G/SPS/N/NIC/120  
30 June 2021 
(21-5227) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  
NOTIFICATION  
1. Notifying Member : NICARAGUA  
If applicable, name of local government involved:  
2. Agency responsible : Autoridad Nacional de Regulación Sanitaria , ANRS (National Health 
Regulat ory Authority)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO ; ICS numbers should be provided in addition, 
where applicable) : HS codes : 10, 11, 12, 15, 16, 17, 18, 19, 20, 21, 22, 24, 30, 
903010, 04, 09 ; ICS codes : 11.140, 67.020 , 67.040, 67.060, 67.100, 67.140, 67.160, 
67.180, 67.190, 67.200, 67.220, 67.230, 67.250, 67.260, 13.280, 65.160, 11.100.01, 
11.120.01, 11.120.10  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document : Ley No. 1068, Ley Creadora de la Autoridad Nacional 
de Regulación Sanitaria  (Law No. 1068, Law creating the National Health Regulatory 
Authority) Language(s) : Spanish Number of  pages : 4 
https://members.wto.org/crnattachments/2021/SPS/NIC/21_4406_00_s.pdf  
6. Description of content : The purpose of the notified Law is to create the Nat ional Health 
Regulatory Authority, as a public entity with legal personality, its own assets and technical 
and administrative autonomy . The National Health Regulatory Authority is attached to the 
Ministry of Health and has full capacity to acquire rights a nd contract obligations 
concerning matters within its competence, and will be the uninterrupted legal successor 
of the Directorate -General of Health Regulation, established by Decree No. 25-2006 
amending and supplementing Decree No. 71-98, Regulations implementing Law No. 290, 
Law on the Organization, Competence and Procedures of the Executive, published in La 
Gaceta , Official Journal Nos. 91 and 92 of 11 and 1 2 May 2 006. It currently operate s as 
the Directorate -General of Health Regulation in accordance with the institutional 
organizational chart . This entity will be known by the acronym ANRS and will be domiciled 
in the city of Managua.  
The purpose of the ANRS will be to facilitate, regulate, implement, develop and coordinate 
policies, laws, regulations and standards concerning health authorizations, surveillance, 
promotion, advertising, control and inspection of : medicines (breast milk and breast milk 
substitutes), vaccin es, biological and biotechnological products ; natural homeopathic and 
medicinal products ; food and beverages ; nutritional supplements ; medical devices and 
other health -related technology ; all products relating to ionizing radiation ; precursor 
chemicals ; cosmetic and hygiene products ; and tobacco and tobacco products . Its 
purpose will also be to : regulate and control donations, foreign medical brigades, medical 
and non -medical inputs ; and regulate professional health practices, audits on the quality 
of healt h-care services, establishments providing health services, pharmaceutical and 
non-pharmaceutical establishments, food establishments, and establishments providing G/SPS/N/NIC/120  
- 2 - 
  disinfection, structural or housing sanitation services using pesticides, toxic, hazardous 
and other similar substances ; and others that may have an impact on health.  
7. Objective and rationale : [X] food safety, [ ] animal health, [ ] plant protection , 
[X] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage f rom pests.  
8. Is there a relevant international standard ? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex 
standard or related text) : 
[ ] World Organisation for Animal Health (OIE) (e.g. T errestrial or Aquatic 
Animal Health Code, chapter number) : 
[ ] International Plant Protection Convention (e.g. I SPM No.) : 
[X] None  
Does this proposed regulation conform to the relevant international standar d? 
[ ] Yes [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and language(s) in which these are available:  
− Ley N°. 292, Ley de Medicamentos y Farmacias y su Reglamento con sus reformas.  
− Ley N°. 727, Ley para el Control del Tabaco y su Reglamento  
− Ley N°. 774, Ley de Medicina Natural, Terapias Complementarias y Productos 
Naturales en Nicaragua y su Reglamento  
− Ley N°. 156, Ley sobre Radiaciones Ionizantes  
− International instruments signed and ratified by Nicaragua, which are related to 
health control and regulation matters . Other laws, regulations and standards falling 
within its competence.  
10. Proposed date of adoption (dd/mm/yy) : 22 March 2 021 
Proposed d ate of publication (dd/mm/yy) : 24 March 2 021 
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/yy) : 24 March 2 021 
[X] Trade facilitating measure  
12. Final date for comments : [ ]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments : [X] National Notification 
Authority, [ ] National Enquiry Point . Address, fax number and email address (if 
available) of other body:  
13. Text(s) available from : [X] National Notification Authority, [ ] National Enquiry 
Point . Address, fax number and email address (if available) of other body:  
Ministerio de Fomento, Industria y Comercio (Ministry of Development , Industry and 
Trade)  
Km 6 Carretera a Masaya  
Managua, Nicaragua  
Tel.: (+505) 2248 9300, Ext. 1314 or 1310  
Email : notificacion@mific.gob.ni ; normalizacion@mific.gob.ni ; imartinez@mific.gob.ni  
 
Autoridad Nacional de Regulación Sanitaria (ANRS)  
Complejo Nacional de la Salud Dra, Concepción Palacios Costado Oeste de la Colonia 
Primero de Mayo  
Tel.: (+505) 2264 7730/2264 7630, Ext. 1290 ; 8930-1048 G/SPS/N/NIC/120  
- 3 - 
  Email : dgrs@minsa.gob.ni  
Website: http://www.minsa.gob.ni