Registration of biologically active additives

Registration of biologically active additives:

Our services for registration and certification of biologically active additives (BAA) in Russia include:

  • Registering biologically active additives of domestic and foreign manufacturers;
  • Providing highly skilled document translation (for foreign manufacturers);
  • Developing specifications and process instructions (for domestic manufacturers);
  • Selecting manufacturing sites (for domestic manufacturers);
  • Arranging for laboratory testing of the BAA before submission for state registration;
  • Providing customs support for samples (for imported products);
  • Arranging for and monitoring the evaluation for state registration;
  • Arranging for and monitoring the evaluation performed by Rospotrebnadzor (the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Russian Federation);
  • Amending the existing expert findings and certificate of state registration.

We offer a comprehensive solution for the registration of biologically active additives to food.

Preliminary dossier evaluation

  • Perform an initial evaluation of the dossier and provide client consultation
  • Determine whether laboratory testing is required prior to applying for marketing authorisation
  • Evaluate the completeness of the materials submitted and their compliance with registering agency requirements
  • Calculate the cost of registration and come to an agreement with the client

Preliminary laboratory testing of the BAA if applicable, as determined in Stage I

  • Execute contracts and applications for the test centre
  • Translate manufacturer documents (for foreign BAAs)
  • Compile the dossier
  • Monitor the evaluation status
  • Submit additional materials and data upon request by the competent authority
  • Obtain the expert findings

Submission of dossier and samples for evaluation

  • Execution of contracts and applications for the test center
  • Translation of documents of the manufacturer
  • Completing of the dossier for submission
  • Control over passing the expert examination
  • Submission of additional materials and data upon request by the competent authority
  • Obtainment of an expert report

Submission of files to Rospotrebnadzor

  • Compile and finalize dossier
  • Execute the application
  • Submit the dossier to Rospotrebnadzor
  • Monitor the evaluation status
  • Submit additional materials and data upon request by Rospotrebnadzor

Completion of the registration procedure, inclusion of the BAA in the state registry

  • Obtain the marketing authorisation certificate and transfer it to the client
  • List of documents and data required for registration of BAAs

If you need any additional information you can write us via our contact form placed below.

Contact us

If you have any questions or would like to contact us for some reason, please, use this form on the right. We do our best to respond as quickly as possible. Please, enter your real telephone number and we will call you back soon. Also, if you would like us to call you back with a certain answer to your question, then please, describe it in detail in this message. We are looking forward to hearing from you!

Contact information

Telephone №1: +7 (495) 120-11-64
Telephone №2: +7 (495) 120-11-59
Telephone №3: +7 (903) 748-60-35 (English – speaking consultant)