Registration of biologically active additives (BAA)

Home Registration of pharmaceuticals

Рисунок13.pngBiologically active additives (BAA) are a combination of natural or nature-identical biologically active substances intended for direct intake with meals or addition to food to enrich the diet with individual nutrition and biologically active substances and their complexes.


For successful organization and support of biologically active additives registration, we provide the following services:

  • Full-range services in registration of biologically active additives of foreign manufacture.
  • Arrangement of laboratory tests for BAA before application for the state registration.
  • Arrangement and monitoring of BAA examination for the purpose of the state registration.
  • Arrangement and monitoring of examination of BAA at Federal Service for Consumer Rights Protection and Human Welfare (Rospotrebnadzor).
  • Introduction of changes in the existing expert report and state registration certificate.

The registration procedure for biologically active additives (BAA) is carried out based on the regulatory and legal framework of the Customs Union.

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Registration workflow

Preliminary examination of the dossier

  • The initial examination of the dossier, consultation for the customer.
  • Determination if laboratory tests shall be conducted.
  • Evaluation of completeness of the submitted materials and their compliance with the requirements of the registering authorities.
  • Translation and notarization of documents.
  • Completing of dossier

Submission of dossier and samples to preliminary examination

  • Contracting, preparation of documents for the testing center.
  • Laboratory tests of BAA
  • Submission of additional materials and data if required by the authorised body.
  • Support in process of examination
  • Obtaining the expert report.

Submission of the dossier to the monitoring authority, getting the certificate

  • Submission of the dossier to the Federal Service for Consumer Rights Protection and Human Welfare (Rospotrebnadzor of RF).
  • Support in process of examination.
  • Submission of additional materials and data if required by the Rospotrebnadzor.
  • Receipt of the State Registration Certificate, its delivery to the Customer.