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According to the legislative acts adopted in the Russian Federation, only drugs authorized for appropriate use on the territory of our country are subject to human use. In accordance with the Federal Law dd. 12.04.2010 No. 61-FZ "On Medicine Circulation", obtaining of marketing authorization is compulsory for:
- all medicinal products subject to first launch into circulation in the Russian Federation;
- medicinal products registered earlier, but produced in other dosage forms in accordance with the list of dosage forms names, in a new dosage with its clinical significance and effectiveness proven;
- new combinations of previously registered drugs.
According to the above-mentioned document, the state registration of medicinal products is carried out by the relevant authorized federal executive body – by the Ministry of Health of the Russian Federation, on the basis of a package of documents, i.e. registration dossier, as well as application for state registration of the medicinal product, within a period not exceeding one hundred and sixty business days from the date of the relevant application.
Thus, it is possible to single out the following key points for the registration of a medicinal product:
pplications for state registration of a medicinal product
registration dossier for a medicinal product, which must be submitted in the form of a general technical document in accordance with the Federal Law No. 61 dd. 12.04.2010.
when state registration of generic medicines it is allowed to include a review of scientific works on the results of preclinical trials of the reference medicinal product in the dossier instead of "Report of the developer on the results of its own preclinical trials of medicinal products" and to deliver the "Report on the results of bioequivalence studies of the generic medicinal product" instead of the drug clinical trials.
Our services include
- Consultation on all matters related to the registration of medicines;
- Organization, conduct and thorough control at all stages of dossier formation, including during pre-clinical and clinical trials of the product; Practical implementation of comparative dissolution kinetics test;
- Control over the process of preliminary registration expert evaluation of medicines quality, conducted on the basis of independent laboratories;
- Preparation of a review of scientific papers on the results of preclinical trials of the reference drug;
- Formation of a report on the results of bioequivalence studies of the original and generic drugs;
- Correct writing and formation of the registration dossier;
- Assistance in submitting the necessary package of documents to the registering authority;
- Making adjustments to the registration documents and / or marketing authorizations upon request;
- Participation in the procedure for obtaining approval documentation, decisions and formal requests, as well as preparation of additional materials attached to the requests;
- Assistance in the development of patient information leaflets;
- Obtaining a marketing authorization and approved documents for a medicinal product;
- Post-authorization monitoring programs and pharmacovigilance for the required time after drug authorization. The procedure is primarily aimed at clarifying the "benefit-risk" ratio from the use of drugs that have undergone clinical trials;
- Correction of normative documents and manuals on human use as necessary in connection with changes in the requirements of legislative acts and other documentation.
The specialists of our company are ready to assist at any stage of the registration dossier formation.