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Development Supporting Program of the Pharmaceutical Productive Chain - PROFARMA

» PROFARMA - Public Producers

PROFARMA - Public Producers subprogram is divided into two phases, as follows: 

the first phase consists of contracting a study with the purpose of preparing a strategic plan for insertion of public producers into the National Health System, to promote an increase in the efficacy and efficiency of the public system of purchases and distribution of products related to health, as well as of public producers individually and jointly; and 

the second phase consists of implementing the results from the first phase, offering non-reimbursable financial support to public producers, for their insertion into the National Health System. 


» Second Phase: PROFARMA - Public Producers

» Purposes

Support the implementation of a strategic planning, aiming at inserting the public producers into the National Health System; 

Support the Public Producers' investments for the construction, expansion and modernization of the productive capacity of reagents and devices for diagnosis, hemoderivatives, immunobiologicals, chemical intermediates and vegetal extracts for therapeutic purposes, active principles and drugs for human use of strategic interest to the National Health Policy; 

Support initiatives directed to the modernization or implementation of improvements in the organizational, administrative, management, trading, distribution and logistic structure of Public Producers; 

Support Public Producers' investments for adjustment to requirements of the national regulatory agency - Agência Nacional de Vigilância Sanitária [ANVISA], as well as for adjustment to requirements of international regulatory agencies and WHO - World Health Organization; 

Support, on a distinguished way, innovative projects of Public Producers, with or without cooperation of Technological Scientific Institutions, related to radical or incremental innovations; and 

Support projects that aim at contributing to the construction and consolidation of health innovation infrastructure in the Country. 



» Clients

Direct or indirect public administration.  



» Modality of the operation

Non-reimbursable application: funds from the Social Fund and the Technological Fund [FUNTEC] may be applied, taking into account the specific rules in force for such funs.



» General conditions

» BNDES Share

Up to 80%, being the Ministry of Health, State or Municipal Secretariats necessarily responsible for the remaining funds, correspondent to 20% counterpart. 

The counterpart, corresponding to at least 20% of total investment, is expected to be made in the beginning of the execution of the project, and BNDES will be responsible for disbursing the final portion, corresponding to up to 80% of total investment.



» Standards for Support

For projects related to the acquisition of Good Practices in Manufacturing and Good Practices in Laboratory: 

-  Will be received for analysis those projects presented by any Brazilian Public Producer that, within the last five years, has supplied its products to the Single Health System [SUS]. 
-  The projects presented for analysis will necessarily be participants to the investment plan generated at Phase 1 of PROFARMA- Public Producers. 
-  The contrapart funds from the Ministry of Health State or Municipal Secretariats should be necessarily approved at the public budget. 

For projects related to Research, Development and Innovation (R,D&I) of reagents and devices for diagnoses, hemoderivatives, immunobiologicals, chemical intermediates and vegetal extracts for therapeutic purposes, active principles and drugs for human use of strategic interest to the National Health Policy: 

- Will be received for analysis those projects presented by any Brazilian Public Producer that, within the last five years, has performed R&D actions, internally or by means of an agreement or convention with foreign institutions of research, or has also during such period absorbed new technologies, even if developed externally through agreements or conventions. 
- Research and development projects may be executed by the Producer requiring financing or also by a Scientific-Technologic Institute, or a Supporting Institution. 
- Projects presented for analysis will necessarily be participants of the investment plan generated at the First Phase of PROFARMA- Public Producers. 
- The contrapart funds from the Ministry of Health State or Municipal Secretariats should be necessarily approved at their respective budgets. 
- Projects presented for analysis will necessarily be participants to the investment plan generated at First Phase of PROFARMA- Public Producers. 




» Operating Procedures

The Public Producers will be responsible for addressing the projects, in accordance with the established by BNDES, to the Ministry of Health. 

The Ministry of Health will be responsible for addressing the projects to BNDES, after analysis and approval with at least the following items: 
1. adherence of the operation objectives to the investment plan generated at the First Phase of PROFARMA- Public Producers 
2. physical-financial schedule; 
3. statement of uses and sources; 
4. administrative and managerial capacity of the applicant to financing; 
5. accomplishment to the standards established to become a beneficiary of the financing (supply of drugs to SUS and realization or absorption of R&D within the last five years); 
6. in case of research and development projects, a statement that the applicant Public Laboratory has a confirmed qualification for realization or absorption of the project's results; 
7. for BPF and BPL projects, presentation of ANVISA's "INSPECTION REPORT"; and 
8. confirmation that the investments or expenses related to 20% of contrapart funds are included in the budgets of the Ministry of Health, State or Municipal Secretariats. 



» Addressing

Financial support requests should be forwarded to:

Banco Nacional de Desenvolvimento Econômico e Social - BNDES
Área de Planejamento-AP
Departamento de Prioridades-DEPRI
Av. República do Chile, 100 - Protocolo - Térreo
20031-917 - Rio de Janeiro, RJ



See:

PROFARMA
PROFARMA-Production 
PROFARMA-Exports
PROFARMA-Innovation 
PROFARMA-Restructuring   
PROFARMA-Public Producers.


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