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July 14, 2015

PLC Life Sciences Multi-Jurisdictional Guide 2015/16 – Thailand Chapter

Practical Law Company

Practical Law Company has published the latest edition of the PLC Life Sciences Multi-jurisdictional Guide, a Q&A-style guide which provides country-specific analysis of the current regulatory framework surrounding the life sciences industry. Tilleke & Gibbins authored the Thailand chapter of this guide, which looks at pricing and state funding, manufacturing, marketing, clinical trials, advertising, labeling, product recall and liability, patents, trademarks, competition law, patent licensing, generic entry, abuse of dominance, and parallel imports. In particular, the chapter covers the following topics, among others:

  • Pricing: National healthcare, regulation of medicinal product prices, and state funding.
  • Clinical Trials: Regulations, authorizations, consent, trial preconditions, and procedural requirements.
  • Manufacturing: Authorization process, including applications, conditions, restrictions on foreign applicants, key stages and timing, fees, period of authorization and renewals, and monitoring compliance and imposing penalties.
  • Marketing, Sales, and Advertising: Authorization and abridged procedure, parallel imports, restrictions on dealings with healthcare professionals, and restrictions on selling and advertising medicinal products.
  • Packaging and Labeling: Legislation and information requirements.
  • Product Liability: Key regulators, medicinal product safety requirements, liability, defenses, claims, and remedies.
  • Patents: Conditions, scope of protection, validity, revocation, infringement, and remedies.
  • Trademarks: Conditions, scope of protection, validity, revocation, infringement, remedies, and competition law.
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