About Intellectual Property IP Training Respect for IP IP Outreach IP for… IP and... IP in... Patent & Technology Information Trademark Information Industrial Design Information Geographical Indication Information Plant Variety Information (UPOV) IP Laws, Treaties & Judgments IP Resources IP Reports Patent Protection Trademark Protection Industrial Design Protection Geographical Indication Protection Plant Variety Protection (UPOV) IP Dispute Resolution IP Office Business Solutions Paying for IP Services Negotiation & Decision-Making Development Cooperation Innovation Support Public-Private Partnerships AI Tools & Services The Organization Working with WIPO Accountability Patents Trademarks Industrial Designs Geographical Indications Copyright Trade Secrets WIPO Academy Workshops & Seminars IP Enforcement WIPO ALERT Raising Awareness World IP Day WIPO Magazine Case Studies & Success Stories IP News WIPO Awards Business Universities Indigenous Peoples Judiciaries Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions Economics Finance Intangible Assets Gender Equality Global Health Climate Change Competition Policy Sustainable Development Goals Frontier Technologies Mobile Applications Sports Tourism PATENTSCOPE Patent Analytics International Patent Classification ARDI – Research for Innovation ASPI – Specialized Patent Information Global Brand Database Madrid Monitor Article 6ter Express Database Nice Classification Vienna Classification Global Design Database International Designs Bulletin Hague Express Database Locarno Classification Lisbon Express Database Global Brand Database for GIs PLUTO Plant Variety Database GENIE Database WIPO-Administered Treaties WIPO Lex - IP Laws, Treaties & Judgments WIPO Standards IP Statistics WIPO Pearl (Terminology) WIPO Publications Country IP Profiles WIPO Knowledge Center WIPO Technology Trends Global Innovation Index World Intellectual Property Report PCT – The International Patent System ePCT Budapest – The International Microorganism Deposit System Madrid – The International Trademark System eMadrid Article 6ter (armorial bearings, flags, state emblems) Hague – The International Design System eHague Lisbon – The International System of Appellations of Origin and Geographical Indications eLisbon UPOV PRISMA UPOV e-PVP Administration UPOV e-PVP DUS Exchange Mediation Arbitration Expert Determination Domain Name Disputes Centralized Access to Search and Examination (CASE) Digital Access Service (DAS) WIPO Pay Current Account at WIPO WIPO Assemblies Standing Committees Calendar of Meetings WIPO Webcast WIPO Official Documents Development Agenda Technical Assistance IP Training Institutions COVID-19 Support National IP Strategies Policy & Legislative Advice Cooperation Hub Technology and Innovation Support Centers (TISC) Technology Transfer Inventor Assistance Program WIPO GREEN WIPO's Pat-INFORMED Accessible Books Consortium WIPO for Creators WIPO Translate Speech-to-Text Classification Assistant Member States Observers Director General Activities by Unit External Offices Job Vacancies Procurement Results & Budget Financial Reporting Oversight

Main text(s) Main text(s) Spanish Decreto N° 3 que aprueba Reglamento del Sistema Nacional de Control de los Productos Farmacéuticos de Uso Humano (modificado al 21 de agosto de 2020)     

 

Download PDF open_in_new

 

Download PDF open_in_new

 

Download PDF open_in_new

 

Download PDF open_in_new

Additional Text(s) WTO Notifications Coversheet (3 text(s)) WTO Notifications Coversheet (3 text(s)) French Décret n° 3 portant approbation du règlement sur le système national de contrôle des produits pharmaceutiques à usage humain (modifié jusqu'au 21 août 2020) Spanish Decreto N° 3 que aprueba Reglamento del Sistema Nacional de Control de los Productos Farmacéuticos de Uso Humano (modificado al 21 de agosto de 2020) English Decree No. 3 Approving the Regulations for the National Control System for Pharmaceuticals for Human Use (amended up to August 21, 2020)

 

Download PDF open_in_new

 

Download PDF open_in_new

 

Download PDF open_in_new

 

Download PDF open_in_new

Legislation Implements (1 text(s)) Implements (1 text(s))

• Health Code (promulgated by Decree-Law No. 725, and amended up to Law No. 21030) (CL108)

Supersedes (2 text(s)) Supersedes (2 text(s))

• Decree No. 3 Approving the Regulation of the National System of Control of Pharmaceutical Products for Human Use (as amended up to Decree No. 85 of October 30, 2015)  (CL081)
• Decree No. 3 on Approval of the Regulation of the National System of Control of Pharmaceutical Products for Human Use (CL076)

Is implemented by (1 text(s)) Is implemented by (1 text(s))

• Exemption Decree No. 945 Approving Technical Standard No. 170 on Registration of Biotechnology Products derived from Recombinant DNA Techniques (as amended by Exemption Decree No. 50) (CL113)

Historical Versions Repeals (1 text(s)) Repeals (1 text(s))

• Decree No. 1.876 Approving Regulations for the National System for Control of Pharmaceutical Products, Food for Medical Use and Cosmetics (CL035)

WTO Document Reference

IP/N/1/CHL/19

IP/N/1/CHL/U/3