50 anos de legislação farmacêutica na Europa (1965 – 2015). O caso específico de AIM

Authors

  • Micaela Figueira de Sousa Doutoranda FFUC; CEIS20-Universidade de Coimbra, Portugal
  • João Rui Pita Professor da FFUC; CEIS20-Universidade de Coimbra, Portugal
  • Ana Leonor Pereira Professora da FLUC; CEIS20-Universidade de Coimbra, Portugal

DOI:

https://doi.org/10.14195/1647-6336_14_4

Keywords:

Pharmaceutical Law, Medicines Regulation, Marketing Authorization Application, History of Pharmacy

Abstract

The history of European Union Pharmaceutical Legislation shares the general European ideal of integration and development, with the required adaptations stemming from the ambiguity of medicines as goods and health products. In this study we intend to produce a history of the European law in terms of pharmaceuticals, with the core analytical theme being the marketing authorization application (MAA). The EU Pharmaceutical Legislation emerged in 1965 with the publishing of the Council Directive 65/65/CEE and evolved gradually until today, having as its main goal the implementation of a single market, the protection of Public Health and the best interest of the consumers.

http://dx.doi.org/10.14195/1647-6336_14_4

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Published

2016-02-01

How to Cite

Sousa, M. F. de, Pita, J. R., & Pereira, A. L. (2016). 50 anos de legislação farmacêutica na Europa (1965 – 2015). O caso específico de AIM. Debater a Europa, (14), 73-105. https://doi.org/10.14195/1647-6336_14_4

Issue

No. 14 (2016): Europe, Pharmacy, Medicine

Section

Articles

License

Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows sharing the work with recognition of authorship and initial publication in Antropologia Portuguesa journal.