Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplem ents 
EXECUTIVE DECREE No  
THE PRESIDENT OF THE REPUBLIC  
AND THE MINISTER  OF HEALTH  
On the basis of the powers vested in them by Articles 50, 140(3) and (18) and 146 of the 
Political Constitution; Articles 27(1)  and 28(2)(b) of Act No  6227 of 2  May 1978 and the 
Ley General de la Administración Pública  (General Public Administration Act) and in 
accordance with the provisions of the Ley General de Salud  (General Health Act) and its 
amendments,  Act No  5395 of 30  October  1973   
WHEREAS  
1. It is an essential function of  the State to ensure that public health  is protected . 
2. The State is also responsible for ensuring citizens' welfare without unnecessary  
impairment of  the competitiveness needed for development of  the national 
economy . 
3. There are a growing number of pro ducts marketed as foodstuffs that contain high 
concentrations of nutrients and other ingredients and are intended to supplement 
the ingestion of such substances  as part of a normal diet . 
4. It is necessary for health  registration purposes to classify such products as dietary 
supplements and also to set requirements regarding their composition, labelling 
and marketing in such a way as to promote the correct use of such products by the 
general public.  
THEREFORE  
DECREE  
Article 1  That they approve the following  Regulation:  
COSTA RICAN TECHNICAL REGULATION (RTCR) NO  436:2009:  DIETARY 
SUPPLEMENTS.  REQUIREMENTS PERTAINING TO HEALTH  
REGISTRATION, IMPORTATION, CUSTOMS CLEARAN CE, LABELLING 
AND VERIFICATION  
1. Purpose and area of application  
The purpose of this Regulat ion is to lay down  the conditions and requirements for the 
health  registration, importation, customs  clearance, labelling and verifica tion of food 
supplements.  
This Regulation shall apply to all dietary supplements that are marketed in this country . 
2. Ref erences  
This Regulation is complemented by:  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
1. Decreto Ejecutivo  (Executive Decree) No  26012 -MEIC, Costa Rican Technical 
Regulation (RTCR) No  100:1997:  Etiquetado de los Alimentos Preenvasados (Labelling 
of pre -packaged foods ), published in La Gaceta  (Offi cial Gazette ) of 16 April 1997.  
 
2. Executive Decree No  30256-MEIC -S, RTCR No  135:2002: Etiquetado Nutricional 
de los Alimentos Preenvasados (Nutrition labelling of pre -packaged food), published in 
the Official Gazette  of 15  April  2002.  
 
3. Executive Decre e No  34728 -S, Reglamento General para el Otorgamiento de 
Permisos de Funcionamiento por parte del Ministerio de Salud  (General regulations 
governing the issuing of operating permits by the Ministry of Health), published in the 
Official Gazette  of 9 Septemb er 2008.  
 
4. Executive Decree No  33724, Central American Technical Regulation (RTCA) 
No 67.01.30:06:  Alimentos Procesados.  Procedimiento para otorgar la licencia sanitaria 
a fábricas y bodegas (Processed foods.  Procedure for granting health  licences to fac tories 
and warehouses), published in the Official Gazette  of 30 April 2007.  
3. Definitions  
The following definitions shall apply for the purposes of implementing this Regulation:  
3.1 Energy drinks: Non-alcoholic drinks marketed as such that contain  any of the 
following ingredients: taurine, glucuronolactone, caffeine, inositol, carbohydrates, 
vitamins, minerals or other ingredients added to this list by means of an administrative 
decision taken by the Ministry and published in the Off icial Gazette . 
3.2 Cert ificate of good manufacturing practice : The document issued by the health 
authority of the country of origin certifying that the manufacturer of the supplement in 
question duly meets the good manufacturing practice requirements applicable to dietary 
supple ments.  
3.3 Free sale and consumption certificate : The document issued by the competent 
authority of the country of origin  and duly certified by the Consulate , stating that the sale 
of the food supplement is legally authorised for human consumption in that country and 
indicating the date up to which the registration  or authorisation remains in force.  
3.4 Confiscation : Loss of ownership to the State by the owner of products that have 
caused or resulted in a health infringement or are harmful or hazardous to h uman health. 
The health authorities will, on their own authority, confiscate dietary supplements that 
are obviously spoiled, contaminated, adulterated or counterfeited.  
3.5 Special health measures : Measures that may be taken by the health authorities in 
order to effectively protect public health by preventing the appearance of hazards and the 
exacerbation and spread of damage and the continuation or recurrence of legal or 
regulatory infringements that impair  human health. Withholding and withdrawing from 
the market or circulation, confiscation, denaturing, destruction of assets, closure of 
establishments and the cancellation of permits and registrations are deemed to be special 
measures.  
3.6 Ministry : Ministry of Health.  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
3.7 Sampling : Procedure for taking th e dietary supplement samples necessary to verify 
compliance with the provisions of this Regulation.  
3.8 Sample of no commercial value : Substances or products that do not exceed the total 
import amount for customs purposes specified in t he customs legislati on in force and are 
generally intended  for product promotion purposes are regarded as samples of no 
commercial value.  
3.9 Customs clearance permit : Authorisation granted by the competent goods clearance 
authority.  
3.10 Health permit : Advance administrative  authorisation granted by the Ministry of 
Health to any natural or legal person importing, manufacturing or dealing in dietary 
supplements under a  particular name and  trademark  into or in the territory of this  country 
in accordance with the provisions of t he General Health Act and the regulations 
applicable to the various economic activities.  
3.11 Health  registration : The process by which the Health Authority authori ses the 
marketing of a dietary supplement in response to an application submitted together w ith 
the documentation necessary  for its assessment, statistical registration and subsequent 
monitoring.  
3.12 Legal representative : The natural or legal person resident in Costa Rica , 
designated by the owner of the dietary supplement by means of a power of attorney, who 
is responsible to the regulatory authority.  
3.13 Withholding : Keeping dietary supplements of doubtful composition or condition in 
a safe environment under the seal of the health authority where there are groun ds for 
suspecting that their use  or consumption might be harmful or hazardous to health , and in 
so doing prohibiting their transportation, use or consumption  until the corresponding tests 
to determine their composition or condition have been carried out.  
3.14 Withdrawal from the market or  circulation : The full or partial withdrawal of 
consignments or batches of dietary supplements found to be in contravention of  the 
regulatory requirements they need to meet in order to be marketed or the use or 
consumption of which has  been found to be harmful or hazardous to public health , such 
withdrawal being incumbent on the owner, director or legal  representative of the 
company, who must duly and scrupulously carry it out.  
3.15 Dietary supplement : A product intended to supplement the diet for health re asons, 
to help to maintain and protect certain physiological states.  It is presented as a 
concentrated source of nutrients and other substances or plants, including ingredients 
such as vitamins, minerals, proteins, amino acids and other nutrients and subst ances 
derived from them . It must have  only a physiological or nutritional , not a therapeutic, 
effect and its consumption must not constitute a health hazard. It may be marketed in 
pharmaceutical form (pills, capsules, syrup, etc.), in measured doses and fo r oral use  
only. Energy drinks shall be deemed  to be dietary supplements for the purposes of this 
Regulation. Foods for special diets shall not be deemed to be covered by this Regulation.  
3.16 Charge: Amount officially established to meet the duties payabl e to enable  
processing, registration and verification to be carried out.  
 3.17 Product owner : The natural or legal person who owns the dietary supplement.  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
 
4. Symbols and abbreviations  
4.1 mg: milligram  
4.2 ml: millilitre  
4.3 g ER: microgram of retinol equivalent  
4.4 g: microgram  
4.5 NOAEL: No observable adverse effect level  
5. Administration of the health  registration of dietary supplements  
The Ministry, through the Dirección de Atención al Cliente  (Customer Service 
Department), shall be responsible for granting, refusing and cancelling the registration of 
dietary supplements.  
6. General aspects of the health  registration of dietary supplements  
Dietary supplements must undergo health  registration in accordance with the 
requirements of this Regulation before they can be marketed, imported or distributed.  
Registration shall not preclude the full liability  of the natural or legal persons who have 
manufactured, produced or imported the food supplement for giving a health gua rantee in 
respect of  the product and ensuring its nutritional value and safety. The Ministry shall 
register  a dietary supplement when it has decided in to approve it  after having analysed 
the legal, technical and scientific information required in each cas e. 
Dietary supplement s amples of no commercial value  are exempted from the registration 
requirement.  
7. Requirements for the health  registration of dietary supplements. Persons wishing 
to effect the health  registration of dietary supplements must submit th e following 
information to the Ministry in a ring file containing numbered sheets and marked with 
the name of the supplement : 
7.1 Registration application form completed and  signed by the applicant or the 
company's legal representative.  
7.2 Copy of the ope rating permit in force. If the product s are to be  imported, the  duly 
authenticated  free sale and  consumption certificate  duly issued by the competent 
authority in the country of origin. It may cover one or more products but must have been 
issued within the  past two years. If the certificate is written in a language other than 
Spanish, it must be accompanied by the respective official translation.  
7.3 Certificate of good manufacturing practice in the case of imported product s. This 
must be duly authenticated  and have  been issued by the competent authority in the 
country of origin. It must have been issued within the past two years. If the certificate is 
written in a language other than Spanish, it must be accompanied by the respective 
official translation.  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
7.4 Valid confirmation of legal status  in the case of legal persons, which must have been 
issued within the past three months.  
7.5 Qualitative and quantitative formula of the product  expressed in units in accordance 
with the Ley del Sistema Internacional de Medidas  (International Measurement System 
Act). In the case of plants, the scientific species name and the part of the plant being used 
must be indicated. If the supplements contain probiotics, the scientific name and 
registration code of the bacteria and the dose contained in the supplement must be shown.  
7.6 Original label or label design in accordance with Regulation (RTCR) No  100:1997: 
Labelling of pre -packaged foods  and its amendments. If this is written in a language 
other than Spanish, the official t ranslation must also be provided.  
7.7 Evidence published in scientific journals of the use (s) of the supplement , unless its 
uses are included  in the list of permitted uses of dietary supplements, to be confirmed by 
the Ministry at a later date.   
7.8 Refere nce to the analysis methodology used to verify the presence of nutrients or 
ingredients of the dietary supplement.  
7.9 Payment of the fixed registration charge according to the provisions of Executive 
Decree No  32468 published in Official Gazette  No 137 of  15 July 2005.  
8. Minimum and maximum concentrations of vitamins, minerals and other 
ingredients  
a) The concentrations of the vitamins and minerals contained in the dietary supplements 
must be no t less than the levels  specified in Annex  1, which correspond  to 20% of the 
RDI in the United States of America.  
b) Dietary supplements m ay not exceed the maximum concentrations of vitamins, 
minerals and other ingredients respectively specified in Annexes 2 and 3.  
9. Completion deadlines  
When the full correct docume ntation has been received, it will be assessed by the 
Customer Service Department within one calendar month.  
If the information that has been supplied needs to be clarified, corrected or supplemented, 
the Authority shall, before the end of the one -month pe riod, issue a single administrative 
decision, duly substantiated in technical and legal terms, requesting the person concerned 
to submit the necessary information  within ten (10) working days. The completion period 
for the public authority shall be extende d by the same amount of time. If  the person 
concerned fails to submit the requested information within this period, the application  
shall be deemed to have been abandoned  and the Ministry shall issue a substantiated 
decision declaring discontinuation of th e application, which shall then be placed on file. 
The respective payment shall not be refunded as a result  of this .  
The Ministry shall resume processing the application as soon as the applicant prov ides 
the requested information . 
10. Validity of health  registration  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
Health  registration shall remain valid for five (5) years  and shall be repeatedly renewable 
on expiry unless the owners are guilty of infringements that justify  its immediate 
cancellation or the registered food supplement constitutes a hazard f or public health in 
the opinion of the health authority.  
11. Renewal of  health  registration  
Health  registration shall be renewed by the same procedure as for initial registration and 
subject to the same requirements , except for the need to submit studies t o substantiate the 
uses of the product shown by the labels, unless there has been a change to the  use 
originally approved . 
12. Changes to health  registration  
If there are changes to the information or the features of a dietary supplement, the person 
respon sible  must apply to the authority for approval of the changes , enclosing the items 
needed for the changes to be processed as listed below. All the documentation must be 
submitted in Castilian Spanish and official documents written in other languages must b e 
submitted with the respective official translation.  
12.1 Change of name of applicant's company  
12.1.1 Legal document certifying the change  
12.1.2 Original legal status of the applicant's company  under its new name , which must 
have been issued within the past three months.  
12.2 Change of manufacturer  
12.2.1 In the case of products manufactured in this country, the Public Authority shall 
verify the validity of the health operating permit of the new manufacturer.  
12.2.2 If the product is manufactured outside  this country, the person concerned must 
submit the Certificate of good manufacturing practice.  
12.2.3 New  label design or original label.  
12.3 Change in the list of ingredients ( excipients only)  
12.3.1 Qualitative and quantitative formula.  
12.4 Transfer o f registration  
12.4.1 Legal document certifying transfer.  
12.5 Change in or extension of the product name or trade mark  
12.5.1 New label design or original label.  
12.6 Change in or extension of the use of the product  
12.6.1 New label design or original lab el. Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
12.6.2 Scientific studies supporting the proposed claim (in accordance with section 7.7 if 
applicable).  
 
13. Labelling requirements  
13.1 Labels for dietary supplements must comply with the provisions of Executive 
Decree No  26012 Technical Regulation on the l abelling of pre -packaged foods , 
published in Official Gazette  No 91 of 14 May  1997 and of Executive Decree No  30256  
Technical Regulation on n utrition labelling of pre -packaged food , published in  Official 
Gazette  No 71 of 15  April  2002 . They must also : 
 
13.1.1 contain true information about the product, which must not be described or 
presented using words, illustrations or other graphical representations that might be 
misleading about the nature, origin, composition or quality of the dietary supplement . 
 
13.1.2 provide details of the composition in dose form. If it includes plants, their 
common and scientific names and the parts of the plants used must be indicated. If the 
supplements contain probiotics, the scientific name and registration code of the bacteria 
and the dose contained in the supplement must be shown. The appropriate measurement 
units according to the International Measurement System Act must be used to declare 
ingredient quantities.  
 
13.1.4 show the recommended maximum daily consumption  of the dietary supplement in 
its commercial form.  
 
13.1.5 include the following statements or equivalent phrases:  
 
a) "THIS PRODUCT MUST NOT BE USED TO DIAGNOSE, TRE AT, CURE OR 
PREVENT ANY ILLNESS NOR AS A SUBSTITUTE FOR A BALANCED DIET";  
 
b) "NOT FOR USE BY PREGNANT OR BREASTFEEDING WOMEN OR BY 
CHILDREN" , except in the case of products specially intended  for such persons, which 
must then bear the statement: "USE UNDER MEDICAL SUPERVISION";  
 
c) "KEEP OUT OF THE REACH OF CHILDREN";  
 
d) Dietary supplements th at contain tartrazine or FD&C Yellow No  5 must indicate that 
they contain this colouring and bear the statement: "CONTAINS TARTRAZINE OR 
FD&C YELLOW NO FIVE, WHICH MAY CAUSE ALLERGIC REACTIONS IN 
SENSITIVE PERSONS";  
 
e) Dietary supplements containing the s weetener aspartame must bear the statement: 
"PHENYLKETONURICS – CONTAINS PHENYLALANINE";  
 
f) Energy drinks containing caffeine must show the quantity of this ingredient they 
contain and bear the statement:  
 
"CONSUMPTION OF THIS PRODUCT BY PERSONS SENSITIVE  TO CAFFEINE IS 
NOT RECOMMENDED" ; Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
g) In addition, labels for energy drinks must bear the following statements:  
"CONSUMPTION OF THIS DRINK MIXED WITH ALCOHOL IS HARMFUL TO 
HEALTH".  
If the original labels of imported products do not include the compulsory st atements, it is 
acceptable for the importer to include them in an additional label.  
14. Importation and customs clearance  
Dietary supplements can be cleared through customs only after verification that  the 
product is duly registered with the Ministry.  
15. Verification  
The Ministry shall be the body responsible for enforcement and verificati on of this 
Technical Regulation  and may therefore carry out inspections and take samples for 
quality analysis and control purposes on the market, at customs points and on  the 
premises of domestic manufacturers and other authorised establishments.  If the product 
contains an  ingredient  or additive  that cannot be analysed in this country, the 
manufacturer or importer must furnish a product analysis certificate issued by the h ealth 
authority in the count ry of origin or a laboratory recognised by it.  
16. Application of special measures  
If statements made for the purposes of registration with the Ministry are shown not to 
have been complied with or to be incorrect, the health aut hority shall withhold or 
confiscate the product in question or withdraw it from circulation or its registration sh all 
be cancelled as appropriate, after notification of the legal representative, who must pay 
the costs of the health measures taken.  
The Mini stry, under the legislation in force and  the principles of fundamentally 
guaranteeing due process, may cancel registration or authorisation for customs clearance, 
particular ly in the following cases:  
a) existence of domestic or international health warning s justifying such action;  
b) failure to comply with the requirements shown on the label;  
c) if it is shown that the conditions under which health registration was granted have not 
been complied with . 
The health authority shall apply these special measures on the basis of the provisions of 
Article  386 of the General Health Act without prejudice to the civil or criminal liability 
incurred by the natural or legal persons responsible for such non -compliance or to any 
other penalties applicable under the legisla tion in force.  
17. CONFORMITY  
This Regulation does not conform with any other standards or regulations.  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
18. BIBLIOGRAPHY  
1. Agencia Nacional de Vigilancia Sanitaria  (National Health Surveillance Agency 
(ANVISA). Brazil. Regulamento Técnico para fixação de  identidade e qualidade do 
composto liquido pronto para consumo . (Technical Regulation for identifying and 
determining the quality of liquid substances ready for consumption). Ordinance No  868 
of 3 November  1998. (DOU.  DE 05/11/98). Available at 
http://www.anvisa.gov.br/legis/portarias/868_98.htm . Consulted on 21  July 2008.  
2. Agencia Nacional de Medicamentos, Alimentos y Tecnología Médica  (National Drugs, 
Foods and Medical Technology Agen cy) (ANMAT). Código Alimentario Argentino  
(Argentine Food Code), Chapter XVII, Alimentos de Régimen o Dietéticos  (Dietary and 
dietetic foods). Available at  http://www.anmat.gov.ar/codigoa/caa 1.asp . Consulted on 
17 May 2008.  
3. Comisión del Codex Alimentarius ( Code x Alimentarius  Committee). 2005. Directrices 
para complementos alimentarios de vitaminas y/o minerals  (Guidelines for vitamin 
and/or mineral food supplements). CAC/GL  55 – 2005.  
4. Congres s of the United States of America. 1994. Dietary Supplement Health and 
Education Act of 1994. Public Law 103 -417. 103rd Congress.  
5. Electronic Code of Federal Regulations. 2008. RDI's for vitamins and minerals. 
Available at http://www.gpoaccess.gov/ecfr/ . Consulted in October 2008.  
6. Hathcock , JN. Ph. D. 2004. Safety of vitamin and mineral supplements. Safe levels 
identified by risk assessment.  
7. Ministerio de Salud de la República de Chile  (Ministry of Hea lth of the Republic of 
Chile). Reglamento Sanitario de los Alimentos  (Health Regulation relating to Food). 
Decree  No 977/96 (Of ficial Gazette  13.05. 97). Section XXIX. De los Suplementos 
Aliment arios y de los Alimentos para Deportistas  (Concerning food supp lements and 
foods for persons engaging in sport). Updated August 2006.  
8. Ministerio de la Protección Social  (Ministry of Social Protection), Republic of 
Colombia. 2006. Decree No 3249. Fabricación, comercializaci ón, envase, rotulado o 
etiquetado, regimen de registro sanitario, de control de calidad, de vigilancia sanitaria y 
control sanitario de los suplementos dietarios  (Manufacture, marketing, packaging, 
marking or labelling, health  registration, quality control, health surveillance and health 
monitoring  system for dietary supplements. Diario Oficial  (Official Gazette ) No 46395 
of 18  September  2005.  
9. Directive 2002/46/EC of the European Parliament and of the Council of 10  June 2002 
on the approximation of the laws of the Member States relating to food s upplements.  
10. Secretaria de Salud ( Ministry of Health ), United States of Mexico. 1999. Reglamento 
de Control Sanitario de Productos y Servicios (Regulation concerning the health 
inspection of goods and services). Section nineteen, Suplementos alimenticio s (Food 
supplements).  
11. Secretaria de Salud ( Ministry of Health ), United States of Mexico. 1998. Reglamento 
de Insumos para la Salud (Regulation concerning healthcare products ). Chapter IV. 
Medicamentos Vitamínicos  (Healthcare products  containing vitamin s). Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
Annex 1  
Minimum daily  concentrations of vitamins and minerals in dietary supplements  
(Regulatory standards ) 
Vitamin  Units  Quantity  
g ER  300 A 
UI 1 000  
C mg 12 
g 2 D 
UI 80 
mg 4 E 
UI 6 
K g 16 
Thiamine (B1)  mg 0.3 
Riboflavin (B2)  mg 0.34 
Niacin  mg 4 
Pyridoxine (B6)  mg 0.4 
Folic acid  g 80 
Cyanocobalamin (B12)  g 1.2 
Biotin  g 60 
Pantothenic acid  mg 2 
 
Mineral  Units  Quantity  
Calcium  mg 200 
Iron mg 3.6 
Phosphorus  mg 200 
Magnesium  mg 80 
Zinc mg 3 
Iodine  g 30 
Selenium  g 14 
Copper g 0.4 
Manganese  mg 0.4 
Chromium  g 24 
Molybdenum  g 15 
 
Source: Electronic Code of Federal Regulations. RDI's for vitamins and minerals. 
Available at http://www.gpoaccess.gov/ecfr/ . Consulted in Octob er 2008.  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
Annex 2  
Max imum daily  concentrations of vitamins and minerals in dietary supplements  
(Regulatory standards ) 
Vitamin  Units  NOAEL  
g  3 000  A 
UI 10 000  
Beta-carotene  mg 25 
C mg 2 000  
g 60 D 
UI 2 400  
mg 1 000  E 
UI 1 490  
K mg 10 
Thiamine (B1)  mg 100 
Riboflavin (B2)  mg 200 
Niacin  mg 35 
Pyridoxine (B6)  mg 100 
Folic acid  g 1 000  
Cyanocobalamin (B12)  g 3 000  
Biotin  mg 2.5 
Pantothenic acid  mg 1 000  
 
Mineral  Units  NOAEL  
Calcium  mg 2 500  
Phosphorus  mg 4 000  
Magnesium  mg 400 
Potassium  mg 1 500  
Boron  mg 20 
Chromium  g 1 000  
Copper  mg 10 
Fluoride  mg 10 
Iodine  g 1 100  
Iron mg 60 
Manganese  mg 10 
Molybdenum  g 2 000  
Selenium  g 400 
Zinc mg 40 
Selenium  g 400 
 
Source: John N. Hathcock, Ph.D. Safety of vitamin and mineral supplements. Safe 
levels identified by risk assessm ent. April 2004.  Decree No    Regulation on Health Registration, Importation, Customs Clearance, 
Labelling and Verification of Dietary Supplements  
Annex 3  
Maximum concentrations by volume  of a number of substances normally contained 
in energy drinks  
(Regulatory standards)  
TAURINE: 400 mg/100  ml 
GLUCURONOLACTONE: 250 mg/100 ml  
CAFFEINE: 35 mg/100 ml  
 INOSITOL: 20 mg/100 ml  
 
Sourc e: National Health Surv eillance Agency (ANVISA) . Technical Regulation for 
identifying and determining the quality of liquid s ubstances ready for consumption . 
Ordinance No  868 of 3  November  1998. (DOU.  DE 05/11/98). Available at 
http://www.anvisa.gov.br/legis/portarias/868_98.htm , Consulted on 21  July 2008.  
 
Article 2. This Decree shall enter into force six months after publication.  
Done b y the President of the Republic at San José, on the ___ day of the month of 
_________ in the year two thousand and nine. TO BE PUBLISHED.  
OSCAR ARIAS SÁNCHEZ  
 
 
      MARÍA LUISA ÁVILA AGÜERO  
      Minister  of Health