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[The new norms decreed by the legislative dirrective 91-93 CCE]
1Dipartimento di Chimica e Tecnologie Farmaceutiche, Univeristà degli Studi di Palermo.
Bollettino Chimico Farmaceutico
|May 22, 1998
Summary
Community law now governs the pharmaceutical industry, from drug manufacturing to marketing. Italian legislation has evolved since 1965, with recent decrees acknowledging key European directives and emphasizing pharmacovigilance.
Area of Science:
- Pharmaceutical Law
- Regulatory Affairs
- Health Policy
Context:
- European Union (EU) law increasingly governs the pharmaceutical sector.
- Italian pharmaceutical legislation has progressively integrated EU directives since 1965.
- Recent legislative changes in 1997 incorporated specific EU directives (93/39/EEC, 65/65/EEC, 75/318/EEC, 75/319/EEC).
Purpose:
- To detail the evolution of Community law in the pharmaceutical industry.
- To examine the acknowledgment of specific EU directives within Italian legislation.
- To highlight the significance of pharmacovigilance regulations.
Summary:
- The pharmaceutical industry is subject to comprehensive Community law, covering manufacturing through marketing.
- Italian law has adopted EU directives, notably Decree Law of February 1997, amending regulations for human medicinal products.
- The importance of pharmacovigilance is underscored within this regulatory framework.
Impact:
- Provides a clear overview of the regulatory landscape for pharmaceutical products in Italy and the EU.
- Emphasizes the critical role of pharmacovigilance in ensuring drug safety and public health.
- Serves as a reference for understanding the legal framework governing pharmaceutical operations.
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