G/TBT/N/NIC/169  
29 June 2021 
(21-5210) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : NICARAGUA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Autoridad Nacional de Regulación Sanitaria , ANRS (National Health Regulation 
Authority)  
Complejo Nacional de la Salud Dra, Concepción Palacios Costado Oeste de la Colonia 
Primero de mayo  
Tel.: (+505) 22647730 -22647630 Ext. 1290 ; 8930-1048 
Email: dgrs@minsa.gob.ni  
Website: www.minsa.gob.ni  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
3. Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other [X] : General 
legislation on health and safety  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : HS: 04, 
09, 10, 11, 12, 15, 16, 17, 18, 19, 20, 21, 22, 24, 30 ; ICS: 11.100.01, 11.120.01, 
11.120.10, 11.140, 13.280, 65.160, 67.020, 67.040, 6 7.060, 67.100, 67.140, 67.160, 
67.180, 67.190, 67.200, 67.220, 67.230, 67.250, 67.260  
5. Title, number of pages and language(s) of the notified document : Ley N°. 1068, 
Ley Creadora de la Autoridad Nacional de Regulación Sanitaria  (Law No. 1068, Law 
creating the National Health Regulatory Authority) (4 pages, in Spanish)  
6. Description of content : The purpose of the notified Law is to create the National Health 
Regulatory Authority, as a public entity with legal personality, its own assets and techni cal 
and administrative autonomy . The National Health Regulatory Authority is attached to the 
Ministry of Health and has full capacity to acquire rights and contract obligations 
concerning matters within its competence, and will be the uninterrupted legal s uccessor 
of the Directorate -General of Health Regulation, established by Decree No. 25-2006 
amending and supplementing Decree No. 71-98, Regulations to Law No. 290, Law on the 
Organization, Competence and Procedures of the Executive, published in Official Journal, 
La Gaceta , Nos 91 and 92 of 11 and 1 2 May 2 006, which currently operates 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), vaccines, biological and biotechnological products ; natural homeopathic and G/TBT/N/NIC/169  
- 2 - 
  medicinal products ; food and beverages ; nutritional supplements ; medical devices and 
other health -related technology ; all prod ucts 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 h ealth professional practices, audits on the quality 
of health care services, establishments providing health services, pharmaceutical and 
non-pharmaceutical establishments, food establishments, and establishments providing 
disinfection, structural or housi ng sanitation services using pesticides, toxic, hazardous 
and other similar substances ; and others that may have an impact on health.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health or safety  
8. Relevant documents:  
• 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 the Republic of Nicaragua, 
which are related to health control and regulation matters . Other laws, 
regulations and stand ards falling within its competence.  
9. Proposed date of adoption 22 March 2 021 
Proposed date of entry into force : 24 March 2 021 
10. Final date for comments : Not applicable  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Fomento, Industria y Comercio (Ministry of Development, Industry and 
Trade)  
Dirección de Normalización y Metrología (Directorate of Standardization and Metrology)  
Centro de Información Sobre obstáculos Técnicos al Comercio  (TBT Enquiry Point)  
Carretera a Masaya, Kilómetro 6, frente a Camino de Oriente . Managua, Nicaragua  
(+505) 2248 9300, Ext. 1314 or 1310  
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) 22647730 -22647630 Ext. 1290 ; 8930-1048 
Email: dgrs@minsa.gob.ni  
Website: www.minsa.gob.ni  
https://members.wto.org/crnattachments/2021/TBT/NIC/21_4349_00_s.pdf