International cooperation

June 3, 2019

State Service of Ukraine on Medicines and Drugs Control is participating in the following international organizations:

  • Pharmaceutical Inspection Co-operation Scheme (PIC/S);
  • European Pharmacopoeia Commission;
  • UN Commission on Narcotic Drugs;
  • International Narcotics Control Board;

 

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The SMDC’s participation in the PIC/S organization helps to establish uniform requirements for medicinal products manufacturing, quality control of medicinal products, inspection of conditions of production and quality control of medicinal products in accordance with the requirements of good pharmaceutical practices and requirements of the European Union.

The SMDC ensures the fulfillment of obligations resulting from its membership in PIC/S, such as: regularly perform inspectors training, cooperating with PIC/S working groups, maintain the Quality Management System and introduce changes to the legislation of Ukraine as a consequence of EU legislation changes.

 

European Pharmacopoeia Commission

The Convention on the elaboration of a European Pharmacopoeia, with the amendments in accordance with the provisions of a Protocol, was developed by the Council of Europe in order to approve the common pharmacopoeia standards for the quality of medicinal products, harmonization of specifications of medicinal substances. The Convention, common to all Member States, is aims to gradually develop the Pharmacopoeia in Europe and defines a single set of characteristics and test methods – the official standards, applicable within the territories of these countries for active substances and excipients used in the manufacture of medicinal products.

 

UN Commission on Narcotic Drugs

The UN Commission on Narcotic Drugs is a principle body of UN in supporting countries to prevent and respond to the challenges posed by drugs, crime, corruption and terrorism. The State control over trafficking narcotic drugs, psychotropic substances and precursors based on the requirements of the Single Convention on Narcotic Drugs 1961, Convention on Psychotropic Substances, 1971, the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 and the legislative acts of Ukraine in particular the laws of Ukraine “On narcotic drugs, psychotropic substances and precursors” and “On measures against illicit traffic of narcotic drugs, psychotropic substances and precursors and abuse them”

In accordance with the requirements of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988, the State Party, if necessary, reconsiders and decides on the expediency of strengthening control over controlled substances by including in the List of Narcotic Drugs, Psychotropic Substances and Precursors their new species or by removal from the  List of substances  concerning of which there is no record of abuse or using for the production of narcotic drugs and psychotropic substances. One of the most effective organizational measures against the illegal circulation of narcotic drugs, psychotropic substances and precursors is the establishment of international control over the movement of controlled substances and products containing such substances, as well as the prohibition of the circulation substances where  negative consequences of non-medical use exceed the allowable rates.

 

International Narcotics Control Board

The main functions of INBC is to ensure that adequate supplies of drugs are available for medical and scientific uses and that the diversion of drugs from licit sources to illicit channels does not occur, monitoring Member States’ compliance with the obligations under international drugs control treaties.

The State Service of Ukraine on Medicines and Drugs Control has regularly shared information with the INBC as follows:

  • statistical information on imports and exports of narcotic drugs (quarterly in form A);
  • data on annual requirements in narcotic substances, the volume of production of synthetic drugs, the volume of opium production and the cultivation of opium poppy for purposes other than the production of opium (annually in form B);
  • data on production, manufacturing, consumption; seized narcotic substances and quantity in stock (annually in form C)
  • statistical information on imports and exports of psychotropic substances included in List II of the UN Convention against illicit Traffic in Narcotic Drugs and Psychotropic Substances (quarterly in form A/P);
  • report about the substances listed in the Convention on Psychotropic Substances of 1971;
  • annual requirements in substances for medical and scientific needs to INBC (in form B/P);
  • substances that frequently used for illicit manufacturing of narcotic drugs, psychotropic substances and precursors 

As part of a collaborative approach among international organizations, the State Service of Ukraine on Medicines and Drugs Control are constantly taking steps aimed at the implementation of European regulations and standards in the areas of quality control and safety of medicinal products, medical products, trafficking of narcotic drugs, psychotropic substances and precursors. All of the above impacts the level of trust and confidence in the industry, and thus the development of mutually beneficial cooperation.