Working with Regulations in Foreign Countries, with Emphasis on Good Manufacturing Practice for Herbal Medicines

Abstract

This article provides an overview of legislative differences among countries. There are two basic types of legal systems: common-law (also called Anglo-American legal systems) and civil law. A nation’s culture is reflected in its law. In most countries, laws and regulations include a preamble, a dictum, and an explanatory memorandum. The dictum, which contains the articles, is the most important part. The dictum includes definitions, realm or scope, and the rules in stricto sensu.

Closely reading the definitions is important. For example, in the European Union, it is important to know the definition of herbal products in order to determine whether the herbal regulations apply. Determining the scope of the regulation is also necessary in order to determine whether a regulation is applicable.

In many countries, little attention was paid to herbal medicines during the second half of the twentieth century, when most pharmaceutical legislation and licensing procedures were developed. Thus, many countries have less specific regulations for herbal medicines than for pharmaceuticals. Today, there is renewed interest in herbal medicines. Many countries are preparing new legislation on herbal medicines.

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References

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    European Medicine Evaluation Agency. Note for Guidance on Quality of Herbal Medicinal Products of the European Union. (EMEA/HMPWG/9/99) London, United Kingdom: European Medicine Evaluation Agency; 1999.

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    World Health Organization. The Regulatory Situation of Herbal Medicines: A Worldwide Review. Geneva, Switzerland: World Health Organization; 1998.

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Correspondence to Willem K. Scholten MSc, Pharm, MPA.

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This article is an expanded version of a presentation made by the author at the DIA 37th Annual Meeting, July 8-12, 2001, in Denver, Colorado.

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Scholten, W.K. Working with Regulations in Foreign Countries, with Emphasis on Good Manufacturing Practice for Herbal Medicines. Ther Innov Regul Sci 36, 51–55 (2002). https://doi.org/10.1177/009286150203600109

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Key Words

  • Law
  • Legal systems
  • Hierarchy
  • Herbal regulations
  • Good Manufacturing Practice