Registration of medicinal products and biologically active additives2017-11-08T12:34:23+03:00

Registration of medicinal products and biologically active additives

Registration of medicinal products

The cycle takes around 2.5-3 years and consists of the following steps:

  • Manufacturing site inspection by Minpromtorg (Ministry of Trade and industry, Russia) to get Russian GMP.

  • Checking and translation of the complete dossier.

  • Application to Ministry of Health, Russia for receiving direction to carry out Clinical study by authorized CRO.

  • Submission of Complete dossier (technical documents, administrative documents, Clinical study)

  • Submission of samples, standards, impurities according to FGBU accountability for Pharmexpertize.

  • Receipt of queries from MOH after Pharmexpertise, which should be replied within limited time.

  • Receipt of the registration certificate.

Registration of APIs

The cycle takes around 6-9 months and consists of the following steps:

  • Manufacturing site inspection by Minpromtorg (Ministry of Trade and industry, Russia) to get GMP.

  • Checking and translation of the complete dossier.

  • Submission of Complete dossier (technical documents, administrative documents)

  • Submission of samples, standards, impurities according to FGBU accountability for Pharmexpertize.

  • Receipt of queries from MOH after Pharmexpertise, which should be replied within limited time.

  • Entry into the state register.

Registration of biologically active additives

The cycle takes around 6 months consists of the following steps

  • Preliminary examination of the dossier

  • Conducting preliminary laboratory tests – if necessary

  • Submission of dossiers and samples for examination

  • Submission of dossiers to Rospotrebnadzor

  • Completion of the registration process, entry into the state register

Registration of cosmetics

The cycle takes around 1-2 months consists of the following steps

  • Preliminary examination of the dossier

  • Conducting preliminary laboratory tests – if necessary

  • Submission of dossiers and samples for examination

  • Submission of dossiers to Rospotrebnadzor

  • Completion of the registration process, entry into the state register

Registration of medical devices

The cycle takes around 8-12 months and consists of the following steps:

  • Preliminary examination of the dossier

  • Conducting tests

  • Examination of the dossier by organizations authorized by Roszdravnadzor.

  • Conducting clinical (medical) tests.

  • Entry into the state register, obtaining of the Registration Certificate.

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