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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of March 31, 2004 No. 411

About approval of the Regulations on the State register of medicines

(as amended on 15-04-2020)

The Cabinet of Ministers of Ukraine decides:

Approve Regulations on the State register of medicines of Ukraine it (is applied).

Prime Minister of Ukraine

V. Yanukovych

 

Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 31, 2004 No. 411

Regulations on the State register of medicines

1. The state register of medicines (further - the Register) contains data on the medicines permitted for production and application in Ukraine.

2. The register is kept for the purpose of providing:

identifications of subjects of business activity which enable production and the realization of medicines on professional basis with observance of the corresponding standards and rules in this sphere;

the organizations of statistical observations in the sphere of circulation of medicines;

interactions on unified methodical bases with databases of other central executive bodies;

publicity and openness of information on subjects of business activity;

identifications of the medicines which are purchased according to Item 19 parts five of article 3 of the Law of Ukraine "About public purchases".

identifications of medicines which are bought by person authorized on implementation of purchases in health sector for accomplishment of programs and implementation of centralized actions for health care.

3. Keeps the Register of MZ.

4. The following data on medicine are entered in the Register:

name of medicine (trade name, international unlicensed name);

name of the manufacturer, its location and location of its production capacities;

synonyms, chemical name, complete composition of medicine;

pharmacological effect, pharmakoterapevtichesky group of medicine;

indications, contraindications, precautionary measures, interaction with other medicines;

methods of application, dose of active ingredient in each unit and quantity of units in packaging;

side effect, form of release, the storage condition, expiration date, conditions of leave and belonging of medicine to medicines which advertizing is forbidden;

the instruction for medical application of medicine;

information on belonging to medicines which are bought according to Item 19 parts five of article 3 of the Law of Ukraine "About public purchases";

information on medicine belonging to medicines which can be in circulation in the territory of Ukraine only for the purpose of non-paid supply to structural divisions concerning health care of the regional, Kiev and Sevastopol city state administrations or to subjects of managing which have the license for implementation of economic activity on medical practice, by results of the purchases for means of the government budget conducted by person authorized on implementation of procurements in health sector for accomplishment of programs and implementation of centralized actions for health protection if such medicine underwent state registration as medicine which is the registered competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada it is also applied in the territory of such countries or competent authority of the European Union according to the centralized procedure and applied in the territory of member states of the European Union or as medicine, irrespective of the country of the producer with marking, the instruction for application and the short characteristic of medicine stated in original language (in the language other than state);

data on registration of medicine in the United States of America, the Swiss Confederation, Japan, Australia, Canada, and also member states of the European Union if such medicine underwent state registration as medicine which is registered by competent authority of the United States of America, of the Swiss Confederation, Japan, Australia, Canada, the medicine according to the centralized procedure registered by competent authority of the European Union and is applied in the territory of said countries or member states of the European Union, including country name of registration, body of registration and registration date;

this to rather advance registration, re-registration or cancellation of registration of medicine.

Data on medicine are entered in the Register in connection with:

GSTU ISO 21090:2017 "Informatics in health care. The harmonized types of data for exchange of information";

GSTU ISO 11615:2018 "Informatics in the field of health care. Identification of medicines. Elements and structures of data for unique identification and exchange of the regulated information on medicines";

GSTU ISO 11616:2018 "Informatics in the field of health care. Identification of medicines. Elements and structures of data for unique identification and exchange of the regulated information on pharmaceutical medicines";

GSTU ISO 11238:2018 "Informatics in the field of health care. Identification of medicines. Elements and structures of data for unique identification and exchange of the regulated information on substances";

GSTU ISO 11239:2018 "Informatics in the field of health care. Identification of medicines. Elements and structures of data for unique identification and exchange of the regulated information on pharmaceutical forms of dosage, representation units, ways of introduction and packaging";

GSTU ISO 11240:2017 "Informatics in health care. Identification of medicines. Elements and structures of data for unique identification and exchange of units of measure";

GSTU ISO/TS 20443:2018 "Informatics in the field of health care. Identification of medicines. Management on implementation of ISO 11615 concerning elements and structure of data for unique identification and exchange of the regulated information on medicines";

GSTU ISO/TS 20451:2018 "Informatics in the field of health care. Identification of medicines. Management on implementation of ISO 11616 concerning elements and structure of data for unique identification and exchange of the regulated information on pharmaceutical medicines";

GSTU ISO/TS 20440:2018 "Informatics in health care. Identification of medical means. Management on implementation of elements and structures of data according to ISO 11239 for unique identification and exchange of the regulated information on pharmaceutical forms of dosage, representation units, ways of introduction and packaging";

GSTU ISO/TS 19256:2018 "Informatics in the field of health care. Requirements to systems of dictionaries of medicines for health care";

GSTU ISO/IEC 17523:2018 "Informatics in health care. Requirements to electronic recipes";

GSTU ISO/TS 19844:2018 "Informatics in the field of health care. Identification of medicines. Management on implementation of EN ISO 11238 concerning elements and structure of data for unique identification and exchange of the regulated information on substances";

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