Healthcare & Life Sciences

In the life sciences sector, even the best product in the world cannot reach Vietnamese consumers without the requisite licence, declaration number or properly prepared registration dossier. This is a sector in which specialised regulations govern every stage of a product’s lifecycle, and where the gap between written regulations and the regulatory authorities’ actual dossier review practices can determine whether a product reaches the market months earlier or later. HM&P works within this very gap on a daily basis.

We advise multinational pharmaceutical and medical device corporations, cosmetics companies, distributors and healthcare investors across the entire chain of operations in Vietnam, from market entry and product commercialisation to distribution, advertising and ongoing compliance throughout the course of business. Our experience spans pharmaceuticals, cosmetics, medical devices, health supplements and specially regulated chemicals—product categories that are each subject to their own regulatory framework, competent authority and distinct licensing practice.

Our Approach

The value we deliver does not lie in merely listing regulatory conditions, but in designing the fastest and most reliable route to market for each product: determining the correct product classification, where the boundaries between cosmetics, pharmaceuticals, medical devices and health supplements often determine the entire regulatory burden; structuring dossiers in line with the regulatory authorities’ review expectations; handling requirements relating to foreign-issued documents, including Certificates of Free Sale (CFS), Letters of Authorisation (LOA), consular legalisation and Apostille; and anticipating common issues, ranging from inconsistencies across supporting documents to corporate changes such as changes of address or restructurings that may have consequential effects on the validity of existing licences.

Once a product is placed on the market, we advise clients on operational risks, including the legal boundaries governing advertising and product claims, trade promotion programmes, interactions with healthcare professionals and, in particular, post-market surveillance, sector-specific inspections, suspension of circulation and product recalls, where the speed of response and the manner of engagement with regulatory authorities can determine the extent of commercial and reputational damage.

The regulatory framework governing this sector is also evolving rapidly. We closely monitor new legislation from the drafting stage in order to provide clients with early warning of potential impacts on their product portfolios and business models.

Scope of Services

• Market entry and investment conditions in the pharmaceutical, medical device, cosmetics and healthcare sectors;
• Company establishment, applications for sector-specific licences and certificates of eligibility for business operations;
• Product classification and market access strategy, including registration, declaration and marketing authorisation;
• Foreign-issued documentation, including CFS, LOA, powers of attorney, consular legalisation and Apostille;
• Import, export, manufacturing, contract manufacturing and distribution models, including distribution restrictions applicable to foreign-invested enterprises;
• Product labelling, advertising, product claims and trade promotion activities;
• Sector-specific agreements, including distribution, licensing, manufacturing, research and supply agreements;
• Compliance programmes, interactions with healthcare professionals and risk prevention in commercial activities;
• Post-market surveillance and crisis management, including sector-specific inspections, suspension of circulation, product recalls and quality alerts;
• Commercial disputes and legal issues arising throughout the distribution and business chain.