Công văn 2396/QLD-ĐK năm 2019 yêu cầu về xuất xứ công thức đối với thuốc generic do Cục Quản lý dược ban hành

To: Applicants for Vietnam’s marketing authorization and manufacturers of drugs granted Vietnam’s marketing authorization,

Based on the conclusion of the advisory council on marketing authorization - Ministry of Health and for safe and efficient use of drugs

Drug Administration of Vietnam would like to notify you of the following requirements for origin of generic drug formulations:

1. For prescription drugs: the to-be-marketed drug shall contain the same components and active ingredient content as a drug that is included in medical documents or granted the marketing authorization by one of Vietnam’s reference authorities (European Medicines Agency (EMA) or the regulatory authority of the United States, Japan, France, Germany, Sweden, the United Kingdom, Switzerland, Australia, Canada, Belgium, Austria, Ireland, Denmark or the Netherlands) or granted the marketing authorization by at least 02 countries considered as Stringent Regulatory Authorities (SRA) by the World Health Organization (WHO), namely:

a) Members of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) prior to October 23, 2015: the U.S. Food and Drug Administration (US-FDA), regulatory authorities of the European Commission, Medicines and Healthcare Products Regulatory Agency of the United Kingdom (MHRA) and Pharmaceuticals and Medical Devices Agency of Japan (PMDA);

b) Observers of ICH prior to October 23, 2015: pharmaceutical regulatory authorities affiliated to the European Free Trade Association (ELTA), represented by Swiss Medic of Switzerland and Health Canada;

c) Associates through mutual recognition agreements with ICH members prior to October 23, 2015: Australia, Iceland, Liechtenstein and Norway.

2. For over-the-counter drugs: the to-be-marketed drug shall contain the same components and active ingredient content as a drug that is included in medical documents or granted the marketing authorization by at least 01 SRA country or granted the marketing authorization by at least 03 countries (including Vietnam) or manufactured in Vietnam and freely circulated for more than 10 years without any reported serious side effect, risk to vulnerable groups (e.g. children, the elderly, pregnant women) or scientific flaw in the formulation.

3. Applicants for the marketing authorization must present proof and take responsibility for information on drugs granted the marketing authorization by their countries of origin.

For your reference and compliance./.

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