Chapter VII
IMPLEMENTATION CLAUSES
Article 46. Effect
1. This Circular comes into force from September 01, 2019.
2. Circular No. 44/2014/TT-BYT dated November 25, 2014 of the Minister of Health on drug registration, except for regulations on regulations of in vitro diagnostic reagents, shall expire from the effective date of this Circular.
Article 47. Transition clauses
1. Applications submitted before the effective date of this Circular shall be processed in accordance with Circular No. 44/2014/TT-BYT, unless the applicant wishes to apply regulations on this Circular when it comes into force.
2. A marketing authorization that expires during the period from January 01, 2018 to June 30, 2020 will be extended for 12 more months if all of the following requirements are satisfied:
a) The applicant is not suspended from applying for issuance or renewal of the marketing authorization according to Clause 2 Article 100 of Decree No. 54/2017/ND-CP; Clause 54 Article 4 and Point a Clause 53 Article 5 of Decree No. 155/2018/ND-CP;
b) There is no warning against the safety or efficacy of the drug/medicinal ingredient issued by WHO or any drug regulatory authority of Vietnam;
c) The authorization holder submits an application for renewal of the marketing authorization (form No. 6/TT enclosed herewith);
Drug Administration of Vietnam shall send a written response within 20 days from the day on which the application is received.
3. If a new marketing authorization is granted during the effective period of the old marketing authorization, both of them can be simultaneously effective and the latter will be effective for 06 months from the effective date of the former.
4. Proprietary drugs that are recognized by Drug Administration of Vietnam before the effective date of this Circular are still recognized. Authorization holders shall update the categorization of their proprietary drugs in accordance with Appendix II hereof within the effective period of the marketing authorization.
Article 48. Implementation roadmap
1. The duration of marketing authorization for excipients and capsule shells shall comply with Clause 8 Article 143 of Decree No. 54/2017/ND-CP.
2. The duration of marketing authorization for semi-finished herbal ingredients shall comply with Point c Clause 78 Article 5 of Decree No. 155/2018/ND-CP.
3. Regarding applications for renewal or revision of the marketing authorization submitted before January 01, 2020: specifications of the drug product, active ingredients, herbal ingredients, name and address of manufacturers thereof are not requirements in the CPP.
4. The legal documents specified in Clause 11 Article 24 of this Circular are not required for applications for marketing authorization for semi-finished herbal ingredients, semi-finished medicinal ingredients that are herbal ingredients, excipients, capsule shells and ingredients thereof that are submitted before January 01, 2021.
Article 49. Reference clauses
In cases where a legislative document or regulation referred to in this Circular is amended or replaced, the newest one shall apply.
Article 50. Responsibility for implementation
1. Drug Administration of Vietnam, pursuant to the roadmap for ASEAN harmonization of drug registration, has the responsibility to:
a) Organize the implementation of this Circular;
b) Update on its website the list of drugs and medicinal ingredients whose marketing authorizations are granted or renewed within 05 days from the day on which they are granted or renewed, other information about registration of drugs and medicinal ingredients;
c) Update on its website the list of drugs with demonstrated bioequivalence within 05 days from the day on which their marketing authorization is granted, revisions to information about these drugs within 07 days from the day on which the revisions are approved;
d) Update on its website the list of proprietary drugs within 05 days from the day on which their marketing authorization is granted, revisions to information about these proprietary drugs within 07 days from the day on which the revisions are approved;
dd) Review the recognized proprietary drugs after they may no longer satisfy the criteria;
e) Develop, issue and organize implementation of SOPs in drug registration and QM;
g) Cooperate with Traditional Medicine Administration of Vietnam in renewing and revising the marketing authorizations of traditional drugs and herbal drugs that were issued under Circular No. 44/2014/TT-BYT;
h) In the cases where an applicant forges or falsifies legal documents of Vietnamese or foreign authorities, uses a fraudulent seal or signature of an organization in the application, Drug Administration of Vietnam will issue a warning and stop receiving applications from such applicant in accordance with Clause 2 through 4 Article 100 of Decree No. 54/2017/ND-CP.
Other than Drug Administration of Vietnam will make an announcement about the violation on its website, inform inspection authorities and competent authorities for handling as prescribed by law;
i) Where necessary, Drug Administration of Vietnam shall hold a meeting with the applicant, manufacturer or experts to clarify the issues that arise during verification of the application;
k) Publish on its website the list of authorization holders and manufacturers of drugs and medicinal ingredients in accordance with Clause 11 and Clause 15 Article 23 of this Circular.
l) Propose to the Minister of Health regulations and a roadmap for use of bar codes, QR codes and DataMatrix codes on secondary packages of drugs and medicinal ingredients marketed in Vietnam;
m) Return the label and package insert to the authorization holder within 30 days from the date of issue or renewal of the marketing authorization;
n) Publish on its website the origins of medicinal ingredients of domestically manufactured drugs of proprietary drugs within 15 days from the date of issue or renewal of the marketing authorization; within 07 days from the day on which the revisions to the marketing authorization are approved.
2. Departments of Health of provinces shall carry out inspection of the implementation of this Circular by pharmaceutical manufacturers and sellers in their provinces.
3. Affiliated units of the Ministry of Health, Vinapharm and drug sellers have the responsibility for implementation of this Circular.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.
Tìm kiếm
Thông tư 32/2018/TT-BYT (Bản Pdf)
Thông tư 32/2018/TT-BYT (Bản Word)