What is drugs registration? The work consists of the research and development of drugs, the registration of licenses for circulation in the market, monitoring in the process of circulation, changes in the circulation during the course to ensure the safety and effectiveness of as well as compliance with the laws and regulations in each country.
BizHub Consulting CO., LTD is a professional company in the field of consulting and registration dossiers for domestic and foreign enterprises. BizHub would like to introduce to you the necessary information as follows:
In order to facilitate and speed up the process of appraisal of drug registration dossiers, enterprises shall prepare drug registration dossiers divided into sections for submission at DAV as follows:
1. Dossiers for first registration, extension registration and supplementary dossiers shall be separated into separate sections, each of which shall be enclosed in one or several documents in the following order:
- Legal documents and quality documents as stipulated in Circular 44/2014/TT-BYT.
- Pre-clinical documents/ clinical documents as stipulated in Circular 44/2014/TT-BYT (apply to drugs are submited pre-clinical documents/ clinical documents)
- Bio-availability and bio-equivalence documents as stipulated in Circular 08/2010/TT-BYT (for drugs that must submit reports on data on bio-availability and bio-equivalence)
- The dossier proposing the evaluation of medicine-producing or -immediting establishments according to the provisions of Decree No. 54/2017/ND-CP (for cases where establishments manufacturing drugs / raw materials for drug production must be evaluated).
2. The application for drug registration must be produced on A4 paper and securely bound, enclosed with 01 product summary sheet in accordance with Form 04 / TT - Circular 44 and the table of contents.
The application must be arranged in the order of its contents and separated between different parts. Separated parts must be numbered for easy reference; each part is certified by the applicant or the drug manufacturer on its first page.
3. For Bio-availability and bio-equivalence documents shall submit one copy of the written instructions enclosed with seal, which is overlapped by the drug-registering establishment.
4. For pre-clinical documents/ clinical documents shall submit paper file and data file:
4.1.Data file: All pre-clinical documents/ clinical research according to Circular 44/2014/TT-BYT, save PDF. It can be researchable and can be written to a USB stick in a sturdy package with a label that records information about the file code, file type, drug name, company name.
4.2 Paper file:
- One copy of the written instructions, the summary of drug characteristics, stamped by the drug-registering establishment.
- Pre-clinical including:
o Section A: Table of content
o Section B: Overview of pre-clinical
o Section C: Summary of pre-clinical: Only document
- Clinical including:
o Section A: Table of content
o Section B: Overview of clinical
o Section C: Summary of clinical.
o Section D: List all clinical research
Consulting for drugs registration of BizHub including:
1. Consulting issues related to registration of activities for companies operating in the field of pharmaceuticals.
- Consulting issues related to registration of marketing
- On behalf of customers applying for circulation registration for domestically and internationally-made medicines (registration of drugs).
- Consultation to correct the law
- On behalf of customers applying for import license for drug products not registered for circulation.
2. BizHub Customer Support Services:
- After receiving the registration number or permit, advising on procedures and supporting customers to carry out the necessary procedures for the importation, production and circulation of medicinal products in accordance with the current regulations of the Ministry of Health.
- Advise on procedures and assist clients in changing the name of the product, manufacturer name, trademark, drug life or other information related to products registered for circulation.
If you have any questions about drugs registration, please do not hesitate to call us at (Phone: 028.710 92979, email: firstname.lastname@example.org) for advice on get the procedure and get the best service.