of July 4, 2024 No. 591
About approval of the Regulations on procedure for establishment of quota of the not denatured ethyl alcohol intended for pharmaceutical production and application in medicine
Based on the Art. 96, litas. b), the second paragraph and the Art. 124, part (15) the Tax code No. 1163/1997 (special release of February 8, 2007 is repeatedly published in the Official monitor of the Republic of Moldova), with subsequent changes, the Items 4,8,16 of the Order of the State Tax Administration No. 233/2021 on updating of the Generalized base of the tax and budget practice, and also Regulations on the organization and functioning of the Ministry of Health approved by the Order of the Government No. 148/2021, of PRIKAZYVAYU:
1. Approve Regulations on procedure for establishment of quota of the not denatured ethyl alcohol intended for pharmaceutical production and application in medicine.
2. To submit the list of users and quotas of the not denatured ethyl alcohol intended for pharmaceutical production and application in medicine allocated to them to the Government for approval.
3. Confer responsibility for development and promotion of the draft decision of the Government about procedure for establishment of quota of the not denatured ethyl alcohol intended for pharmaceutical production and application in medicine on Management the politician in the field of drugs and medical products.
4. This order becomes effective from the date of publication in the Official monitor of the Republic of Moldova.
5. To impose control of observance of execution of this order on the state secretary Alexander Gasnash.
Minister
Nemerenko is scarlet
Appendix No. 1
to the Order of the Ministry of Health the Republic of Moldova of July 4, 2024 No. 591
1. The regulations on procedure for establishment of quota of the not denatured ethyl alcohol intended for pharmaceutical production and application in medicine (further - the Provision), establish procedure for giving and consideration of the applications of economic agents about procedure for establishment of quota of not denatured ethyl alcohol according to tariff line items 220710000 and 220890910, intended for pharmaceutical production and application in medicine.
2. The list of economic agents and quotas of the not denatured ethyl alcohol intended for pharmaceutical production and medical application allocated to them are established and affirm the Government annually.
3. The terms used in this Provision are provided in the Tax code No. 1163/1997, the Customs code No. 95/2021, the Law No. 1100/2000 on production and turnover of ethyl alcohol and alcoholic products, the Law No. 1409/1997 on drugs, the Law No. 10/2009 on the state supervision of public health care, the Law No. 160/2011 on regulation entrepreneurial activities by permission.
4. The statement on establishment of quota of the not denatured ethyl alcohol intended for pharmaceutical production and application in medicine the next calendar year is constituted according to sample from appendix No. 1 to the Provision and moves in the Ministry of Health till October 30 of the current calendar year.
5. The following documents are enclosed to the application:
1) the statement from the state register of legal entities;
2) copy of the license for pharmaceutical activities;
3) the copy of the document confirming the property right or uses of ethyl alcohol of standard storage location;
4) confirmation of recognition by the winner of the procedure of public procurement of amounts of ethyl alcohol for use in medicine;
5) reasons for quota of the not denatured ethyl alcohol which is subject to purchase within the mode of release from the excise duty for the corresponding calendar year based on the forecast of assortment and quantity of the pharmaceutical products planned to production and realization for the sample specified in appendix No. 2 to the Provision;
6) the report on use of amount of not denatured ethyl alcohol in production process of the pharmaceutical products falling under the mode of release from the excise tax on the sample given in appendix No. 3 to the Provision if the applicant used this privilege based on earlier published regulation.
6. The statement and documents attached to it are filed on paper or electronically, the confirmed digital signature.
7. The politician in the field of drugs and medical products will provide management:
1) consideration of the applications about establishment of quota of the not denatured ethyl alcohol exempted from the excise tax;
2) pronouncement of decisions according to statements;
3) establishment of quota of not denatured ethyl alcohol, concerning the allowed statements;
4) development, coordination and promotion of the draft decision of the Government about procedure for establishment of quota of the not denatured ethyl alcohol intended for pharmaceutical production and use in medicine.
8. Person responsible for project development considers the documents submitted by applicants on compensation and, depending on circumstances, notifies the applicant on provision of the additional information concerning the considered subject, showing responsibility in implementation of the obligations. with observance of provisions of the legislation on the personal data protection and information which is trade secret.
9. In case of conflict of interest or availability of personal interest person responsible for project development shall notify on it the head of department in writing and refrain from any activities which can generate conflict of interest or cause suspicions of bias according to the Law No. 82/2017 on integrity, the Law No. 133/2016 on declaring of property and private interests.
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