FAQ (Frequently Asked Questions)

You ask, we answer

Is it possible to return state fee?

It is possible, the return of the state fee is regulated by Order of the Health Ministry of Russia № 1059 from September 20, 2011 “On organization of the Ministry of Health and Social Development of the Russian Federation to return the state fee overpaid to the federal budget for acts related to the implementation of state registration of medicinal products for medical use”.

In the registration dossier for the medicinal product the documents on the substance are included. Will the substance be included in the State Register?

For including the substance to SRMP when registering the medicinal product it is required to pay state fee of 100 000 rubles.

Validity of our medicinal product RC ended two months ago. Is it possible to confirm the state registration of the medicinal product?

In case of cancellation of registration of the medicinal product, the procedure for confirmation of registration is not conducted, you must apply for registration of the medicinal product.

How many series of the medicinal product are necessary to submit to the examination of quality?

For examination of quality the sample of a medicinal product (1 series) is submitted and, if necessary, the sample(s) of pharmaceutical substance(s) used in the batch production of the medicinal product, from which the sample is selected in sufficient quantity for examining the quality on indications provided by the decision of the Health Ministry of Russia in 3 replications. Along with the samples certificates of analysis (analysis passports) are presented for the series of the medicinal product and a series of substance, from which the medicinal product is manufactured.

We are going to register the generic in Russia; what documents should be put in the dossier to confirm the 20-year use in the Russian Federation?

To confirm the medical use term in the registration dossier of a medicinal product authorized for medical use in the Russian Federation for more than twenty years, put a copy of the orders of the USSR “ON PERMIT OF APPLICATION TO MEDICAL USE OF NEW MEDICINAL PRODUCTS” or copies of the instructions with marks of approval.

We received the registration certificate to the medicinal product. Do I need now to pass the preliminary control and, if so, what is the procedure for its conduct?

In the Federal Law № 61-FZ “On circulation of medicinal products” the term “preliminary control” is not defined. It is not required to held preliminary control.

We received a decision about the direction of preparation to the examination of quality. Do we have to submit the samples of the medicinal product with the columns and reagents?

Under Part 5 of Article 23 of the Federal Law № 61-FZ “On the circulation of medicinal products”, “... the applicant shall submit to the expert agency for quality assessment of medicinal product samples of the medicinal product for medical use, produced in accordance with the requirements of experimental-industrial and (or) industrial regulations approved by the head of the manufacturer of medicinal products, as well as in appropriate cases of sample of the pharmaceutical substance, the test strain of microorganisms, cell cultures, samples of substances used for quality control of the medicinal product by comparing them with the investigational medicinal product in the quantities needed for playback the quality control methods”. At the request of the applicant the following may be additionally submitted: drawings of UV, IR spectra and typical chromatograms (using methods of HPLC, GC), as well as columns for HPLC and GC, reagents rarely used in the pharmacopoeia analysis, adapters for inhalers and other materials.

Do I have to specify the color codes on packs layouts?

Federal Law № 61-FZ “On circulation of medicinal products” does not establish standards and requirements for coding and notation of colors on the packaging layouts for medicinal products.