For Which A Rate Is Created, Tariffs Are Fixed And Authorizes The National Institute Of Food And Drug Monitoring, "invima" His Collection

Original Language Title: Por la cual se crea una tasa, se fijan unas tarifas y se autoriza al Instituto Nacional de Vigilancia de Medicamentos y Alimentos, "Invima", su cobro

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ACT 399 OF 1997
(August 19)
Official Gazette No. 43,111., Of 21 August 1997
By which a rate is created, tariffs are fixed and authorizes the National Institute Surveillance Food and Drug Administration, "Invima" collection.

THE CONGRESS OF COLOMBIA DECREES:
ARTICLE 1o. CREATION OF RATE. It is establishing a levy to recover the costs of services provided by the National Institute of Drug Surveillance and Food, Invima, the body responsible for issuing health records, for the production, import or marketing of drugs, biological products, food, beverages , cosmetics, medical devices and surgical items, dental natural, homeopathic products and those generated by biotechnology, diagnostic reagents and others that may have impact on individual and collective health.
Article 2.
. BOUND ACTIVE. The active subject or contribution rate will be the National Institute of Food and Drug Monitoring, INVIMA, public institution under the Ministry of Health.
The Invima raise this rate directly or through other entities.

ARTICLE 3o. PASSIVE SUBJECT. The payment of the fee or contribution created by this law will be in charge of the natural or legal person requesting issuance, amendment and renewal of health registration to produce, import, distribute or sell drugs, biological products, food, beverages, cosmetics, surgical devices and medical items, dental, natural, homeopathic products and those generated by biotechnology, diagnostic reagents and others that may have impact on individual and collective health, in accordance with the provisions of Law 100 of 1993 and other legal provisions .
ARTICLE 4.
. FACTS GENERATORS. They are made generators rate set forth in this law, the following:
a) The issuance, amendment and renewal of registration of medicines, biological products, food, beverages, cosmetics, devices and surgical, dental, medical items, natural, homeopathic and those generated by biotechnology, diagnostic reagents and others that may have an impact on individual and collective health products;
B) The issuance, renewal and expansion of the capacity of laboratories, factories or production facilities, distribution and marketing of drugs, biological products, food, beverages, cosmetics, devices and surgical, dental, medical products natural elements, homeopathic and those generated by biotechnology, diagnostic reagents and others that may have impact on individual and collective health;
C) Carrying out laboratory tests and other expenses required to control the quality of drugs, biological products, food, beverages, cosmetics, medical devices and surgical items, dental, natural, homeopathic and those generated by biotechnology, diagnostic reagents and others that may have impact on individual and collective health; Effective Jurisprudence


D) The issuance of certificates related to records;
E) Effective Jurisprudence

Legislation Previous


The 5th ARTICLE. BASE CLOSURE FOR RATE. The basis for the settlement of the rate will be the cost of services for each one of the operative events as defined in the preceding article.
ARTICLE 6.
. METHOD FOR DETERMINING THE RATES. the following technical guidelines for fixing rates to be charged as cost recovery of services provided by the Bank shall be adopted, taking into account the total operating costs and costs of modernization programs. Rates are fixed in daily legal minimum wage.
The National Institute of Food and Drug Monitoring, Invima, use the following technical guidelines for setting tariffs for each of the services provided:
a) Development and standardization of flowcharts for different processes for the purpose of determine their routines;
B) Quantification of materials and supplies and other technological inputs and human resources used annually in each of the processes and procedures defined in the preceding paragraph. These inputs must include a percentage of the costs of general administration of Invima, quantified according to the rules and principles accepted cost accounting;
C) Valuation at market prices of inputs described in the preceding paragraph for each of the processes and procedures. When one of the procedures should be contracted out to third parties, the value of the service will be taken;

D) Assessment of human resources used directly in the service based on the wages and benefits of plant personnel Invima;
E) Quantification of costs and modernization programs and modernizing the operation of services;
F) Estimation of frequency utilization rate generating services.
PARAGRAFO. Both procedures for defining and quantifying the costs should be made within the parameters of maximum efficiency, taking into account the principles established in the general plan of public accounting.

Article 7. SYSTEM TO DEFINE THE RATE. The system for defining the rate is a system whose costs be standardized assessments and weightings of the factors involved in its definition are performed by technically accepted costing procedures.
The rate for each of the services listed in the article 4 of this law, will be calculated by adding the value of inputs and human resources used, Article 6, paragraphs c), d) and e) divided by the frequency of use, Article 6, paragraph f).
ARTICLE 8.
. DESTINATION OF RESOURCES. The resources collected by way of this fee will enter the Invima to ensure compliance with its objectives and will be incorporated into the budget in accordance with the provisions of the Organic Budget Law.

Article 9. MANUAL FOR RATES. The following manual rates are adopted for a period of one year, counted from the date of entry into force of this law.
Health records medicamentosTarifa $
solid pharmaceutical 1001Formas: tablets, coated tablets, vaginal tablets, capsules, granules, effervescent and not efervescentes1.1156.209
liquid pharmaceutical 1002Formas: emulsions, suspensions, syrups, elixirs, solutions, jaleas1
.336.192 liquid pharmaceutical 1003Formas: injectables, powders to rebuild iofilizados1.196.619
semisolid pharmaceutical 1004Formas: creams, gels, ointments, pastes, lozenges, suppositories 1,199,558
liquid pharmaceutical 1005Formas: ópticas1 and ophthalmic solutions. 081,377
Health immunization records 1006Vacuna DPT1.922.580


1007Vacuna TD1.838.224 1008Vacuna Pertussis1.337.778 1009Vacuna VCG1.557.808


1010Vacuna antirrábica1.335.958 1011Vacuna antiamarílica1.605.413
1012Vacuna antisarampionosa1.716.708 1013Vacuna

oral polio 1633312 sanitary registration of cosmetics
1014Cremas for face, hands and depilatory cuerpo933.462 1015Cremas

1016Cremas 955,728 1,007,224 sunscreen 1017Champús
and
rinses cabello783.969 1018Tintura for cabello782
.991 1019Onduladores, straighteners and hair neutralizing 1020Fijadores 817,226

cabello788.497 1021Productos for personal hygiene: deodorants and antiperspirants 885 627 855 628

nail 1022Esmalte health food registration
2001Alimentos fortified with vitamins, minerals and proteínas1.359.455
2002Leche whole powder added vitamin A 1,061,057 1,107,498

meat 2003Derivados 2004Derivados fruit: fruit drinks nectars, juices, concentrates, pulps spiked vitamin C 1,232,668 969,881 dairy 2005Derivados

fishing 2006Derivados: canned and prepared 827,021
semi 2007Frutas and vegetables: canned fruit, sandwiches, pickles, jams, jellies 990,982
2008Cereales and derivatives: flour, arepas, pasta 1,053,420
2009Alimentos and diet drinks: moisturizing, carbonated 967,131
2010Bebidas stimulants: coffee, tea, mate, aromatic, chocolate, cocoa 891156
2011Gaseosas, soft drinks, bottled water, water ices 981,895
2012Azúcares and derivatives candy, candy, candy, sugar, honey 910,515
2013Especias, seasonings, sauces, dressings, vinegar, mayonnaise, mustard, 1128481 salt for human consumption
2014Grasas, oils, margarinas907.737 2015Margarina

vitamin A 938,830 2016Licores: brandy, whiskey, cognac, brandy, rum, vodka, gin, gyn, tequila, liquor, creams, aniseed liquor, pisco, raw materials such as alcohols, tafia and spirits and snacks 2017Vinos
800,312 839,421 831,556 2018Cervezas

Health Register of Health Products

3001Blanqueadores 598,749 560,623 3002Desinfectantes general

3003Jeringas desechables731.337 3004Sondas, catheters, infusion devices, surgical susuturas, garpas and afines657.970
3005Gasas, cottons , bandages, dressings, esparadrapos720.758 3006Plaguicidas1.201.609


3007Jabones and detergents sólidos472.094 3008Detergentes líquidos476.724
3009Pañales disposable towels and protective sanitarios561.809
3010Productores odontológicos472.873


3011Resinas use odontológico479.444 3012Polímeros for dentadura464.469 base for dentales408.178 amalgams 3013Alineaciones

3014Preservativos (condoms) 534,906

3015Clasificación blood or sueros601.036 3016Técnica cerológica for lurs (syphilis) 652,295
diagnostic 3017Pruebas. HBsAg detection, diagnosis Hcv888.232

chagas743.553 3018Prueba for diagnostic 3019Pruebas. Detection HIV1 / hiv2881.772
Certificates of quality food and beverage
2030Alimentos fortified with vitamins, minerals and proteínas828.906
2031Leche whole vitamin powder added A530.508

2032Derivados cárnicos576.949 2033Derivados fruit: soft drinks fruit nectars, juices, concentrates, pulps spiked vitamin C439.332

2034Derivados lácteos702.119 2035Derivados of fishing preserves, semi and preparados296.472
2036Frutas and vegetables: canned fruit, sandwiches,
encurtidos460.433 2037Cereales and derivatives: flour, arepas, pastas alimenticias522.871
2038Alimentos and diet drinks: moisturizing, carbonatadas436.582
2039Bebidas stimulants: coffee, tea, mate, aromatic, chocolate, cocoa360.606
2040Gaseosas, soft drinks, bottled water, ice agua451.346
2041Azúcares and derivatives sweets, candies, candy, sugar, honey abejas479.966
2042Especias, seasonings, sauces, dressings, vinegar, mayonnaise, mustard, salt for consumption humano597.932
2043Grasas, oils, vitamin 2044Margarina margarinas377.188

A408.280 2045Licores: brandy, whiskey, cognac, brandy, rum, vodka, ginebra269.763
2046Vinos and aperitivos308.872 2047Cervezas301.007


empaques509.817 2049Análisis 2048Envases and raw materials, additives, vitamins otros286.979
2050Análisis (value c / u) 312,530
2051Análisis mycotoxin (value c / u) 240,591
2052Análisis of metals by atomic absorption (value c / u) 244,909
2053Análisis of trace metals by graphite furnace atomic absorption (value c / u) 189619
several 2054Análisis (dyes, preservatives, alcohol content)
216,826 2055Determinación chlorinated pesticides residues, microbiological fosforados1.008.667 2056Análisis of alimentos336.331


especiales187.630 2057Análisis microbiological microscopic 2058Análisis of alimentos225.093 2059Leche liquid higienizada536.206

Other registration procedures sanitario43.377

4001Modificación 4002Certificaciones and autorizaciones14.240
good 4003Vistos import and exportación10.794

publicidad11.999 4004Autorizaciones of 4005Copias authentic record for each hoja823
4006Buenas manufacturing practices for medicamentos2.794.725
4007Certificados technical production capacity to medicamentos26.604
4008Certificados capacity of good manufacturing practices medicamentos85.536
existence 4009Certificados capacity setting medicamentos163.022
PARAGRAFO. These rates are updated annually by the National Institute of Food and Drug Monitoring, Invima, according to the method and defined in this law system. Effective Jurisprudence

ARTICLE 10.
revenues of INVIMA. The resources collected by the developing Invima of this law, are a complement to the resources with which the state must finance the entity in pursuit of the objectives set out in Article 245 of Law 100 of 1993
Article 11.
REINVESTMENT. The resources that captures the Invima in compliance with this law, will be reinvested in inspection and surveillance activities that fall to Invima.

ARTICLE 12. PAYMENT RATE. You credit the payment rate established at the time of filing their application before the Invima.

ARTICLE 13. EFFECTIVE health records. Health Records shall be valid according to the terms set by current regulations on the matter.

ARTICLE 14. EFFECTIVE DATE. This law applies from the date of publication.
The President of the Senate of the Republic,
Amylkar ACOSTA MEDINA.
The Secretary General of the honorable Senate,
PUMAREJO PEDRO VEGA.
The President of the honorable Chamber of Representatives,
CARLOS ARDILA BALLESTEROS.
The Secretary General of the honorable House of Representatives, DIEGO VIVAS
TAFUR.
REPUBLIC OF COLOMBIA - NATIONAL GOVERNMENT
published and execute.
Given in Santa Fe de Bogota, DC, on August 19, 1997.

Ernesto Samper Pizano Minister of Finance and Public Credit, JOSE ANTONIO OCAMPO
Gaviria.
The Minister of Health, MARIA TERESA
SAADE Forero.