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  Pharmaceuticals

| April 13, 2015 04:36 pm

Vietnam, is a developing country with over 86 million people and is a market with great potential for pharmaceutical business. Vietnam has signed up to a number of international commitments to integrate and standardize pharmaceutical regulations but also has specific laws and regulations applicable to pharmaceuticals.  These include conditions on doing business in pharmaceuticals, product registration and approvals, permits and conditions on advertising and promotion, labelling compliance, clinical trial studies and so on.  Our Regulatory Practice team can provide you with a full range of services to succeed in the Vietnamese pharmaceutical market.  These services include:

Registration & Approval

  • Advice on regulations, rules, provisions, conditions with regard to production, sales, import, and export of pharmaceutical products in Vietnam.
  • Advice and assistance in getting new approval/ licenses and renewal of licenses for the operation of pharmaceutical companies in Vietnam with a focus on foreign pharmaceutical companies.
  • Advice and assistance in participating in pharmaceutical bidding tenders, and adding products into the list of essential medicines or national insurance.
  • Advice and assistance in obtaining approvals/ licenses and organisation in conducting clinical trial studies, bio-availability and bio-equivalence studies for pharmaceutical products in Vietnam.
  • Advice and assistance in the preparation of application dossiers then follow-up of the evaluation process for the purpose of getting licenses and approvals from the Drug Administration of Vietnam with regard to the registration of new products, renewals, changes and variations.
  • Translation and conversion of documents with a focus on preparing label artwork, pack inserts, and product information leaflets in Vietnamese in conformity with the legal regulations of Vietnam.
  • Advice and assistance in pharmaceutical post marketing surveillance, pharmacovigillance as well as adverse reaction reports (ADR), product quality test, and other areas.
  • Advice and assistance in all regulatory matters in Vietnam.

Advertising, Promotion, and Labelling

  • Advice on conditions, requirements and procedures applicable to advertisement and/or promotion programs in the pharmaceutical industry.
  • Advice and assistance in preparing application dossiers to obtain permits for advertising, promotion programs and campaigns for pharmaceutical products.
  • Submission and obtainment of approvals/ licenses for advertising, product information and promotion programs.
  • Advice on product labelling in order to be in compliance with Vietnamese law.
  • Other relevant matters.

Operation Compliance

  • Comprehensive advice on regulatory affairs and other legal aspects, requirements and conditions of doing business in pharmaceuticals including import & export, manufacture and sales, medical representatives, free-of-charge products, custom clearance, safety surveillance and reports.
  • Legal advice on competition, intellectual property, counterfeit and infringing products, patented and off-patent products.
  • Advice and assistance in Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP), and Standard Operation Procedures, (SOP).
  • Compliance legal due diligence to find out any problems, matters and advice, and assistance in remedying the same in accordance with Vietnamese law.
  • Advice, assistance and representation  in handling complaints, adverse reactions and side effects, insurance claims relating to use of medicines, drugs, and pharmaceutical preparations.
  • Advice and assistance with all other regulatory matters during the operation of your pharmaceutical businesses in Vietnam.