Chapter IV
IMPLEMENTATION
Article 36. Effect
1. This Circular comes into force from June 01, 2018.
2. The Circular No. 06/2016/TT-BYT dated March 08, 2016 of the Minister of Health on drug labeling is annulled from the effective date of this Circular, except for regulations on labeling of in vitro diagnostic reagents, which shall remain effective until superseding documents are promulgated.
Article 37. Transition
1. With regard to drugs or medicinal ingredients granted registration numbers or import licenses before this Circular comes into force:
a) They may be sold with the labels and package inserts approved by the Ministry of Health until the expiry dates of batches of drugs or medicinal ingredients manufactured or imported within the validity of the registration certificates or the import licenses granted before this Circular comes into force, except for the case prescribed in Point b Clause 1 of this Article.
b) With regard to drugs and medicinal ingredients on the List of toxic drugs and toxic medicinal ingredients enclosed with the Circular No. 06/2017/TT-BYT dated May 03, 2017 of the Minister of Health on promulgation of the List of toxic drugs and toxic medicinal ingredients; drugs which are on the List of OTC drugs enclosed with the Circular No. 23/2014/TT-BYT dated June 30, 2014 of the Minister of Health on promulgation of the List of OTC drugs but not on the List of OTC drugs enclosed with the Circular No. 07/2017/TT-BYT dated May 03, 2017 of the Minister of Health on promulgation of the List of OTC drugs (hereinafter referred to as the “Circular No. 07/2017/TT-BYT”), registrants or importers must classify, update and supplement relevant information as follows:
- Drugs or medicinal ingredients manufactured before this Circular comes into force: comply with regulations in Point a Clause 1 of this Article;
- Drugs or medicinal ingredients manufactured from the date of entry into force of this Circular: Update information concerning the classification of drugs or medicinal ingredients on labels and package inserts in accordance with regulations in this Circular before selling drugs or medicinal ingredients on the market within 12 months as from the date of entry into force of this Circular without giving any notification to the Ministry of Health, unless an application is submitted for modification of the certificate of registration related to the package insert of drugs granted registration number as regulated in the Ministry of Health’s Circular on registration of drugs and medicinal ingredients.
2. Applications for certificate of free sale or permission for import of drug without registration numbers submitted to units affiliated to the Ministry of Health and have not been granted before the effective date of this Circular, excluding drugs and medicinal ingredients mentioned in Clause 3 of this Article, shall be considered as follows:
a) The registrant or importer may submit additional documents about the label and package insert of the drug in accordance with this Circular in order to be considered and granted the registration number or license for import of drugs without registration number;
b) If no additional documents are submitted as prescribed in Point a of this Clause, the label and package insert may be considered under Circular No. 06/2016/TT-BYT, excluding the case prescribed in Point b Clause 1 of this Article;
Within 06 months from the day on which the certificate of free sale is issued, the facility responsible for drug labeling shall update the label and package inserts in accordance with this Circular in the form of registration of changes according to the Ministry of Health’s Circular on registration of drugs and medicinal ingredients, excluding the case prescribed in Point b Clause 3 Article 6 of the Circular No. 07/2017/TT-BYT.
3. With regard to applications for registration of drugs or medicinal ingredients in the form of registration of changes of certificate of free sale with regard to changes in label and package insert, which have been submitted to units affiliated to the Ministry of Health and have not been granted, the registrant or importer must supplement samples of label and package insert in accordance with regulations of this Circular before this Circular comes into force.
Article 38. Announcing information on package inserts
1. The Drug Administration of Vietnam shall review, update and announce information on package inserts of drugs, which are on the List of proprietary drugs and reference biologics announced by the Ministry of Health and have been granted registration numbers, on its website so that manufacturers and registrants may refer to when preparing applications for registration of generic drugs or biosimilars.
2. Any information added to package inserts of drugs on the proprietary drugs and reference biologics during the sale of drugs must be announced and published on the website of the Drug Administration of Vietnam within 45 days from the date on which such additional information is given approval.
3. Registrants and manufacturers shall update and supplement information on package inserts of generic drugs or biosimilars in conformity with corresponding guidelines on use of drugs on the List of proprietary drugs and reference biologics published on the website of Drug Administration of Vietnam as follows:
a) Package inserts of generic drugs or biosimilars must be conformable with package inserts of drugs on the List of proprietary drugs and reference biologics in terms of concentrations, contents, active ingredients, dosage form, and administration routes, excluding information about expiry dates, composition, quality standard, bioavailability, pharmacokinetics, adverse effects and clinical test results. The package insert of generic drugs or biosimilars must have more adverse effects than those of corresponding proprietary drugs and reference biologics, except adverse effects of proprietary drugs or reference biologics related to excipients which are not contained in such generic drugs or biosimilars;
b) Within 12 months from the date on which Drug Administration of Vietnam announced and published package inserts of proprietary drugs and reference biologics on its website as regulated in Clause 1, Clause 2 of this Article, registrants and manufacturers of generic drugs and biosimilars must update information on labels and package inserts of their products in conformity with package inserts of proprietary drugs and reference biologics in terms of the information mentioned in Clause 2 of this Article without giving notification to the Ministry of Health, unless otherwise requested by the Ministry of Health.
Article 39. Terms of reference
In case the legislative documents and regulations cited in this Circular are changed or replaced, the newer ones shall apply.
Article 40. Responsibility for implementation
The Drug Administration of Vietnam, the Traditional Medicine Administration and units affiliated to the Ministry of Health, Departments of Health of provinces or central-affiliated cities, Vinapharm, Vietnamese and foreign drug registrants and drug manufacturers, importers, exporters of drugs and medicinal ingredients, health facilities and facilities preparing drugs according to prescriptions are responsible for the implementation of this Circular.
Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via the Drug Administration of Vietnam or the Traditional Medicine Administration) for consideration./.
Tìm kiếm
Thông tư 01/2018/TT-BYT (Bản Pdf)
Thông tư 01/2018/TT-BYT (Bản Word)