Registration of pharmaceutical substances, inclusion of pharmaceutical substances into the State Register of Medicines
Pursuant to part 4 article 45 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of Medicines”, “pharmaceutical substances included into the State register of medicines are used during manufacture of medicines”. By virtue of article 33 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of Medicines” two ways for inclusion of pharmaceutical substances into the State register of medicines are prescribed:
1) For pharmaceutical substances as part of a medicine – within the scope of state registration of the medicine.
In this case a pharmaceutical substance will be used only for manufacture of the given medicine. The expertise of quality of a pharmaceutical substance shall be conducted within the framework of registration of finished dosage form.
2) For pharmaceutical substances not used in the manufacture of medicines – within the scope of a separate registration process.
In this case, a pharmaceutical substance can be used as part of medicines at any pharmaceutical productions. The expertise of quality of a pharmaceutical substance shall be conducted in accordance with article 34 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of Medicines”.
The document evidencing the inclusion of a pharmaceutical substance into the State register of medicines is a Resolution on inclusion of a pharmaceutical substance into the State register of medicines.
The stages of registration of a pharmaceutical substance not used in manufacture of the finished dosage form
I stage – expertise of quality of a pharmaceutical substance (quality control of a pharmaceutical substance at the authorized Laboratory center and approval of regulatory documentation);
II stage – Decision-making by RF Ministry of Healthcare on inclusion of a pharmaceutical substance into the State register of medicines.
LLC “Medcertificate” provides the following services on inclusion of a pharmaceutical substance into the State register of medicines.
- customer consultations on the matters of inclusion of a pharmaceutical substance into the State register of medicines;
- preparation of a plan for inclusion of a pharmaceutical substance into the State register of medicines and a list of necessary documents;
- adaptation of documentation submitted by foreign partners to the requirements of the Russian Federation;
- development of regulatory documentation for a pharmaceutical substance;
- formation of a registration dossier;
- submission of the registration dossier to the authorized federal executive authority in charge of state registration of medicines (Ministry of Healthcare of the Russian Federation);
- support of the process of including a pharmaceutical substance into the State register of medicines;
- obtaining permits, resolutions and official requests from the authorized federal executive authority in charge of state registration of medicines;
- preparation of additional materials in accordance with the requests of the authorized federal executive authority in charge of state registration of medicines;
- obtaining a Resolution on inclusion of a pharmaceutical substance and approved documentation (RI, packaging layouts) for a pharmaceutical substance.