G/TBT/N/PER/115  
13 September  2019 
(19-5880) 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 : PERU 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Salud, Dirección General de Medicamentos, Insumos y Drogas  - DIGEMID 
(Ministry of Health, Directorate -General of Drugs and Medicinal Products)  
Av. Parque de las Leyendas 240 Torre B - San Miguel  
Tel.: (+51-1) 631-4300 
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:  
Ministerio de Comercio Exterior y Turismo  - MINCETUR (Ministry  of Foreign Trade and 
Tourism)  
Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru 
Tel.: (+51-1) 513 -6100 Ext. 1223 and 1239  
Email : otc@mincetur.gob.pe  
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) : 
Pharmaceutical products ; Pharmaceutical products (HS 30)  
5. Title, number of pages and language(s) of the notified document : Technical 
guidelines : Guidelines for inspection of good manufacturing practices for pharmaceutical 
products (186 pages, in Spanish)  
6. Description of conte nt: The "Guidelines for inspection of good manufacturing practices 
for pharmaceutical products" are designed for checking compliance with good 
manufacturing practices for pharmaceutical products  
7. Objective and rationale, including the nature of urgent p roblems where 
applicable : Protection of human health or safety.  
8. Relevant documents:  
1. Ley N° 29459, Ley de los Productos Farmacéuticos, Dispositivos Médicos y 
Productos Sanitarios  (Law No. 29459, Law on pharmaceutical products, medical 
devices and sanitary products)  
2. Decreto Supremo N° 014 -2011/SA, Reglamento de Establecimientos 
Farmacéuticos  (Supreme Decree No. 014-2011/SA, Regulations on 
pharmaceutical establishments)  G/TBT/N/PER/115  
- 2 - 
  9. Proposed date of adoption : Not applicable  
Proposed date of entry into force : Not applicable  
10. Final date for comments : Not applicable  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio  de Comercio Exterior y Turismo  - MINCETUR (Ministry of Foreign Trade and 
Tourism)  
Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru 
Tel.: (+51-1) 513 -6100 Ext. 1223 and 1239  
Email : otc@mincetur.gob.pe  
Ministerio de Salud, Dirección General de Medicamentos, Insumos y Drogas  - DIGEMID 
(Ministry of Health, Directorate -General of Drugs and Medicinal Products)  
Av. Parque de las Leyendas 240 Torre B  - San Miguel  
Tel.: (+51-1) 631-4300 
https://www.gob.pe/institucion/minsa/normas -legales/291916 -779-2019-minsa  
http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2019/RM_779 -
2019-MINSA.pdf  
http://extranet.comunidadandina.org/ sirt/public/index.aspx  
http://www.mincetur.gob.pe/reglamentostecnicos  
https://members.wto.org/crnattachments/2019/TBT/PER/19_5028_00_s.pdf