Chương I Nghị định 104/2016/NĐ-CP: Quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Decree provides for safety of vaccination and provision of vaccine injury compensation.

Article 2. Regulated entities

1. This Decree applies to health facility giving vaccinations that are part of expanded immunization programs and vaccinations against epidemics.

2. Provider of vaccination services shall satisfy vaccination safety requirements specified in this Decree, prepare reports and plans for ensure adequate supply of vaccines for their vaccination activities.

Article 3. Definitions

1. Vaccination means administration of a vaccine into the human body to develop adaptive immunity to a pathogen.

2. Vaccination against epidemic means free vaccination given by the State for people susceptible to an infectious disease in an epidemic zone and people sent by the State to the epidemic zone.

3. Cold chain equipment means a system of equipment for preserving, monitoring temperature and transport vaccines from the manufacturer to the vaccination clinics.

4. Adverse events following immunization are abnormal health phenomena that appear at the injection site or in the whole body after vaccination, not necessarily because of the administration of vaccines, comprising common vaccine side effects and serious vaccine injuries.

5. Serious vaccine injury means an adverse event following vaccination that threatens the vaccinee’s life or leaves sequelae or causes the death of the vaccinee.

6. A vaccination clinic means a health facility that has fulfilled all conditions for giving vaccinations and has submitted a declaration of eligibility for vaccination in accordance with this Decree.