The Rada adopted amendments to the law on blood donation and the importation of medicines

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The Rada adopted amendments to the law on blood donation and the importation of medicines

The Rada adopted amendments to the law on blood donation and the importation of medicines

02/02.2020 14:42

Ukrinform

The Verkhovna Rada adopted Law No. 2429 on the amendment of certain Ukrainian laws concerning the elimination of artificial bureaucratic obstacles and corruption factors in the field of health care.

The law was supported by 332 deputies, reports the Ukrinform correspondent.

“The purpose of the bill is to remove artificial bureaucratic barriers and corruption factors in the health sector, in particular by reducing the time taken to introduce generic medicines to the Ukrainian market, by creating legal conditions for importation into the customs territory of Ukraine of unregistered medicines necessary for the medical supply of Ukrainian citizens – participants in international operations to maintain peace and security, to remove obstacles to the development of the service system of blood, to create favorable conditions for the importation of narcotic drugs, psychotropic substances and precursors by the manufacturers of national pharmaceutical products into the territory of Ukraine in the form of pharmaceutical substances for the own production of medicines, “says the explanatory note.

See also: In Ukraine, blood stocks have more than halved – Stepanov

The law provides that it will not be considered as a disclosure and an unfair commercial use of the registration information of the reference medicine by the applicant who refers to it and their use in the registration documents submitted for the registration of ” another medicine containing the same active substance as the reference medicine / brand name medicine (amendments to Article 9 of the Medicines Law).

The law proposes not to infringe the rights arising from a patent for an invention (utility model), to import products made using the invention (utility model) for research and / or the use of the invention (utility model) in studies carried out with the purpose of preparing and submitting information for the registration of a medicine (amendments to Article 31 of the Ukrainian Law on protection of invention rights and utility models).

The document authorizes, by a separate decision of the central executive authority which implements state policy in the field of health care, the importation of medicines from foreign countries not registered in Ukraine for assistance purposes medical (medical use) of military personnel and persons of ordinary and dominant composition who are sent to participate in an international peace and security support operation within the framework of the national contingent or national personnel (amendments to article 17 of the law Ukrainian drugs).

See also: the Ministry of Health registered 30 drugs per week

The law should also improve the ban on the export of donated blood and its components outside of Ukraine (with the exception of the decision of the Cabinet of Ministers of Ukraine to provide humanitarian aid, provided that the needs of public health institutions in Ukraine in donor blood and its components are fully met), to abolish the obsolete regulation of the export of blood products, and also allow the taking of plasma for fractionation, subject to its processing and from its use for the production of blood products in Ukraine, to commercial entities (amendments to the Ukrainian law on blood donation and its components).

According to the law adopted, the requirement to provide a quality certificate for a narcotic or psychotropic substance will be replaced by a requirement on the provision of information certified by the applicant on the quantitative chemical composition of the narcotic or the substance psychotropic according to the specifications or the relevant technical documentation of the manufacturer (exporter or importer) (amendments to Ukrainian law on narcotic drugs, psychotropic substances and precursors ”).

According to the materials: ukrinform.ru

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