Legislative regulation regarding the import of medicines
As a general rule, it is allowed to import medicines into the Eurasian Economic Zone that are included in the Unified Register of Registered Medicines of the EAEU or in the corresponding register of the state member. But when importing, it is necessary to follow the special requirements that are introduced by each country which is a member of the EAEU. It should also be considered that activities related to the circulation of medicines belong to licensed activities, and the choice of distributors and customers is regulated by strict rules.
The procedure of importing medicines on the example of Russia
Issuance of licenses in the Russian Federation is associated with a number of restrictions when choosing distributors and customers. Thus, only a legal entity with a special license can act as an importer in Russia for a commercial batch of medicines. Besides, transportation and storage of medicines should be carried out by organizations that have the necessary permits and qualified personnel. When importing medicines into Russia, it is necessary to comply with the requirements stipulated by Decree of the Government of the Russian Federation No. 771 of September 29, 2010. In accordance with them, the following legal entities can import medicines into Russia:
- manufacturers of medicines for their own production purposes,
- wholesale organizations, foreign developers and manufacturers of medicines or other legal entities authorized by the developers – for conducting clinical trials, registration and quality control,
- scientific and educational organizations of higher education and manufacturers of medicines – for the development, research, safety control, quality and effectiveness of medicines,
- medical and other organizations listed above to provide medical care according to the vital indications of a particular patient.
In some cases, import of a certain batch of medicines requires a permit from the Ministry of Healthcare, which is executed in electronic form and signed with a digital signature. An application for such permission and the results of the decision are recorded in a special register of the Ministry of Healthcare. In practice, the deadline for obtaining such permission, as a rule, does not exceed five working days. The following information must be specified in the application for permission:
- name of the medicine,
- dosage formulation,
- dose, concentration, packaging,
- name of the organization – manufacturer of the medicine,
- country of the medicine manufacture.
Besides, depending on the purpose of the medicine import, a number of documents must be provided. These include, in particular:
- copies of the applicant’s constituent and registration documents,
- certificate of quality of the imported medicines,
- permission of the Ministry of Healthcare to conduct a clinical trial,
- conclusion of a consultation of doctors about the need to use an unregistered medicine for health reasons,
- copies of documents confirming proper marking for the use of medicines in clinical trials.
Moreover, in a number of cases, import of medicines is possible without obtaining permission from the Ministry of Healthcare of the Russian Federation, namely for the following purposes:
- personal use of medicines by individuals,
- use of medicines by employees of the diplomatic corps or representatives of international organizations accredited in the Russian Federation,
- treatment of transit passengers and crew members,
- treatment of participants in international cultural and sporting events and participants in international expeditions.
In addition, Russian legislation contains special rules governing the order in which medicines for medical use are put into circulation. The mandatory certification and declaration of conformity in relation to medicines has been replaced by the rules on obtaining a test report for the first three series or batches of medicines imported into Russia for the first time. This report confirms the compliance of imported medicines with regulatory requirements. For putting into circulation each batch or series of immunobiological medicines, a special permission of Roszdravnadzor is required.
All essential information about medicines put into circulation should be entered into a special automated information system. Although these responsibilities are assigned to Russian importers, and not to foreign manufacturers, the latter are still interested in providing their partners with the necessary samples and documents in time, so that the medicines they produce can be freely put into circulation on the territory of Russia.
The next major change will take place 01.07.2020.
In the middle of the year, the next tightening requirement will come into force. From 01.07.2020, all medicines intended for the Russian market must be marked with a digital code. Such a unique DataMatrix code for each product will provide protection against counterfeiting and will allow tracking the movement of medicines from the manufacturer to the final consumer. For this purpose, information on all stages of the medicine movement is entered into the digital marking system “Chestniy Znak”. At the same time, the need for such marking is quite burdensome and poses serious technical difficulties for both Russian and foreign manufacturers. However, over time, similar marking requirements for medicines will be expected to apply throughout the EAEU.