G/TBT/N/PAN/113  
22 February  2021 
(21-1464) 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 : PANAMA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Ministerio de Salud  (Ministry of Health)  
Dirección Nacional de Farmacia y Drogas  (National Pharmacy and Drugs Directorate)  
Ministerio de Salud  (Ministry of Health)  
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:  
Calle Culebra, Ancón Antiguo Hospi tal Gorgas, detrás del Instituto Oncológico  
Panamá, Panama  
Tel.: 512-9163, Ext. 1084  
Email: uperez@minsa.gob.pa ; edcastillo@minsa.gob.pa  
Website : http://www.minsa.gob.pa  
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 (HS 30) ; Essential oils and resinoids ; perfumery, cosmetic or 
toilet preparations (HS 33) ; Insecticides, rodenticides, fungicides, herbicides, anti -
sprouting products and plant -growth regulators, disinfectants and simil ar products, put 
up in forms or packings for retail sale or as preparations or articles (for example, sulphur -
treated bands, wicks and candles, and fly -papers) (HS 3808)  
5. Title, number of pages and language(s) of the notified document : Borrador de 
Decre to Ejecutivo, Que reglamenta la Ley 1 de 10 de enero de 2001, Sobre Medicamentos 
y otros Productos para la Salud Humana  (Draft Executive Decree implementing Law No. 
1 of 1 0 January 2 001 on medicines and other human health products) (131 pages, in 
Spanish)  
6. Description of content : The notified Executive Decree sets out the implementing 
regulations for Law No. 1 of 1 0 January 2 001, which regulates all aspects relating to the 
functions of the National Pharmacy and Drugs Directorate ; the charging of fees for  the 
Directorate's services ; and all aspects relating to the registration of the following 
pharmaceutical products:  
• Topical antiseptics  
• Bactericides and disinfectants  
• Biological and biotechnological products  
• Cosmetics  G/TBT/N/PAN/113  
- 2 - 
  • Herbal medicines  
• Chemically synthesized medicines  
• Homeopathic medicines  
• Orphan medicines  
• Pesticides for household and public health use  
• Household and hospital cleaning products with antiseptic and fungicidal 
properties  
• Radiopharmaceuticals  
• Vitamin or dietary supplements  
It also sets out implementing regulations for all aspects relating to the accelerated 
registration procedure ; labelling ; stability ; interchangeability ; manufacture, control and 
inspection and other provisions ; marketing ; prior and post - verification of pharmaceuti cal 
products ; the National Pharmacovigilance System ; pharmacotherapy ; regulation and 
inspection of pharmaceutical establishments ; good manufacturing practices for cosmetic, 
antiseptic and disinfectant products and household pesticides ; registration require ments 
for raw materials, excipients and packaging inputs in industries producing medicines, 
cosmetics, disinfectants, pesticides and other products ; product distribution ; good 
pharmaceutical practices ; prescriptions ; and government procurement of human hea lth 
products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : In view of scientific and technological developments at the national and 
international level, and given the need to modify and update all legislation on medicines 
and other human health products, all legislation related to the regulations implementing 
Law No. 1 of 2001 "on medicines and other human health products" has been consolidated 
and updated in a single text so as to ensure the Law is properly implemented ; Other 
8. Relevant documents:  
• Ley 1 de 2001 Sobre Medicamentos y otros Productos para la Salud H umana  
• Borrador de Decreto Ejecutivo, Que reglamenta la Ley 1 de 10 de enero de 2001, 
Sobre Medicamentos y otros Productos para la Salud Humana  
9. Proposed date of adoption To be determined  
Proposed date of entry into force : To be determined  
10. Final date for comments : 60 days from notification  
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 Salud  (Ministry of Health)  
Dirección Nacional de Farmacia y Drogas  (National Pharmacy and Drugs Directorate)  
Calle Culebra, Ancón Antiguo Hospital Gorgas, detrás del Instituto Oncológico  
Panamá, Panama  
Tel.: 512-9163, Ext. 1084  
Email: uperez@minsa.gob.pa ; edcastillo@minsa.gob.pa  
Website : http://www.minsa.gob.pa  
https://members.wto.org/crnattachments/2021/TBT/PAN/21_1287_00_s.pdf