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Main  >  News  >  The President of the Russian Federation signed a number of laws in the field of drug circulation

The President of the Russian Federation signed a number of laws in the field of drug circulation

12/29/2019 | drug interchangeability, drug provision, drug circulation

On December 27, 2019, Vladimir Putin signed a number of federal laws in the field of the circulation of medicines and medical devices. All documents were published on December 28 on the official Internet portal of legal information.

Federal Law of December 27, 2019 No. 462-ФЗ “On Amending the Federal Law“ On the Circulation of Medicines ”and the Federal Law“ On Amending the Federal Law “On the Circulation of Medicines”

Federal law postpones the entry into force of the obligation for drug manufacturers to carry out their mandatory labeling - from January 1, 2020 to July 1, 2020. Persons engaged in the production, storage, import into the Russian Federation, dispensing, selling, transferring, using and disposing of drugs will have to ensure that information on drugs is entered into the system for monitoring their movement from July 1. It is envisaged that drugs for patients with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, drugs for those who have undergone organ and (or) tissue transplantation before December 31, 2019, and also other medicines produced before July 1, 2020, are subject to storage, transportation and sale without labeling until the expiration date.

Legal grounds are also established to exclude re-registration of pharmaceutical substances that are part of a medicinal product for medical use, in case when information about the pharmaceutical substance is already contained in the state register of medicines.
Federal law comes into force from the date of its official publication.

Federal Law of December 27, 2019 No. 475-ФЗ “On Amending the Federal Law“ On the Circulation of Medicines ”and the Federal Law“ On Amending the Federal Law “On the Circulation of Medicines”

The law establishes a new procedure for the interchangeability of drugs. Interchangeability will be determined within the framework of one international non-proprietary (or chemical, or grouping) name of the drug by the authorized federal executive body (Ministry of Health of Russia) based on the conclusion of a commission of experts of the relevant expert institution, which will be guided by the criteria (characteristics) established by the Federal Law.

The procedure for the implementation of regional state control over the use of prices for drugs included in the list of vital and essential drugs is being clarified. Such control will be carried out not only in relation to wholesale organizations, pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, but also in relation to medical organizations (their separate divisions) engaged in the sale of medicines.

In order to guarantee the rights of patients to receive unregistered medications necessary for life, containing narcotic drugs or psychotropic substances, the Federal Law establishes that such medications can be imported into the Russian Federation if there is a decision of the medical committee of the medical organization about inefficiency or the impossibility of using a particular patient with other registered drugs and the need for import of the particular unregistered drug specifying its name (or chemical or grouping), and the amount of mold release. The list of diseases (conditions), as well as drugs containing narcotic drugs or psychotropic substances, is approved by the authorized federal executive body.

The document comes into force on March 1, 2020, with the exception of the provisions governing the suspension of the use of a medicinal product for medical use, the cancellation of its state registration in case of failure by the holder or owner of the registration certificate of the medicinal product to submit the required documents for determining interchangeability, which will enter into force on January the 1st  2023.

Federal Law of December 27, 2019 No. 452-ФЗ “On Amending the Federal Law“ On the Basics of Protecting the Health of Citizens in the Russian Federation ”

The law has supplemented the list of life-threatening and chronic progressing rare (orphan) diseases leading to a reduction in the life expectancy of citizens or their disabilities: unspecified aplastic anemia, hereditary deficiency of factors II (fibrinogen), VII (labile), X (Stuart-Prauer), for the treatment of which medicines will be purchased centrally, at the expense of the federal budget.

Federal law comes into force on January 1, 2020.

Federal Law of December 27, 2019 No. 481-ФЗ “On Amending Certain Legislative Acts of the Russian Federation”

Federal law expands the requirements for the production and circulation of ethyl alcohol and alcohol-containing medicines. It is established that the production of the pharmaceutical substance of ethyl alcohol (ethanol) is only allowed to organizations that have a license for the production of ethyl alcohol for the production of the pharmaceutical substance of ethyl alcohol (ethanol) and a license to manufacture medicines.

There are new requirements for the production of the pharmaceutical substance of ethyl alcohol (ethanol), including those related to the method (method) and the conditions for its production, including requirements for the use of ethyl alcohol, produced on the basis of the above licenses, exclusively for the production of the pharmaceutical substance of ethyl alcohol (ethanol) and on the transfer of produced ethyl alcohol only through communications connecting the main technological equipment for the production of ethyl alcohol with containers for its acceptance, which are equipped with automatic means of measuring and accounting for the concentration and volume of anhydrous alcohol in ethyl alcohol, the volume of ethyl alcohol.

Persons engaged in the production of the pharmaceutical substance of ethyl alcohol (ethanol) are prohibited from purchasing ethyl alcohol from other persons, as well as from the supply and transportation of ethyl alcohol produced on their main technological equipment for the production of ethyl alcohol, which is subject to state registration. There is a ban on the use of the specified technological equipment for the production of pharmaceutical substances of ethyl alcohol (ethanol), alcohol-containing medicines and alcohol-containing medical devices.

Wholesale drug companies are not entitled to sell (transfer) the pharmaceutical substance of ethyl alcohol (ethanol). The transportation of the pharmaceutical substance of ethyl alcohol (ethanol) is entitled to be carried out only by its manufacturers, provided that the corresponding vehicles are equipped with special technical means of registration in automatic driving mode, which ensure the transfer of data on the movement of such vehicles across the territory of the Russian Federation.

Federal Law of December 27, 2019 No. 518-ФЗ “On Amending the Federal Law“ On Defense ”and Article 38 of the Federal Law“ On the Basics of Protecting the Health of Citizens in the Russian Federation ”

The federal law provides that the activities of certain medical (military medical) units of the Armed Forces of the Russian Federation, other troops, military units and bodies (medical posts, ship medical services, medical platoons, medical companies, medical units, medical special units, hospital ships , mobile medical teams) will be carried out without licensing.

Cases and procedures for the provision of medical care in specific conditions, namely, outside the places of permanent deployment of medical (medical) organizations, units and divisions, or the deployment of these organizations, units and divisions outside the territory of the Russian Federation, as well as the procedure for the use of those not registered in the Russian Federation of drugs and medical devices, the Ministry of Defense of Russia will be established.

It is also expected to introduce a special regime for the circulation of medicines, circulation and state registration of medical devices that were developed on the instructions of the aforementioned federal bodies, intended for use in wartime conditions, conducting military (combat) operations, performing combat (combat training), and military combat (operational and service) tasks in the field of defense and are used for the diagnosis, prevention and treatment of diseases and lesions resulting from exposure to weapons, weapons and howl technology, adverse chemical, biological and radiation factors. The specified regime is established by the Government of the Russian Federation.

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