G/TBT/N/CHL/481  
27 June 2019 
(19-4331) 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 : CHILE 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible : 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:  
Dirección General de Relaciones Económicas Internacionales  - Ministerio de Relaciones 
Exteriores  (Directorate -General of International Economic Relations, Ministry of Foreign 
Affairs)  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 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  
5. Title, number of pages and language(s) of the notified document : "Guías Técnica 
asociadas a la Equivalencia Terapéutica" o Incorpora un apéndice a su anexo Nº 1 : Guía 
Técnica G -BIOF 01: L ineamientos para la demostración de equivalencia terapéutica de 
otras formas  farmacéuticas de administración oral con acción sistémica . Se agregan los 
siguientes anexos : o ANEXO Nº 6 : Guía Técnica G -BIOF 03: L ineamientos para la 
demostración de equivalencia terapéutica de formas farmacéuticas de administración oral 
con acción loca l en el tracto gastrointestinal. o ANEXO Nº 7 : Guía Técnica G -BIOF 04: 
Lineamientos para la realización de estudios para demostrar equivalencia terapéutica en 
formas de administración tópica. o ANEXO Nº 8 : Guía Técnica G -BIOF 05: L ineamientos 
para la realización de estudios para la demostración de equivalencia terapéutica en 
sistemas terapéuticos y parches de acción local. o ANEXO Nº 9 : Guía Técnica G -BIOF 06: 
Lineamientos para la realización de estudios para la demostración de equi valencia 
terapéutica en medicamentos administrados por vía inhalatoria. o ANEXO Nº 10 : Guía 
Técnica G -BIOF 07: L ineamientos para la realización de estudios para la demostración de 
equivalencia terapéutica en medicamentos complejos no biológicos que son for mulados 
como soluciones acuosas para ser administrados por vía parenteral  ("Technical guides on 
therapeutic equivalence", with an appendix added to Annex No. 1 (Technical Guide 
G-BIOF 01: G uidelines for demonstrating therapeutic equivalence of other oral d osage 
forms with systemic action) and the following annexes included : Annex No. 6 (Technical 
Guide G -BIOF 03: G uidelines for demonstrating therapeutic equivalence of oral dosage 
forms acting locally in the gastrointestinal tract), Annex No. 7 (Technical Gu ide G -BIOF 
04: G uidelines for conducting therapeutic equivalence studies for topical dosage forms), 
Annex No. 8 (Technical Guide G -BIOF 05: G uidelines for conducting therapeutic 
equivalence studies for therapeutic systems and locally acting patches), Annex  No. 9 
(Technical Guide G -BIOF 06: G uidelines for conducting therapeutic equivalence studies 
for inhaled medicines), and Annex No. 10 (Technical Guide G -BIOF 07: G uidelines for 
conducting therapeutic equivalence studies for non -biological complex drugs pre pared as 
aqueous solutions for parenteral administration)). (5 pages, in Spanish ; 10 pages, in 
Spanish ; 78 pages, in Spanish ; 18 pages, in Spanish ; 34 pages, in Spanish ; 12 pages, in 
Spanish)  G/TBT/N/CHL/481  
- 2 - 
  6. Description of content : Technical guides on the demonstrati on of  therapeutic 
equivalence of pharmaceutical products  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of health ; Ensuring the quality, safety and efficacy of medicines ; 
Protection of human health or safe ty; Quality requirements  
8. Relevant documents:  
Hyperlinks (place your cursor over the text, press Ctrl and click)  
Appendix 1 - G-BIOF 01: other oral dosage forms with systemic action  
Guide G BIOF 03 - Annex No. 6  
Guide G BIOF 04 - Annex No. 7  
Guide G BIOF 05 - Annex No. 8  
Guide G BIOF 06 - Annex No. 9  
Guide G BIOF 07 - Annex No. 10  
9. Proposed date of adoption : 6 months from enactment  
Proposed date of entry into force : 6 months from enactment  
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:  
Departamento Regulatorio  (Regulations Department)  
Dirección General de Relaciones Económicas Internacionales  (Directorate -General of 
International Economic Relations)  
Ministerio de Relaciones Exteriores  (Ministry of Foreign Affairs)  
Teatinos 180, piso 11  
Tel.: (+56) 2 -2827 5250  
Fax: (+56) 2 -2380 9494  
Email: Tbt_Chile@direcon.gob.cl  
Texts available at:  
https://www.minsal.cl/consultas -publicas -vigentes/  
https://members.wto.org/crnattachments/2019/TBT/CHL/19_3616_00_s.pdf  
https://members.wto.org/crnattachments/2019/TBT/CHL/19_3616_01_s.pdf  
https://members.wto.org/crnattachments/2019/TBT/CHL/19_3616_02_s.pdf  
https://members.wto.org/crnattachments/2019/TBT/CHL/19_3616_03_s.pdf  
https://members.wto.org/crnattachments/2019/TBT/CH L/19_3616_04_s.pdf  
https://members.wto.org/crnattachments/2019/TBT/CHL/19_3616_05_s.pdf