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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1997 ACT 399

(August 19)

Official Journal No. 43.111., dated August 21, 1997

For which a fee is created, a fee is set and the National Institute of Drug and Food Surveillance, "Invima", is authorized.

COLOMBIA CONGRESS

DECRETA:

ARTICLE 1o. CREATION OF THE LEVY. A fee is established to recover the costs of the services provided by the National Institute of Drug and Food Surveillance, Invima, a body competent to issue Sanitary Records, for the production, import or marketing of medicinal products, biological products, foodstuffs, beverages, cosmetics, medical devices and medical devices, dental products, natural products, homeopathic products and those generated by biotechnology, diagnosis and others that may have an impact on individual and collective health.

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ARTICLE 2o. ACTIVE ETO. The active subject of the levy or contribution will be the National Institute of Drug and Food Surveillance, -Invima-, public establishment, attached to the Ministry of Health.

The Invima will collect this rate directly or through other entities.

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ARTICLE 3o. TAXABLE PERSON. The payment of the fee or contribution created by this law shall be in charge of the natural or legal person who requires the issue, modification and renewal of the sanitary register to produce, import, distribute or market medicines, biological products, food, beverages, cosmetics, medical devices and medical devices, dentistry, natural products, homeopathic products and those generated by biotechnology, diagnostic reagents and other products that may have impact on individual and collective health, in accordance with the provisions of Law 100 of 1993 and other legal provisions.

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ARTICLE 4. OPERATIVE EVENTS. They are made out of the rate set out in this law, the following:

(a) The issuance, modification and renewal of the records of medicinal products, biological products, food, beverages, cosmetics, medical devices and medical devices, dentistry, natural products, homeopathic and those generated by biotechnology, diagnostic reagents and others that may have an impact on individual and collective health;

b) The issue, renewal and extension of the capacity of laboratories, factories or establishments producing, distributing and marketing medicines, biological products, food, beverages, cosmetics, devices and elements surgical, dental, natural, homeopathic and biotechnology-generated medical, diagnostic reagents and other medical devices that may have an impact on individual and collective health;

c) conducting laboratory tests and other expenses that are required to control the quality of the drugs, biological products, food, beverages, cosmetics, devices, and surgical, dental, medical devices, natural, homeopathic and biotechnology-generated products, diagnostic reagents and other products that may have an impact on individual and collective health;

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d) The issuance of records related to records;

e)

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ARTICLE 5o. BASIS FOR THE SETTLEMENT OF THE CHARGE. The basis for the settlement of the fee shall be the cost of the services corresponding to each of the operative events defined in the previous article.

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ARTICLE 6o. METHOD FOR THE DETERMINATION OF TARIFFS. The following technical guidelines will be adopted for the fixing of the charges that will be charged as recovery of the costs of services provided by the Entity, taking into account the total costs and the costs of the technology programs. The tariffs will be set at current daily legal minimum wages.

The National Institute of Drug and Food Surveillance, Invima, will use the following technical guidelines to set the rates for each of the services provided:

a) Elaboration and normalization of flujograms for different processes for the purpose of determining their routines;

b) Quantification of materials and supplies and other technological and human resource inputs, used, annually, in each of the processes and procedures defined in the previous literal. These inputs should include a percentage of the general management costs of the Invima, quantified according to accepted standards and principles of cost accounting;

c) Market price valuation of the inputs described in the previous literal for each of the processes and procedures. Where one of the procedures is to be contracted with third parties, the value of the contracted service shall be taken;

(d) Assessment of the human resource directly used in the provision of the service based on the salaries and benefits of the staff plant of the Invima;

e) Quantification of the costs and programs of technology and modernization of the operation of the services;

f) Estimate of the frequency of use of the rate-generating services.

PARAGRAFO. Both for the definition of procedures and the quantification of costs must be done under maximum efficiency parameters, taking into account the principles set out in the general plan of public accounting.

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ARTICLE 7o. SYSTEM FOR DEFINING THE TARIFF. The system for defining the tariff is a system of standardized costs whose assessments and weightings of the factors involved in its definition are carried out by technically accepted procedures of cost.

The rate for each of the services provided, as listed in Article 4 of this Law, shall be that resulting from adding the value of the inputs and the human resource used, Article 6 (o), (c), (d) and (e) divided by the frequency of use, Article 6o, literal f).

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ARTICLE 8o. DESTINATION OF RESOURCES. The resources collected for this fee will be paid to the Invima to guarantee the fulfillment of its objectives and will be incorporated into its budget in accordance with the provisions of the Organic Law of Budget.

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ARTICLE 9o. TARIFF MANUAL. The following tariff manual is adopted for a period of one year from the date of entry into force of this law.

Health $
Forms Solid pharmaceutical: tablets, grasses, vaginal tablets, capsules, granules, effervescent and non-effervescent 1.1156.209
1002 Forms Liquid pharmaceutical: emulsions, suspensions, syrups, elixirs, solutions, jellies 1.336.192
1003 Forms Liquid pharmaceutical: Injections, powders for reconstructing iofilized 1.196.619
1004 Forms Semi-solid pharmaceutical products: creams, gels, ointments, pastes, eggs, suppositories 1.199.558
1005 Forms Liquid pharmaceutical: ophthalmic and optical solutions 1.081.377
Vaccine Health
1006 Vaccine DPT 1.922.580
1007 Vaccine TD 1.838.224
1008 Vaccine Pertussis 1.337,778
1009 Vaccine VCG 1.557,808
1010 Vaccine anti-rabies 1.335.958
1011 Vaccine antiamarica 1.605.413
1012 Vaccine antisaramponious 1.716.708
1013 Vaccine oral polio 1.633.312
Cosmetic Healthcare
1014 Cremas for face, hands and body 933.462
1015 Cremas depilatory 955,728
1016 Create with sunscreen 1.007.224
1017 Champus and hair rinses 783,969
1018 Tincture for hair 782,991
1019 Ondulators, Alisers, and Hair neutralising 817.226
1020 Fixers for the hair 788.497
1021 Personal hygiene products: deodorants and anti-perspirants 885,627
1022 enamel for nails 855,628
Food health record
2001 Foods enriched with vitamins, minerals and proteins 1.359.455
2002 Entire milk powder added Vitamin A 1.061.057
2003 Meat Derivatives 1.107.498
2004 Fruit Derivatives: Fruit soft drinks, nectars, juices, concentrates, vitamin C added pulps 969,881
2005 Dairy Derivatives 1.232,668
2006 Fishing Derivatives: preserves, semiconservas, and prepared 827.021
2007 Fruit and legumes: preserved fruits, snacks, pickles, jams, jellies 990.982
2008 Cereals and derivatives: flour, arepas, food pastes 1,053,420
2009 Dietary foods and beverages: moisturizers, carbonated 967.131
2010 Stimulant drinks: coffee, tea, mate, aromatic, chocolate, cocoa 891,156
2011 Gaseosas, soft drinks, waters packaged, water ice cream 981,895
2012 sugars and derivatives: sweets, confides, candies, sugar, honey bees 910.515
2013 Specialties, condiments, sauces, dressings, vinegar, mayonnaise, mustard, salt for human consumption 1.128.481
2014 Grases, oils, margarines 907.737
2015 Margarine with Vitamin A 938,830
2016 Licores: spirits, whisky, cognac, brandy, rum, vodka, gin, gyn, tequila, liqueur, creams, anisado liqueur, pisco, raw materials such as alcohols, tafias and spirits
800.312
2017 Wines and appetizers 839.421
2018 Beers 831.556
Health Insured Health Record
3001 Blankers 598,749
3002 Disinfectants in general 560.623
3003 Jeringas Disposable 731,337
3004 Sondas, catheters, venoclysis equipment, surgical susutures, garpas and related 657,970
3005 Gases, algoons, dressings, cures, sparadraps 720.758
3006 Pesticides 1.201.609
3007 Jabons and solid detergents 472.094
3008 detergents liquids 476,724
3009 Panales disposable sanitary pads, towels, and pads 561,809
3010 Producers dentistry 472,873
3011 Usage Resins odontological 479.444
3012 Polymers for denture base 464,469
3013 Alignment for dental amalgams 408.178
3014 Preserving (condoms) 534,906
3015 Blood classification or sera 601.036
3016 Cerologic Technique for lurs (syphilis) 652.295
3017 Diagnostic tests. Hbsag Detection, Hcv 888.232
3018 Diagnostic Test for chagas 743,553
3019 Diagnostic tests. Hiv1/hiv2 detection 881,772
Food and beverage quality
Foods enriched with vitamins, minerals and proteins 828.906
2031 Entire milk powder added Vitamin A 530.508
2032 Meat Derivatives 576,949
2033 Fruit Derivatives: Fruit soft drinks, nectars, juices, concentrates, vitamin C added pulps 439,332
2034 Dairy Derivatives 702.119
2035 Fishing Derivatives: preserves, semiconservas, and prepared 296.472
2036 Fruit and legumes: preserved fruits, snacks, pickles 460.433
2037 Cereals and derivatives: flour, arepas, pasta 522.871
2038 Dietary foods and beverages: moisturizers, carbonated 436.582
2039 Stimulant drinks: coffee, tea, mate, aromatic, chocolate, cocoa 360.606
2040 Gaseosas, soft drinks, bottled water, water ice creams 451.346
2041 sugars and derivatives: sweets, candies, candies, sugar, honey bees 479.966
2042 Species, seasonings, sauces, dressings, vinegar, mayonnaise, mustard, salt for human consumption 597.932
2043 Grases, oils, margarines 377,188
2044 Margarine with Vitamin A 408.280
2045 Licores: spirits, whisky, cognac, brandy, rum, vodka, gin 269,763
2046 Wines and appetizers 308,872
2047 Beers 301.007
2048 Envases and packaging 509.817
2049 Analysis of raw materials, additives, other 286,979
2050 Analysis of vitamins (value per c/u) 312.530
2051 Analysis of mycotoxins (value per c/u) 240.591
2052 Analysis of metals by atomic absorption (value per c/u) 244,909
2053 Analysis of Atomic absorption graphite furnace metal traces (value per c/u) 189,619
2054 Analysis several (dyes, preservatives, alcoholic strength) 216.826
2055 Determination Chlorinated pesticide residues, phosphorated 1.008,667
2056 Analysis food microbiological 336.331
2057 Analysis special microbiological 187.630
2058 Analysis microscopic food 225.093
2059 Liquid Milk sanitized 536.206
Other procedures
4001 Modification health record 43,377
4002 Certifications and authorizations 14.240
4003 Good Vistos import and export 10.794
4004 Authorizations 11,999
4005 Copies authentic case of the case for each sheet 823
4006 Good manufacturing practices for drugs 2.794,725
4007 Certificates Technical production capacity for drugs 26,604
4008 Certificates Capacity for good manufacturing practices for medicinal products 85,536
4009 Certificates The existence of a drug establishment 163.022

PARAGRAFO. These rates will be updated annually by the National Institute of Drug and Food Surveillance, Invima, in accordance with the method and system defined in this law.

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ARTICLE 10. resources collected by the Invima in the development of this law are complementary to the resources with which the State must finance the entity in compliance with the objectives set out in the article 245 of the 100 Act of 1993.

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ARTICLE 11. REINVERSION. The resources that the Invima captures in compliance with this law, will be reinvested in the inspection and surveillance activities that compete with the Invima.

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ARTICLE 12. PAYMENT OF THE FEE. The user will credit the payment of the fee established at the time of filing with the Invima.

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ARTICLE 13. HEALTH RECORDS. The Health Records shall be in force in accordance with the terms laid down in the relevant rules.

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ARTICLE 14. VALIDITY. This law applies as of the date of its publication.

The President of the Honorable Senate of the Republic,

AMYLKAR ACOSTA MEDINA.

The Secretary General of the honorable Senate of the Republic,

PEDRO PUMAREJO VEGA.

The President of the honorable House of Representatives,

CARLOS SQUIRLA BALLESTEROS.

The Secretary General of the honorable House of Representatives,

DIEGO VIVAS TAFUR.

COLOMBIA-NATIONAL GOVERNMENT

Publish and execute.

Dada en Santa Fe de Bogotá, D. C., on August 19, 1997.

ERNESTO SAMPER PIZANO

The Minister of Finance and Public Credit,

JOSE ANTONIO OCAMPO GAVIRIA.

The Minister of Health,

MARIA TERESA FORERO DE SAADE.

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