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.