The responsibility for marketing authorization of drugs and medicinal ingredients of the applicants/authorization holders in Vietnam
What are regulations on the responsibility for marketing authorization of drugs and medicinal ingredients of the applicants/authorization holders in Vietnam? What legal documents regulate this issue? Please get back to me.
The responsibility for marketing authorization of drugs and medicinal ingredients of the applicants/authorization holders in Vietnam (Image from the Internet)
The responsibility for marketing authorization of drugs and medicinal ingredients of the applicants/authorization holders is specified in Article 3 of Circular 32/2018/TT-BYT on marketing authorization of drugs and medicinal ingredients issued by the Minister of Health (effective from September 1, 2019). To be specific:
- Take responsibility for any revision to the label or package insert; comply with update request of the Ministry of Health (Drug Administration of Vietnam) during the effective period of the marketing authorization without having to submit an application for revision.
- Apply for revision according to Clause 4 Article 28 and Article 40 of this Circular during effective period of the marketing authorization.
- Ensure quality, safety and efficacy of the drugs/medicinal ingredients as declared in the application.
- Take responsibility for legitimacy and accuracy of every document in the application. Cooperate with the foreign authority and manufacturer in responding to inquiries of Drug administration of Vietnam regarding the authenticity of legal documents in the application.
- Send a written notice to Drug Administration of Vietnam within 30 days from the day on which the marketing authorization is revoked in any country if the drugs/medicinal ingredients have been granted the marketing authorization in Vietnam, and specify the reason for such revocation.
- At the request of a competent authority, cooperate with the manufacturer in ensuring that at least one of the two studies or provides additional information about the to-be-marketed drug when there is information or evidence about the safety and efficacy of the drug during the effective period of its market authorization.
- Cooperate with the manufacturer, importer and distributor in monitoring, collecting and analyzing information, and send a report to Drug Information and Adverse Reaction Center (DI&ADR) on post-vaccination reactions and adverse reaction of the drug in accordance with Clause 5 Article 77 of the Law on Pharmacy, guidelines for Good Pharmacovigilance Practices, national guidelines for pharmacovigilance and relevant regulations.
- Maintain the marketing authorization holder’s eligibility for operation during the effective period of the marketing authorization. In cases where the current authorization holder is no longer eligible for operation, it shall follow procedures for changing the authorization holder in accordance with Clause 4 Article 28 and Article 40 of this Circular within 30 days from the day on which the marketing authorization holder no longer qualifies for operation.
- Take responsibility for issues relevant to intellectual property rights of the drugs/medicinal ingredients registered in Vietnam.
- Cooperate with the manufacturer in updating specifications of drugs/medicinal ingredients in accordance with Circular No. 11/2018/TT-BYT and Circular No. 13/2018/TT-BYT.
- Implement the approved risk management plan in the application for issuance or renewal of the marketing authorization for vaccines.
- Take responsibility in accordance with Clause 2 Article 57 of the Law on Pharmacy and provisions of this Article for the proposed drugs/medicinal ingredients from the day on which Drug Administration of Vietnam signs the permission for changing the marketing authorization holder, including the drugs/medicinal ingredients approved for marketing authorization before such permission is signed.
- Assume other responsibility specified in this Circular and relevant regulations of law.
Above is the consulting content.
