1997 ACT 399
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.
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.
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.
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.
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;
d) The issuance of records related to records;
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.
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.
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).
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.
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.
|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|
|1013||Vaccine oral polio||1.633.312|
|1014||Cremas for face, hands and body||933.462|
|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|
|2004||Fruit Derivatives: Fruit soft drinks, nectars, juices, concentrates, vitamin C added pulps||969,881|
|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||
|2017||Wines and appetizers||839.421|
|Health Insured Health Record|
|3002||Disinfectants in general||560.623|
|3004||Sondas, catheters, venoclysis equipment, surgical susutures, garpas and related||657,970|
|3005||Gases, algoons, dressings, cures, sparadraps||720.758|
|3007||Jabons and solid detergents||472.094|
|3009||Panales disposable sanitary pads, towels, and pads||561,809|
|3011||Usage Resins odontological||479.444|
|3012||Polymers for denture base||464,469|
|3013||Alignment for dental amalgams||408.178|
|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|
|2033||Fruit Derivatives: Fruit soft drinks, nectars, juices, concentrates, vitamin C added pulps||439,332|
|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|
|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|
|4001||Modification health record||43,377|
|4002||Certifications and authorizations||14.240|
|4003||Good Vistos import and export||10.794|
|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.
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.
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.
ARTICLE 12. PAYMENT OF THE FEE. The user will credit the payment of the fee established at the time of filing with the Invima.
ARTICLE 13. HEALTH RECORDS. The Health Records shall be in force in accordance with the terms laid down in the relevant rules.
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.
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.