Vietnam is becoming a key market for the pharmaceutical industry in Asia, driven by a population of more than 100 million people, increasing healthcare demand, and stable growth potential in the coming years. Especially with a significant market share for imported products.
However, for a product to be legally circulated in Vietnam, enterprises are required to obtain a Marketing Authorization granted in accordance with the regulations of the Drug Administration of Vietnam – Ministry of Health. This is not only a core and mandatory legal requirement but also a foundation to ensure that enterprises can carry out importation, distribution to hospitals and pharmacies, participate in bidding, and implement stable and long-term business activities. The registration process requires a complete technical dossier for the competent authority to comprehensively evaluate the quality, safety, and efficacy of the product. Therefore, delays or failure to comply with regulatory requirements may lead to refusal of the license, product recall, administrative penalties, or disruption to business plans.
Challenges commonly faced by enterprises
First, the time for drug registration in Vietnam is often quite long from the moment the dossier is first submitted until a drug registration number is granted. Average registration timelines: Generic drugs: 18–24 months; New drugs/originator drugs: 24–36 months; Biological products/Vaccines: 24–48 months. In practice, the process may take longer depending on the nature of the product dossier and the process of amendments and supplements of documents by the registrant in response to requests from the regulatory authority during the dossier evaluation period.
Second, foreign enterprises are required to have a Representative Office and must meet the conditions for pharmaceutical business in Vietnam in order to directly hold the drug registration. Or they may authorize a drug trading establishment (Distributor) in Vietnam to hold the registration. Both options have certain limitations. For small manufacturers or manufacturers newly entering the Vietnamese market, maintaining a Representative Office in Vietnam may involve considerable costs. Meanwhile, authorizing a Distributor means being completely dependent on that Distributor; if the enterprise wishes to change the Distributor, it must carry out the registration procedure again.
Third, the dossier does not meet technical standards.
A pharmaceutical registration dossier requires a high level of detail and legal compliance; failure to standardize documents in the correct format, language, consular legalization requirements, or updated regulations may result in the dossier being requested to be amended or supplemented multiple times.
Fourth, lack of experience in handling requests for additional information during the evaluation process.
During the evaluation process, if the enterprise does not respond appropriately or fails to provide the required supplementary documents in a timely manner as requested by the regulatory authority, the dossier may face prolonged processing time or refusal of the license.
Finally, after obtaining the drug registration number, the importation and trading activities of the registration holder are still subject to many regulatory requirements and related legal responsibilities: drug prices must be declared and a pharmacovigilance system must be in place. In addition, the drug registration number is valid for five years, therefore, maintaining and renewing the registration must also be carried out regularly and in a timely manner.
MedNovum – Strategic legal partner for marketing authorization in Vietnam
As a pioneer in providing marketing authorization consulting services in the Vietnamese market, MedNovum has experience cooperating with many international partners and manufacturers, and possesses extensive understanding of the legal system and regulatory framework governing pharmaceutical products and medical devices.
Our professional team includes pharmacists, lawyers, engineers, and consultants. This multidisciplinary coordination enables us to support clients in preparing dossiers in a structured manner, minimizing legal risks, optimizing dossier processing time, and building a solid compliance foundation when entering and developing business activities in the Vietnamese market.
Pharmaceutical marketing authorization services provided by MedNovum:
- Consulting on product classification and determining the appropriate registration pathway
- Preparing, reviewing, and finalizing marketing authorization dossiers
- Supporting enterprises in dossier submission and working with regulatory authorities
- Monitoring the evaluation process and handling requests for amendments and supplements
- Carrying out procedures for renewal, modification, and supplementation of the Marketing Authorization after approval
Please provide product information so that the MedNovum team can conduct a preliminary feasibility assessment and propose an appropriate registration roadmap in accordance with Vietnamese law.
We commit to providing timely responses with clear, transparent analysis and practical orientation for the Client’s market entry plan.