The Faculty of Medical Law will talk about the administrative regulations of Roszdravnadzor to provide a state service for issuing a certificate for the right of import (export) of the NA and PV and their precursors if they are medicines.

Certificate for the right of import (export) of the NA, PV and their precursors that are drugs

July 07, 2015, the Ministry of Health of Russia on the basis of Order No. 421n approved the administrative regulations of the Russian Roszdravnadzor for the provision of a state service for issuing a certificate for the right to import (export) of narcotic drugs, psychotropic substances and their precursors (hereinafter – NA and PV), if they are drugs (registered in the Ministry of Justice of Russia 03.08.2015 No. 38317) (hereinafter referred to as administrative regulations No. 421n).

In order to tell about the new document, the Faculty of Medical Law decided to remind a little about the system of importation (exportation) of narcotic drugs, psychotropic substances and their precursors, which is established in the Russian Federation in accordance with the requirements of regulatory legal acts, namely, by Federal Law of 08.01. 1998 No. 3-FZ "On narcotic drugs and psychotropic substances" (hereinafter – №3-ФЗ), Decree of the Government of the Russian Federation of 21.03.2011 No. 181 "On the procedure for entering into the Russian Federation and export from the Russian Federation of narcotic drugs, psychotropic substances and their precursors" (hereinafter referred to as Order No. 181).

Persons engaged (export) of narcotic drugs and psychotropic substances

To begin, it should be noted that the list of narcotic drugs, psychotropic substances and their precursors to be controlled in the Russian Federation approved by the Decree of the Government of the Russian Federation of 06/30/1998 No. 681 (hereinafter referred to as the List No. 681).

In this area, depending on the category of NA and the PV, the legislator allocates two persons who are entitled to import (export) of a certain category of NA and PV (part 1 of Article 28 No. 3-ФЗ):

1. State unitary enterprises – when importing (exporting) of the NA and PV, listed in the lists I and II of the list No. 681, as well as import (export) of precursors listed in List I and Table I of the list IV list No. 681;
2. Legal entities Regardless of their forms of ownership – when importing (exporting) of the NA and PV, listed in the list III of the list No. 681, as well as import (export) of precursors entered in Table III of the list IV List No. 681.

Individual entrepreneurs are not included in this group, because it is not entitled to carry out activities on the import (exportation) of the National Assembly and PV on the basis of the requirements of Article 28 No. 3-FZ.

Conditions for the implementation of importation (exportation) of narcotic drugs and psychotropic substances

The condition for the implementation of the above-mentioned entities of the import (export) of the National Assembly of the National Assembly of the National Assembly of the National Assembly of the National Assembly of National Assembly, included in the list of No. 681, is the availability of a license for the right of import (exportation) of the National Assembly of the National Assembly of the National Assembly of the National Assembly № 3-ФЗ).In the Russian Federation, this is the Ministry of Industry and Trade of the Russian Federation.

It should be noted that in accordance with part 3 of Article 28 No. 3-FZ, it is allowed to import (export) of individual precursors entered in Table III of the list of IV list No. 681, without registration of a license in size and deadlines, which are established by the Government of the Russian Federation. Such a list should be established by the Government of the Russian Federation, however, to date, the regulatory legal act is not adopted.

On the order of importation in the Russian Federation and export from the Russian Federation of narcotic drugs, psychotropic substances and their precursors

Order No. 181 there are two types of import (export) of the NA and PV:

• in the implementation of foreign trade activities with the States Parties to the Customs Union within the EurAsEC (Eurasian Economic Community) (hereinafter – the order for the EurAsEC participants);
• In the implementation of foreign trade activities with non-participants in the Customs Union within the framework of the EurAsEC (hereinafter – the order for non-participants in the EurAsEC).

Obtaining a license for the right of import (exportation) of narcotic drugs, psychotropic substances and their precursors

To obtain a license for the right of import (export) of the NA and PV included in the list No. 681, legal entities must obtain (part 3 of Article 28 No. 3-ФЗ):

• If ns and PV are drugs – a certificate for the right of import (export) of the National Assembly and PV, issued by Roszdravnadzor);
• Permission to the right of import (export) of NA and PV, issued by the Ministry of Internal Affairs of Russia.

Order No. 181 for states that are not parties to the Customs Union within the framework of the EurAsEC provided and import (export) of NA and PV included in Section 2.12 of the Unified List of Goods to which prohibitions or restrictions on the import or export of the Customs Union by States in the framework of the EurAsEC In trade with third countries approved by the decision of the EurAsEC Interstate Council of November 27, 2009 No. 19 (hereinafter – the Unified List).

To carry out the importation (exportation) of the NA and PV, made only in a single list, the one-time license of the Ministry of Industry and Trade of the Russian Federation should be obtained in accordance with the procedure established by Article 3 of the Agreement on Licensing Rules in the field of foreign trade in goods from 06/09/2009 without obtaining permission and certificate (paragraph 4, 6 of the order for non-EurAsEC).

To obtain a single license for importing (exporting) of the NA and PV, submitted simultaneously to the list No. 681 and a single list, it is necessary to obtain permission from the Ministry of Internal Affairs of Russia for the right of import (export) of the NA and PV, and the Roszdravnadzor certificate (if NA and PV are drugs). Additionally, we note that permission from the Ministry of Internal Affairs of Russia from 09/08/2017 can be obtained on the basis of the administrative regulations of the Ministry of Internal Affairs of the Russian Federation on the provision of public services for issuing permits of the Ministry of Internal Affairs of the Russian Federation for the right to import (export) of narcotic drugs, psychotropic substances and their precursors , approved by the Order of the Ministry of Internal Affairs of Russia of 02.08.2017 No. 593.

Administrative regulations for the provision of public services for the issuance of a certificate for the right to import (export) NA and PV, if they are medicines

We return to Administrative Regulation No. 421n, which establishes the requirements for the subject of regulation (the state service for issuing a certificate for the right to import (export) NA and PF), the range of applicants, the requirements for the procedure for informing about the provision of public services, the standard for the provision of public services, which includes in himself and the terms for the provision of public services, an exhaustive list of documents required for the provision of public services, an exhaustive list of grounds for refusing to provide public services, a pre-trial (out-of-court) procedure for appealing against decisions and actions (inaction) of Roszdravnadzor and its officials.

Particular attention should be paid to paragraph 16 of Administrative Regulation No. 421n, which establishes the terms for the provision of public services – for the issuance (refusal to issue) a certificate – 15 days from the date of receipt of the application and copies of documents by Roszdravnadzor, while paragraph 12 of the Procedure for EurAsEC participants provides making a decision to issue or refuse to issue a certificate – within 30 days from the date of submission of the application and copies of documents.

Form of a certificate for the right to import (export) NA and PV, if they are medicines

The form of the certificate for the right to import (export) NA and PV was approved by the Order of Roszdravnadzor dated August 19, 2013 No. 4221-Pr / 13.

An exhaustive list of documents required to obtain a certificate for the right to import (export) NA and PV

The list of documents required to obtain a certificate for the right to import (export) NA and PV (if they are medicinal products) is exhaustive and includes:

• permission from the competent authority of the importing state to import into its territory a specific consignment of narcotic drugs, psychotropic substances or precursors, if this is provided for by the legislation of the relevant state, or an official notification from this authority that the specified permission is not required;
• a foreign trade contract (agreement) in respect of narcotic drugs, psychotropic substances or precursors with documentation (additional agreements, amendments, additions, amendments) and appendices that are an integral part of the contract (agreement);
• commission agreement (if the applicant is a legal entity – commission agent);
• a document confirming the authority of the head or other person who signed the application to act on behalf of the applicant – a decision on the appointment or election of the head or other person to the position and an extract from the constituent documents of the applicant, according to which the head or other person has the right to act on behalf of applicant without a power of attorney.In case, on behalf of the applicant, a personal person has a power of attorney for the right to perform actions on behalf of the applicant, signed by the head or authorized by him. If such a power of attorney is signed by a person authorized by the leader, a document confirming the powers of this person to sign it is also submitted.
• Quality Certificate or other document confirming the quality of a narcotic drug, psychotropic substance or precursor (in case of import (export) of narcotic drugs, psychotropic substances or precursors that are drugs). If the drugs planned to be imported, psychotropic substances or precursors that are drugs are not manufactured on the day, this copy is submitted to Roszdravnadzor within 10 working days from the date of importation.

Renewal, suspension and cancellation of the certificate for the right of import (export) of the NA and PV

In case of changes in the organizational and legal form, the name or address of the location of the legal entity, the certificate is reissued after making an appropriate entry into the Unified State Register of Legal Entities.

In the case of administrative suspension of the legal entity for violation of the legislation of the Russian Federation in the field of turnover of NA and the PV, the certificate is also suspended for the period of administrative suspension of activities.

If a license for the turnover of NA and PV is canceled – this entails the cancellation of the certificate from the date of entry into force of the court's decision to cancel such a license.

Responsibility for violation of the rules of import (export) of the NA and PV

Violation of the rules of the import (exportation) of ns or PV precursors, included in Table II and III of the list IV List No. 681 entails administrative responsibility in accordance with Part 2 and 3 of Article 6.16 of the Code of Administrative Offenses.

Violation of the rules of import, the export of NA and PV, which caused their loss, as well as the violation of the rules of import, the export of NA and PV, if this act is committed by the person, the responsibility of which compliance with these rules, and also, if this act is committed from mercenary motivations or entailed By negligence causing harm to human health or other serious consequences entails criminal liability in accordance with Parts 1 and 2 of Article 228.2 of the Criminal Code of the Russian Federation.