Circular 16/2023/TT-BYT regulating registration for processed drugs and technology transferred drugs in Vietnam

On August 15, 2023, the Minister of Health issued Circular 16/2023/TT-BYT (‘Circular 16’) replacing Circular 23/2013/TT-BYT regulating storage registration. regulations for processed drugs and technology transferred drugs in Vietnam. This Circular provides general regulations on registration for circulation of processed drugs and technology-transferred drugs produced in Vietnam; Documents and procedures for the issuance, extension, change, supplementation, and revocation of registration papers for circulation registration for processed drugs and technology transferred drugs in Vietnam (pharmaceutical drugs, vaccines, biological products, herbal drugs).

Basic information of Circular 16/2023/TT-BYT regulating registration for processed drugs and technology transferred drugs in Vietnam

Symbol number: 16/2023/ND-CP

Date of issue: August 15, 2023

Effective date: October 1, 2023

Document type: Circular

Issuing agency: Minister of Health

Signed by: Do Xuan Tuyen

New points of Circular 16/2023/TT-BYT regulating registration for processed drugs and technology transferred drugs in Vietnam

Register for circulation of processed drugs

The Circular clearly stipulates the registration for circulation of processed drugs. Accordingly, processed drugs when registered for circulation are classified as follows:

• Processed drugs have the same contents as ordered drugs, including drug preparation formula; production process; raw material quality standards; finished drug quality standards; and tradenames.

In case the drug ordered for processing is a drug that has been announced by the Ministry of Health as the original brand name, the reference biological product, and the processed drug have changed compared to the drug ordered for processing in at least one of the criteria at this point (excluding including change of trade name) or other changes related to drug quality, these changes must be approved by the pharmaceutical management agency of the manufacturing country or the management agency specified in Clause 9, Article 2 of the Circular 08/2022/TT-BYT has licensed the circulation of that drug or the registration facility must provide data proving that the processed drug is equivalent in quality to the processed drug.

• Other processed drugs do not fall into the cases specified above.

The Circular also states: For processed drugs, there is a roadmap for processing production stages in Vietnam, annually from the date of issuance of the circulation registration certificate, the facility registering the processed drug or the facility The recipient of drug processing specified above must report the progress of processing stages of the finished drug manufacturing process in Vietnam to the Ministry of Health (Drug Administration) according to Form 04/TT Appendix 1 was issued together with this Circular.

The validity of the registration certificate for circulation of processed drugs is implemented according to the provisions of Clause 1 and Clause 2, Article 8 of Circular 08/2022/TT-BYT.

The time to apply for an extension of registration for circulation of processed drugs shall comply with the provisions in Clause 4, Article 8 of Circular 08/2022/TT-BYT.

Application for registration of processed drugs and technology transfer drugs

Processing and technology transfer registration dossiers must ensure compliance with the following regulations:

• Language used in the registration dossier: The registration dossier for processed drugs or technology transfer drugs must be written in Vietnamese or English. The drug instructions for use and summary of product characteristics must be written in Vietnamese.
• Registration dossiers for processed drugs and technology transfer drugs are made according to the form issued with Circular 16/2023/TT-BYT: Cover page (Form 01/TT – Appendix 1) and arranged according to the correct procedure. Order of table of contents (Form 05/TT – Appendix 1). The following documents must be bound into separate sections and accompanied by 1 application of Bioequivalence research documents and Preclinical and clinical documents.
• The registration dossier must have the confirmation stamp of the registration facility drug processing facility or drug manufacturing technology transfer facility (drug manufacturing facility) on the first page of each section in the entire dossier (accept the seal of the Representative Office for foreign registered establishments)
• For documents provided by a drug processing facility or a drug production technology transfer facility, the document must have the confirmation stamp of this facility. In case the facility ordering drug processing or the facility transferring drug manufacturing technology does not use the seal according to the regulations of the host country, the facility registering the processed drug or the facility registering the technology transfer drug must affix the seal to confirm on these documents, commit that the host country of the drug processing facility or drug production technology transfer facility does not use seals and is responsible for the truthfulness of the above documents.
• Drugs can be registered in the same dossier when they have the following elements in common: drug name; dosage forms; route of administration; drug quality standards; name and address of the manufacturer, facility receiving drug processing, or facility receiving drug production technology transfer); same preparation formula, in which:
• Solid drugs with divided doses: have the same content, calculated according to divided dose units;
• Undivided solid, liquid, or semi-solid drugs with the same concentration or drug content; Injectable or infusion drugs with the same concentration or content of pharmaceutical ingredients and packaging materials in direct contact with the drug.
• Regulations on documents in dossiers requesting issuance, extension, change, and supplementation of circulation registration certificates for processed drugs and technology transferred drugs comply with the provisions of Article 22 of Circular 08/2022/TT -BYT;
• Regulations on the application of online documents: The application of online documents is implemented according to the provisions of Clause 6, Article 6 of Circular 08/2022/TT-BYT.

The number of documents that must be submitted in the application dossier for granting or renewing a circulation registration certificate is as follows:

• (01) ministry has complete documents as prescribed in Article 12 of Circular 16/2023/TT-BYT
• In addition to the above documents, an additional 01 (one) copy of complete documents for vaccines and biological products and 02 (two) copies of documents including registration application, quality standards and testing methods are required. for the remaining cases;
• 02 (two) sets of drug label samples and instructions for use of the drug expected to be circulated with the confirmation stamp of the registration facility (representative office’s seal is accepted for foreign registration facilities) or the registration facility production (not applicable to applications for extension of circulation registration). Medicine labels are mounted and designed on A4 paper size. In case of online application, the facility only submits 01 set of drug label samples and drug use instructions.

Number of documents to be submitted in the application for registration of changes or additions to the circulation registration certificate:

• 01 (one) set with all documents as prescribed in Article 15 of Circular 16/2023/TT-BYT;
• 02 (two) sets of drug label samples and drug instructions for use requested to change in case of changing the label or instructions for use, with confirmation stamp of the registration facility (representative office’s seal is acceptable). for foreign registered establishments) or manufacturing establishments. Medicine labels are mounted and designed on A4 paper size. In case of online application, the facility only submits 01 set of drug label samples and drug use instructions.

Note: Verification of the authenticity of legal documents in the registration dossier of processed drugs, subject to technology transfer, is carried out by the provisions of Article 12 of Circular 08/2022/TT-BYT.

Drug processing contract

In addition to meeting the contents specified in Article 39 of Decree No. 69/2018/ND-CP, Circular 16 stipulates that drug processing contracts must have the following content:

• Agreement on the supply of materials. Providing technical documents from the facility ordering drug processing to the facility receiving the drug processing includes production process, quality standards, testing methods for starting materials, semi-finished products, finished products, accessory materials, and other documents related to drug production/processing.
• Rights and responsibilities of the facility ordering drug processing, the facility receiving drug processing, and the drug registration facility (if any):
• In each stage of the drug manufacturing process, in terms of production process, quality inspection, storage, and transportation of starting materials. semi-finished products, finished products, auxiliary materials, packaging, printing or labeling processes of processed drugs and regulations on the responsibilities of the facility that signs the testing slip for each batch of finished products and the release note of processed drugs;
• Regarding keeping records of production, quality inspection, distribution, circulation of drugs, storage of drug samples, and resolution of quality-related issues, complaints, and product recalls on the market.
• Responsibilities of the facility ordering the processing, the facility receiving the processing, and the drug registration facility (if any) for intellectual property issues related to processed drugs.
• Procedures for inspection and supervision of production facilities.
• The roadmap for processing stages of the processed drug production process in Vietnam and the responsibilities of relevant parties for processed drugs are specified in Clause 2, Article 6 of Circular 16.
• Cases of cancellation of agreement and liability for breach of agreement.

For all demands to advice on circulation registration for processed drugs and technology transfer drugs in Vietnam, please contact Viet An Law Firm for the best support.