Medications – mc-pharm.com

State registration of medicines

Pursuant to part 1 article 13 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of Medicines”, “medicines shall be introduced into the civil turnover across the territory of the Russian Federation if they are registered by the relevant authorized federal executive authority”.

The Ministry of Healthcare of RF serves as an authorized federal executive authority governing the procedure of registration of medicines. The Department for state regulation of circulation of medicines within RF Ministry of Healthcare deals with the registration of new and circulation of already registered medicines.

The following categories of medicines are subject to state registration:

1) original medicines;

2) reproduced medicines;

3) new combinations of previously registered medicines;

4) medicines registered earlier but manufactured in other dosage forms, in new dosage.

The information on a registered medicine, including a pharmaceutical substance, which is part of the medicine, shall be included into the State register of medicines, and a Registration certificate on the medicine and Resolution on the inclusion of a pharmaceutical substance into the State register of medicines shall be issued to the applicant of state registration.

Pursuant to article 28 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of Medicines”, “a registration certificate on the medicine with the indication of dosage forms and dosages shall be issued for an indefinite period of time, except for a registration certificate on the medicine issued for a validity term of five years, for the newly registered medicines in the Russian Federation”.

Upon expiry of five years an indefinite registration certificate on the medicine shall be issued on condition of confirmation of its state registration.

The procedure of registration of medicines consists of several basic stages:

I stage. Preparation of documents for formation of a registration dossier, including documents required for obtaining a permit for conducting clinical research of a medicine, submission of a registration dossier in RF Ministry of Healthcare.

II stage. Obtaining a permit for conducting clinical research (for medicines permitted for medical application across the territory of the Russian Federation less than 20 years), conduct of clinical research.

III stage. Expertise of quality of a medicine and expertise of the expected benefit to potential risk of application of the medicine performed following clinical research of the medicine:

– Medicine quality control at the authorized Laboratory center and approval of the regulatory instrument;

– Expertise of correlation expected benefit to potential risk of application and approval of the Instruction on medical application of the medicine.

IV stage. Decision-making by RF Ministry of Healthcare on inclusion of the medicine into the State register of medicines and execution of a registration certificate.

LLC “Medcertificate” provides the following services on registration of medicines:

customer consultations on the matters related to registration of medicines;
preparation of a plan on registration and list of necessary documents;
adaptation of documentation submitted by foreign partners to the requirements of the Russian Federation;
development of regulatory documentation on medicines;
development of instructions on medical application of medicines;
preparation of layouts of primary and secondary packaging;
elaboration of analysis methodologies;
development of medicine composition and manufacturing technology;
formation of a registration dossier;
submission of a registration dossier to the authorized federal executive authority in charge of state registration of medicines (Ministry of Healthcare of the Russian Federation);
organization and conduct of preclinical research;
organization and conduct of clinical research;
organization and conduct of preclinical research;
organization and conduct of bioequivalence research;
organization and conduct of research of comparative antimicrobial activity of antibiotics;
organization and conduct of test of comparative dissolution kinetics;
support of registration process;
obtaining permit documents, 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 Registration certificate and approved documentation (regulatory instrument, instruction on medical application, packaging layouts) for the medicine.
Introduction of amendments into the documents contained in the registration dossier for the registered medicine.

Pursuant to part 1 article 30 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of medicines”, “for the purposes of introducing amendments into the documents contained in the registration dossier for the registered medicine for medical application the applicant shall submit to the authorized federal executive authority an application for introduction of such amendments, in the form set by the authorized federal executive authority and the attached amendments hereto, into the said documents as well as documents verifying the necessity of introducing such amendments”.

The document verifying the introduction of amendments into the documents contained in the registration dossier for the registered medicine is a Resolution on introduction of amendments into the documents contained in the registration dossier for the registered medicine.

Part 2 article 30 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of medicines” provides for several ways of introducing amendments into the documents contained in the registration dossier for the registered medicine:

1) along with conducting expertise of medicines with regard to expertise of the quality of medicine;

2) along with conducting expertise of medicines with regard to expertise of correlation expected benefit to potential risk of application of medicine for medical application;

3) along with conducting expertise of medicines with regard to expertise of the quality of medicine and expertise of correlation expected benefit to potential risk of application of medicine for medical application;

4) without conduct of expertise of medicines.

The amendments requiring expertise of medicines:

in case of introducing amendments to the instruction on application of medicine in respect of the information stated in sub-clauses “g” – “p”, “h” clause 16 part 3 article 18 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of Medicines”;
in case of introducing amendments to the composition of medicine for medical application;
in case of changing the place of manufacture of medicine for medical application;
in case of changing the medicine’s quality indicators for medical application and (or) quality control methods for medical application;
in case of changing the shelf life of medicine for medical application.

The procedure for introducing amendments to the documents contained in the registration dossier for the registered medicine consists of several basic stages:

I stage. Preparation of documents, formation of a package of documents.

II stage. Submission to the Department for state regulation of circulation of medicines within RF Ministry of Healthcare of an application for introducing amendments to the documents contained in the registration dossier for the registered medicine and formed package of documents.

III stage. Obtaining a Resolution on forwarding a task for conducting expertise of medicine to the expert institution.

IV stage. Conducting expertise of medicine.

V stage. Resolutions on introduction of amendments to the documents contained in the registration dossier for the registered medicine.

LLC “Medcertificate” provides the following services on introduction of amendments to the documents contained in the registration dossier for the registered medicine:

customer consultations on the matters related to introduction of amendments to the documents contained in the registration dossier for the registered medicine;
preparation of a plan for introducing amendments to the documents contained in the registration dossier for the registered medicine and a list of necessary documents;
adaptation of the documentation submitted by foreign partners to the requirements of the Russian Federation;
development of draft regulatory instruments (statements of amendments to regulatory documentation) for medicines with due regard to introduced amendments;
development of instructions on medical application of medicines (statements of amendments to the instruction on medical application) with due regard to introduced amendments;
preparation of layouts of primary and secondary packaging with due regard to introduced amendments;
formation of a package of documents for introduction of amendments to the documents contained in the registration dossier for the registered medicine;
submission of a package of documents to the authorized federal executive authority dealing with state registration of medicines (Ministry of Healthcare of the Russian Federation);
support of the process of introducing amendments to the documents contained in the registration dossier for the registered medicine;
receipt of permits, resolutions and official requests of the authorized federal executive authority in charge of introducing amendments to the documents contained in the registration dossier for the registered medicine;
preparation of additional materials in accordance with the requests of the authorized federal executive authority in charge of introducing amendments to the documents contained in the registration dossier for the registered medicine;
receipt of a Resolution on introduction of amendments to the documents contained in the registration dossier for the registered medicine and approved statements of amendments to RI, instructions on medical application, packaging layouts with due regard to the introduced amendments.

The verification of the state registration of medicines

Pursuant to article 28 of the Federal Law of the Russian Federation dated April 12, 2010 No.61-FZ “On Circulation of medicines”, “a registration certificate on the medicine with indication of dosage forms and dosages shall be issued for an indefinite period of time, except for a registration certificate on the medicine issued for a validity term of five years, for the newly registered medicines in the Russian Federation”.

Upon expiry of five years an indefinite registration certificate on the medicine shall be issued on condition of confirmation of its state registration.

The procedure of verification of state registration of medicines consists of several basic stages:

I stage. Preparation of documents, formation of a registration dossier.

II stage. Submission to the Department for state regulation of circulation of medicines within RF Ministry of Healthcare dealing with state registration of medicines of applications for verification of state registration of medicine as well as the formed registration dossier for the medicine.

III stage. Obtaining a resolution for conducting expertise of correlation expected benefit to potential risk of application of medicine as well as expertise of the quality of medicine conducted in case of introducing amendments to the regulatory documentation or a regulatory instrument.

IV stage. Conducting expertise of medicines with regard to expertise of correlation expected benefit to potential risk of application of medicine and expertise of the quality of medicine, in case of introducing amendments to the regulatory documentation or a regulatory instrument.

V stage. Resolution on verification of state registration of medicine.

LLC “Medcertificate” provides the following services on verification of state registration of medicines:

customer consultations on the matters related to verification of state registration of medicines;
preparation of a plan for verification of registration 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 medicines;
development of instructions on medical application of medicines;
preparation of layouts of primary and secondary packaging;
formation of a registration dossier;
submission of a registration dossier to the authorized federal executive authority dealing with state registration of medicines (Ministry of Healthcare of the Russian Federation);
support of the state registration verification process;
receipt of permits, resolutions and official requests from the authorized federal executive authorities dealing with the verification of state registration of medicines;
preparation of additional materials in accordance with the requests of the authorized federal executive authority dealing with the verification of state registration of medicines;
receipt of an indefinite Registration certificate and approved documentation (RI, instruction on medical application, packaging layouts) for medicine.