products that have not been obtained by biotechnological procedures and that contain certain substances ("Regulation") was published.

The following points are relevant to this regulation:

  1. The documents to apply for the sanitary registration of these products must comply with the recommendations of the World Health Organization (WHO), the European Medicines Agency (EMA), the Canadian Food and Health Products Agency, the United States Food and Drug Administration (US FDA) and/or other regulatory agencies of high health surveillance countries.

  2. Those products that opt for similarity are governed by the respective standard, and those that do not opt for similarity are governed by the provisions of the Regulation.

  3. Products that have a registration in force at the date of the Regulation's entry into force and that have not opted for the similarity route must continue to submit the Risk Management Plan until 18 May 2024. Failure to submit it will result in the suspension of the respective registration and/or registration certificate.

  4. Exempt from the presentation of the Risk Management Plan are those products that have a current registration or are in the process of re-registration at the date of the Regulation's entry into force.

  5. Until the corresponding regulations have entered into force, the stability studies of the active ingredient (API) and finished product, as well as the description of the components of the container-closure system, must be submitted according to the recommendations indicated in the Regulation .

The Regulation will enter into force on 18 November 2023.

Se puede revisar la norma completa aquí.

We hope that this information will be of relevance to you and your company. If you require any further information, please do not hesitate to contact us.