Licensing of import of drugs has been introduced
Karina Babanly, Associate, Legal Alliance Company
On July 04, 2012 the Verkhovna Rada of Ukraine adopted the Law “On amending certain laws of Ukraine (as regards licensing of import of drugs and definition of the term “active pharmaceutical ingredient”) which made amendments to the Law of Ukraine “On licensing of certain kinds of economic activity” and supplemented it with the provision that the activity on import of drugs in Ukraine is also subject to licensing as well as other kinds of activity. It was determined by the Parliament that the drugs may be imported to the territory of Ukraine in accordance with the legislation and on the following conditions: drugs registered in Ukraine and with certificate of quality of the line of medical substance, provided by the manufacturer and drugs import license issued to importer (manufacturer or person representing drugs manufacturer in the territory of Ukraine)in the legally established order.
The list of drugs allowed to be imported by licensee and special conditions of the activity are specified in the annex to the license. Drugs import license may be issued provided the presence of the respective material and technical base, qualified personnel, and conditions of the control of quality of drugs to be imported into the territory of Ukraine.
Provided that manufacturer has determined the expiration date less than 1 year or not less than 6 months and more than 1 year, the expiration date of drugs imported into the territory of Ukraine must be not less than half of the term determined by manufacturer.
The order of import of drugs to the territory of Ukraine is determined by the Cabinet of Ministers of Ukraine.
In order to ensure compliance with the European legislation, importer of drugs to the territory of Ukraine is expected to have its authorised representative or another legal entity that would bear full scope of criminal and administrative responsibility in accordance with the national legislation for the quality, safety and effectiveness of the drugs imported. Herewith, the importer must provide:
It should be noted that since the Law has not been signed yet by the President and has not been promulgated, it is not currently effective.
This law will be effective after signature by the President (we have no doubts about it) and the next day after its signature it will be promulgated in one of the following publications: The Official Bulletin of Ukraine, Uriadoviy Kurier, newspaper “Golos Ukrainy”, “Vedomosti Vekhovnoi Rady Ukainy”, bulletin “Ofitsialniy vestnik Presidenta Ukrainy”.
Critical remarks regarding practicability of introducing licensed importing in Ukraine had been made in the process of public discussion by pharmaceutical manufacturers, their associations, lawyers and certain specialists of drugs licensing and registration bodies of the draft law before its adoption by the Verkhovna Rada of Ukraine. Besides, the provisions on import licensing do not comply with certain norms of current laws of Ukraine, international law and practice in trafficking drugs worldwide. However, no remarks, wishes, proposals and comments had been taken into consideration by legislators, because they were striving to introduce drugs import licensing at any cost.
But what must be, must be. The Law has been adopted and will be effective in no time, and the medicinal products importers will be authorized to import medicinal products into Ukraine, subject to availability of license. However, it should be noted that this rule will be effective from March 1, 2013 (from this date the provisions of the law on the introduction of import licensing shall come into force).
The law is not retroactive by the general rule. This means that business entities that import medicines to Ukraine up to March 1, 2013, are not required to retrospectively obtain the license. However, they must receive such license for further drugs importing.
Now it is difficult and impractical to carry out any analysis of the order and conditions of licensing drugs import since new licensing conditions to be introduced with regard to import of drugs are still being developed and has not yet been adopted or officially published. These conditions of licensing will presumably determine the general procedure for obtaining license and applying for license, list of documents to be submitted, and, which is the most important - the requirements to licensee, etc.
On July 04, 2012 the Verkhovna Rada of Ukraine adopted the Law “On amending certain laws of Ukraine (as regards licensing of import of drugs and definition of the term “active pharmaceutical ingredient”) which made amendments to the Law of Ukraine “On licensing of certain kinds of economic activity” and supplemented it with the provision that the activity on import of drugs in Ukraine is also subject to licensing as well as other kinds of activity. It was determined by the Parliament that the drugs may be imported to the territory of Ukraine in accordance with the legislation and on the following conditions: drugs registered in Ukraine and with certificate of quality of the line of medical substance, provided by the manufacturer and drugs import license issued to importer (manufacturer or person representing drugs manufacturer in the territory of Ukraine)in the legally established order.
The list of drugs allowed to be imported by licensee and special conditions of the activity are specified in the annex to the license. Drugs import license may be issued provided the presence of the respective material and technical base, qualified personnel, and conditions of the control of quality of drugs to be imported into the territory of Ukraine.
Provided that manufacturer has determined the expiration date less than 1 year or not less than 6 months and more than 1 year, the expiration date of drugs imported into the territory of Ukraine must be not less than half of the term determined by manufacturer.
The order of import of drugs to the territory of Ukraine is determined by the Cabinet of Ministers of Ukraine.
In order to ensure compliance with the European legislation, importer of drugs to the territory of Ukraine is expected to have its authorised representative or another legal entity that would bear full scope of criminal and administrative responsibility in accordance with the national legislation for the quality, safety and effectiveness of the drugs imported. Herewith, the importer must provide:
- Good quality system complying with the requirements of good manufacturing practices (GMP);
- Presence of qualified personnel, primarily of the Authorised person;
- Respective agreement between the Authorised persons of drugs importer and the manufacturer;
- Carrying out audit of manufacturer as regards the compliance with the requirements of good manufacturing practices (GMP);
- Transparent certification system of each imported line by the Authorised person;
- Meeting other requirements regarding import of drugs.
It should be noted that since the Law has not been signed yet by the President and has not been promulgated, it is not currently effective.
This law will be effective after signature by the President (we have no doubts about it) and the next day after its signature it will be promulgated in one of the following publications: The Official Bulletin of Ukraine, Uriadoviy Kurier, newspaper “Golos Ukrainy”, “Vedomosti Vekhovnoi Rady Ukainy”, bulletin “Ofitsialniy vestnik Presidenta Ukrainy”.
Critical remarks regarding practicability of introducing licensed importing in Ukraine had been made in the process of public discussion by pharmaceutical manufacturers, their associations, lawyers and certain specialists of drugs licensing and registration bodies of the draft law before its adoption by the Verkhovna Rada of Ukraine. Besides, the provisions on import licensing do not comply with certain norms of current laws of Ukraine, international law and practice in trafficking drugs worldwide. However, no remarks, wishes, proposals and comments had been taken into consideration by legislators, because they were striving to introduce drugs import licensing at any cost.
But what must be, must be. The Law has been adopted and will be effective in no time, and the medicinal products importers will be authorized to import medicinal products into Ukraine, subject to availability of license. However, it should be noted that this rule will be effective from March 1, 2013 (from this date the provisions of the law on the introduction of import licensing shall come into force).
The law is not retroactive by the general rule. This means that business entities that import medicines to Ukraine up to March 1, 2013, are not required to retrospectively obtain the license. However, they must receive such license for further drugs importing.
Now it is difficult and impractical to carry out any analysis of the order and conditions of licensing drugs import since new licensing conditions to be introduced with regard to import of drugs are still being developed and has not yet been adopted or officially published. These conditions of licensing will presumably determine the general procedure for obtaining license and applying for license, list of documents to be submitted, and, which is the most important - the requirements to licensee, etc.
