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PRESIDENTIAL DECREE OF THE REPUBLIC OF BELARUS

of August 30, 2021 No. 327

About development of pharmaceutical industry

For the purpose of further development of pharmaceutical industry, creation of new pharmaceutical productions, I decide growths in volumes of release of medicines and growth of their export:

1. According to the procedure and on the conditions determined by Council of Ministers of the Republic of Belarus within the means provided in the republican budget on other questions in the field of the industry subsidies can be provided to the pharmaceutical organizations on:

compensation in 2022-2030 of part of interest for using the credits received under guarantees of the Government of the Republic of Belarus for implementation of investment projects on creation, technical retrofitting and reconstruction of the production capacities directed to creation of new productions and (or) extension of the nomenclature of medicines;

compensation in 2022-2025 of part of costs, connected:

with carrying out preclinical (not clinical) researches and clinical trials (testing), and also with performance of works on examination and registration (registration confirmation) of medicines, reduction of registration files in compliance with requirements of the Eurasian Economic Union;

with receipt of certificates of conformity to requirements of Rules of proper production practice of the Eurasian Economic Union;

with inspection and certification of production of medicines on compliance to the international requirements of proper production practice.

Subsidies are provided:

the parts one of this Item specified in the paragraph the second, - in the presence of the positive conclusion of the state complex examination of the investment project which is carried out in accordance with the established procedure;

the parts one of this Item specified in paragraphs by third or pole, - in case of achievement in 2022-2025 by the pharmaceutical organizations of the indicators finished by it in accordance with the established procedure for profitability of sales in the industry and to growth rates of commodity export.

2. Exempt during implementation of investment projects (appendix 1) from taxation by import customs duties (taking into account the international obligations of the Republic of Belarus) and the value added tax processing equipment, accessories and spare parts to it, the raw materials and materials (further - goods) imported on the territory of the Republic of Belarus for exclusive use in the territory of the Republic of Belarus for the purpose of implementation of these investment projects.

The bases for release of goods from taxation are determined by import customs duties and the value added tax in appendix 2.

3. Determine that when implementing public procurements the customer (organizer) has the right to carry out procurement procedure from one source for acquisition of the medicines made on complete production cycle * as a result of accomplishment in 2021 and the next years of research and experienced and technological works within state programs, the state scientific and technical programs and state programs of scientific research.

The list of medicines which acquisition based on part one of this Item is possible using procurement procedure from one source takes place and supported in urgent condition by the Ministry of Health in the state information and analytical management system public procurements.

______________________________

* For the purposes of this Decree complete production cycle is understood as the sequence of stages of receipt of medicine including acquisition and (or) production of initial raw materials (pharmaceutical substances and excipients), materials, accomplishment of stages of engineering procedure, including packaging process, quality control, issue of permission to release, storage, realization of medicines.

4. Confer the personal responsibility for achievement of the indicators provided in paragraph three of part two of Item 1 of this Decree on heads of the pharmaceutical organizations, the Minister of Health, the Chairman of Presidium of National academy of Sciences of Belarus, the Deputy prime minister of the Republic of Belarus according to distribution of obligations.

5. To Council of Ministers of the Republic of Belarus:

when forming drafts of the republican budget for 2022 and the subsequent financial years to consider provisions of this Decree;

in three-months time to take other measures for implementation of this Decree.

6. This Decree becomes effective in the following procedure:

Item 3 - since January 1, 2025 is also effective within two years;

other provisions of this Decree - after its official publication.

President of the Republic of Belarus

A. Lukashenko

Appendix 1

to the Presidential decree of the Republic of Belarus of August 30, 2021 No. 327

The list of investment projects for which implementation the goods imported by the pharmaceutical organizations are exempted from taxation by import customs duties and the value added tax

Name of the investment project *

Realization term, years

Name of the pharmaceutical organization

1. Creation of modern automated production of antineoplastic medicines in the form of liofilno the dried-up powders, concentrates and solutions for injections

2020–2025

RUP of Belmedpreparata, Minsk

2. Case construction for placement of storage facilities and production of unsterile medicines on the production site in . Lead

2021–2024

"

3. Creation of production of medicines in the form of eye drops on BFS technology

2022–2025

"

4. Reconstruction of the tablet shop of JSC BZMP to the address: Borisov, Ulitsa Chapayeva, 64

2021–2025

 JSC BZMP, Minsk region, Borisov

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