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Description
of content: 1. This draft Circular
specifies:
a)
Documentation requirements, procedures for the issuance, renewal, revision
and revocation of marketing authorization for modern medicines, vaccines,
biologicals, herbal drugs and medicinal materials (including active
ingredients, semi-finished herbal ingredients, excipients, and capsule
shells) for human use in Vietnam;
b) Required
clinical data to ensure safety and efficacy in the application;
c)
Requirements for exemption from clinical trial or certain phases thereof in
Vietnam; drugs to be subjected to Stage 4 clinical trial;
d) Rules for
the validation of marketing authorization applications (hereinafter referred
to as "marketing application") for drugs/medicinal materials, their
renewal and revision;
dd) Rules for
the validation of applications for license to import drugs that are yet to be
approved for
marketing authorization (hereinafter referred to as "unapproved
drugs") in the cases specified in Point a Clause 43 Article 5 of Decree
No. 155/2018/ND-CP dated November 12, 2018 providing amendments to
regulations on business conditions under state management of the Ministry of
Health of Vietnam (hereinafter referred to as
"Decree
No. 155/2018/ND-CP");
e) Organizing
and operating principles of the Advisory Council for issuance of marketing
authorization of drugs and pharmaceutical ingredients (hereinafter referred
to as the Council);
g) Procedures
for the assessment of applications for the granting, extension, variation of
marketing authorizations for finished medical products and medicinal
ingredients; procedures for the assessment of applications for import
licenses of drugs without marketing authorization.
h) Dossier
and procedures for granting certificates of circulation of drugs in the form
of reference and recognition;
i)
Regulations on drugs that must undergo bioequivalence testing and
requirements for dossiers reporting bioequivalence research data in drug
circulation registration in Vietnam.
2. This draft
Circular does not apply to the cases specified in Point a, b, Clause 2,
Article 54 of the Law on Pharmacy, excipients, capsule shells, and
semi-finished medicinal products for the manufacture of drugs according to
drug registration dossiers that have a Certificate of Drug Circulation
Registration in Vietnam; capsule shells, excipients used for testing,
research or manufacturing of exported drugs and semi-finished medicinal
products produced by the manufacturing facility itself for the manufacture of
finished drugs, except in cases where the registration facility voluntarily
request it.
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