It is registered
Ministry of Justice of Ukraine
August 11, 2011
of April 26, 2011 No. 237
About approval of the Procedure for import to the territory of Ukraine of the unregistered medicines, standard samples, reagents
According to article 17 of the Law of Ukraine "About medicines", the paragraph the fourteenth subitem 8.8 of the subitem 8 of item 4 of the Regulations on the Ministry of Health of Ukraine approved by the Presidential decree of Ukraine of 13.04.2011 No. 467, taking into account requirements of Directives of the European Parliament and Council 2001/20/EU of 04.04.2001 about approach of the laws, bylaws and administrative provisions of state members concerning input of proper clinical practice when carrying out clinical testing of medicines for the use by the person, 2004/10/EU of 11.02.2004 about approach of the laws, bylaws and administrative provisions concerning use of the principles of proper laboratory practice and control of their application in testing for availability of chemicals (the codified version), 2001/83/EU of 06.11.2001 about the Code of community concerning the medicines intended for consumption by people and also the state and international standards on ought production, clinical and laboratory the practician I ORDER:
1. Approve the Procedure for import to the territory of Ukraine of the unregistered medicines, standard samples, reagents which is applied.
2. Recognize to invalid:
the order of the Ministry of Health of Ukraine of 15.05.97 No. 143 "About procedure for import to the territory of Ukraine of the unregistered medicines", registered in the Ministry of Justice of Ukraine 11.06.97 for No. 215/2019;
3. To department of regulatory policy in the field of drug circulation and products in health care system of the Ministry of Health of Ukraine to provide provision to the State Customs Service of Ukraine of electronic copies of messages concerning import to customs area of Ukraine of the unregistered medicines, standard samples, reagents with imposing of the digital signature of the head of authorized division of the Ministry of Health of Ukraine.
4. Stetsiva V. V. in accordance with the established procedure to provide to the director of the department of regulatory policy in the field of drug circulation and products in health care system submission of this order on state registration in the Ministry of Justice of Ukraine.
5. To impose control over the implementation of this order on the First Deputy Minister O. V. Anishchenko.
I. M. Emets
Approved by the Order of the Ministry of Health of Ukraine of April 26, 2011 No. 237
1.1. This Procedure is directed to settlement of the procedure:
import to the territory of Ukraine of the unregistered medicines, namely:
samples of substances (including in shape pelite, premix, granulate and so forth) for carrying out chemical, physical, biological, microbiological, pharmacological, toxicological and other scientific research, and also research of stability, development and approbation of analytical methods for carrying out preclinical studying of their specific activity and safety;
the researched medicines, reference medicines, placebo samples (comparison medicines) for clinical testing and scientific research;
samples of medicines in dosage forms for state registration;
finished pharmaceutical products for exhibiting at exhibitions, conferences and so forth without sales right;
finished pharmaceutical products for medical support (without sales right) divisions of armed forces of other states which according to the law are allowed on the territory of Ukraine;
finished pharmaceutical products for individual use by citizens;
in cases of natural disaster, catastrophic crashes, epidemic disease and so forth;
import to the territory of Ukraine of standard samples of medicines and/or substances-impurity, biological standard medicines (comparison substances), reference ranges and reagents for carrying out laboratory research of quality of medicines;
for the purpose of medical support (medical application) of the military personnel and faces of the private and the commanding structure and other persons who according to the law go by Ukraine for participation in the international peace support operation and safety as a part of the national contingent or national personnel perform tasks during conducting anti-terrorist operation, transaction of the Integrated forces, implementation of actions for ensuring national security and defense, repulse and control of the armed aggression of the Russian Federation in the Donetsk and Luhansk regions, during action of emergency state, the special period;
the unregistered medicines for treatment of the rare (orphan) diseases developed only for treatment of rare (orphan) diseases which are in accordance with the established procedure allowed to application in the territory of the United States of America or member states of the European Union;
the unregistered medicines, for the purpose of delivery by results of the purchase which is carried out by person authorized on implementation of purchases in the field of health care for accomplishment of programs and implementation of centralized actions for health care for means of the government budget, or the purchase which is carried out with involvement of person authorized on implementation of purchases in the field of health care for means of local budgets on condition of availability of set of the following circumstances:
in Ukraine there are no alternative means for prevention and/or treatment of the corresponding diseases (there are no medicines registered in Ukraine with the corresponding active ingredient);
the need for such medicines for Ukraine is limited, that is medicine is provided for use by the insignificant number of patients;
the corresponding medicines are in accordance with the established procedure allowed to application in the territory of one of the following countries: The United States of America, the Swiss Confederation, Japan, Australia, Canada or according to the centralized procedure, in member states of the European Union are also applied in one of said countries.
1.2. This Procedure extends on business entities which import the unregistered medicines, standard samples, reagents on customs area of Ukraine.
In this Procedure terms are used in such value:
the electronic message - the letter with indication of information concerning opportunity or impossibility of import to customs area of Ukraine of the unregistered medicines, for individual use by citizens with the imposed digital signature of the head of authorized division of the Ministry of Health of Ukraine or his deputies which is sent by means of electronic communication the relevant department of the Ministry of Health of Ukraine to the State Customs Service of Ukraine;
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