. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/DOM/67 
2 September 2009 
 (09-4102) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   DOMINICAN REPUBLIC
 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:    
Dirección General de Normas y Sistemas de Calidad , DIGENOR  
(Directorate-General of Standards and Quality Systems) Edificio de Oficinas Gubernamentale s "Juan Pablo Duarte", piso 11 
Avenida México, esquina Leopoldo Navarro 
Santo Domingo, Dominican Republic 
Tel.: +1 809-686-2205 Fax: +1 809-688-3843 E-mail: direcciongeneral@gob.do
 
Website: http://www.digenor.gob.do  
Name and address (including telephone and fax numbers, E-mail 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 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.  
ICS numbers may be provided in addition, where applicable):   International 
Classification for Standards (ICS) code 11.120.10 
5. Title, number of pages and language(s) of the notified document:   NORDOM 11:1-022: 
Medicamentos. Principios de Buenas Prácticas de Manufactura de Productos 
Farmacéuticos  (Dominican Standard (NORDOM) No. 11:1-022: Medicine.  Principles of 
Good Manufacturing Practices (GMPs) for pharma ceutical products) (73 pages, in Spanish). 
6. Description of content:   Definitions;  Quality manageme nt;  Quality control; Sanitation 
and hygiene;  Validation;  Complaints;  Product withdrawal;  Organization and personnel; 
Quality audit;  Premises;  Equipment;  Documentation;  Good production practices;  Sterile 
products;  Active ingredient;  and Inspection. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
The notified Standard establishes the framewo rk for compliance with Good Manufacturing 
Practice (GMP) requirements. G/TBT/N/DOM/67 
Page 2  
 
  8. Relevant documents:  
Ministerio de Salud y Previsión Social, Direcci ón General de Servicios de Salud. Normas 
de Buenas Prácticas de Manufac tura de Productos Farmacéuticos  (Ministry of Health and 
Social Welfare, Directorate-General of Health Services. Good Manufacturing Practice 
(GMP) Standards for Pharmaceutical Products), Bolivia. 
Secretaría de Estado de Salud Pública y Asistenc ia Social. Normas de Buenas Prácticas de 
Manufactura Farmacéutica  (Ministry of Public Health and Social Welfare. Good 
Pharmaceutical Manufacturing Practice St andards), Second revised edition, 2000, 
Dominican Republic, Ley General de Salud (General Health Law) No. 42-01. 
9. Proposed date of adoption:   
Proposed date of entry into force:    21 November 2008 
21 May 2009   
10. Final date for comments:   -   
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers and E-mail and website addresses, if available, of other body:   
Dirección General de Normas y Sistemas de Calidad (DIGENOR) 
Edificio de Oficinas Gubernamentale s "Juan Pablo Duarte", piso 11 
Ave. México, esquina Leopoldo Navarro Santo Domingo, República Dominicana Tel.: +1 809 686-2205 Fax: +1 809 688-3843 E-mail: cendoc@digenor.gob.do
 
Website: http://www.digenor.gob.do