PER/94
WTO/TBT
PE Peru
  • 30 - Pharmaceutical products
2017-08-16
2017-05-30
Pharmaceutical products classified under Chapter 30 of the Harmonized System or Customs Tariff.
Proyecto de Reglamento que regula los estudios de estabilidad de las especialidades farmacéuticas (Draft Regulation governing stability studies for pharmaceutical specialties) (25 pages, in Spanish)

The purpose of the notified Regulation is to establish:

- the rules governing stability studies on pharmaceutical specialties; and

- the information to be included in the document required for the evaluation of stability studies when registering or re-registering pharmaceutical specialties or when making changes to the pharmaceutical specialties sanitary register.