Registration of Medicinal Products, Health Products and Food Supplements

Registration of a new medicinal product is the first step in the process of launching it onto the pharmaceutical market of the Russian Federation.

The registration of medicinal products in the Russian Federation is regulated by Federal Law No. 61-FZ “On circulation of medicinal products” of 12.04.2010 and the following four amendments to it: No. 192-FZ of 27.07.2010, No. 271-FZ of 11.10.2010, No. 313-FZ of 29.11.2010, No. 409-FZ of 06.12.2011. At the end of last years the following Federal Law was passed:

No. 429-FZ «On amendments to Federal Law «On circulation of medicinal products» of 22 December 2014. Some of the amendments that it introduces came into force on 1 July 2015, some - on 1 January 2016 and some more than a year later, i.e. on 1 January 2017.

When you contact our specialists, you will receive expert advice and assistance in the process of preparing documents and going through the procedure of state registration.

We render our services until the moment of receipt of Marketing Authorization for Russian and foreign medicinal products of a wide range of applications and origin. We also carry out the following:

Code 01

Registration of medicinal products

Details go to the page

Code 04

Registration of Food Supplements

Details go to the page

Code 05

Consultations on the preparation of Marketing Authorization File

Code 06

Translation and notarization of documents

Code 07

Preparation of mock-up of primary and secondary packaging

Our specialists not only assist with the standard registration procedure, but also render services associated with making amendments to and confirmation of the state registration of medicinal products

Many years of experience have allowed our specialists to develop an algorithm for solving problems that arise at all the stages of paperwork and registration.

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Procedure of registration of medicinal products

Category 1

Categories of medicinal products that are subject to state registration:

Brand-name Medicinal Products
Generic Medicinal Products
Effective combinations of medicinal products that have been previously registered
Already registered medicinal products the formulation and dosage of which have been changed

Medicinal products that have been manufactured by private entrepreneurs or pharmacy organizations in accordance with the respective master formula and in compliance with all the requirements of medical organizations
Starting materials of herbal origin
Medicinal products that have been purchased outside the territory of the Russian Federation, however, are intended for personal use

Category 2

Medicinal products that are not subject to state registration:

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Stages
of Registration

The procedure of registration of foreign and Russian medicinal products is the same.

he procedure of registration consists of 4 successive stages:

Registration
of medicinal
products

Preparation of Marketing Authorization file, including the documents required for the start of clinical trials and submission of the file with the RF Ministry of Health.

Receipt of
approval to conduct
clinical
trials

Receipt of approval to conduct clinical trials and their conduct in the RF.

Evaluation of the quality of the medicinal product Preparation of Marketing

Authorization file, including the documents required for the start of clinical trials and submission of the file with the RF Ministry of Health.

The third stage could be roughly divided into two sub-stages:

01 \

Quality control of the product in the laboratory of the Scientific Center for Expert Evaluation of Medicinal Products Federal State Budgetary Institution and approval of Regulatory Document;

02 \

Evaluation of expected risk-benefit ratio and approval of Instruction on medical application of medicinal products.

Making a decision by the RF Ministry of Health to register the medicinal product

Making a decision by the RF Ministry of Health to register the medicinal product, its inclusion into the RF State Register of Medicinal Products and issue of Marketing Authorization.

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Timelines for
registration

According to Law No. 61-FZ «On circulation of medicinal products», the period of registration is 210 working days. This period does not include the time required for the performance of clinical trials.

210

days

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Procedure of registration of Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients may be released (registered) in the territory of the RF in two ways

Category 1

Registration as part of the registration of the finished dosage form for which this Active Pharmaceutical Ingredient will be used

If the manufacturer supplies the Active Pharmaceutical Ingredient only to some particular plant, information is provided as part of the registration of the finished dosage form and evaluation of the quality of the Active Pharmaceutical Ingredient is carried out. In this case, the Active Pharmaceutical Ingredient will be used only for the product for which the evaluation was performed.

If the manufacturer has not decided yet to which plant they will supply the products or are planning to expand the presence in the sales market, they are entitled to submit documents for the registration of the Active Pharmaceutical Ingredient, which is not used in the production of medicinal products.

The Active Pharmaceutical Ingredient will be included into the RF State Register of Medicinal Products under a separate number.

Category 2

Registration of Active Pharmaceutical Ingredients, which are not used in the production of medicinal products

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Stages of
Registration

The registration of Active Pharmaceutical Ingredients, which are not used in the production of medicinal products, consists of two stages:

Evaluation of the quality of the Active Pharmaceutical Ingredient (quality control in the Laboratory and approval of the Regulatory Document)

Inclusion of the Active Pharmaceutical Ingredient into the RF State Register of Medicinal Products

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Timelines
for registration

The period of registration of the Active Pharmaceutical Ingredient, which is not used in the production of medicinal products :
5-7 months.

5-7

months

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FOOD SUPPLEMENTS: REGISTRATION, REQUIREMENTS, SAFETY

According to the effective legislation of the Russian Federation, Food Supplements are subject to mandatory state registration. On 28 May 2010, the Commission of the Customs Union approved the list of goods subject to mandatory state registration by Decision No. 299, and the "Unified List of Goods" came into force on 01 July 2010.

If your company has decided to manufacture or sell Food Supplements, it is important to obtain a Certificate of State Registration that would confirm the clearance of the product for production (for Russian products), sale, import and use in the territory of the Russian Federation on a timely basis.

In which cases a violation of the current legislation occurs: if Food Supplements were imported into the territory of the Customs Union without the appropriate preparation of the necessary regulatory documentation, if they were sold without obtaining a certificate of state registration, the respective company is subject to severe sanctions. All of the above mentioned aspects are strictly monitored by a number of authorized organizations.

The Certificate of State Registration is an official document issued by the bodies of the Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being (Rospotrebnadzor) and confirms the compliance of products with sanitary-epidemiological and hygienic requirements imposed on controlled goods. The procedure of state registration of products is mandatory for the goods included in the respective list, but its stages require certain experience and knowledge.

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Registration of Food Supplements
in Russia

The following three documents are required for the registration of Food Supplements:

Certificate of
State Registration within the framework of the Customs Union

Declaration of
Conformity

This is not currently mandatory.

Certificate of Quality from the manufacturer

The obligation to issue a Certificate of Quality was canceled according to the letter of Rospotrebnadzor No. 01/330-12-32 "On canceling the obligation to issue a certificate of quality and safety of food products” of from 19.01.2012.

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