Reglementarea şi practica jurisprudenţială europeană cu privire la autorizarea punerii pe piaţă a medicamentelor pentru uz uman şi veterinar
European jurisprudential regulation and practice regarding the marketing authorization of medicinal products for human and veterinary use

Summary/Abstract: This study discusses the issue of authorizations for medicines in the European Union and the Member States. The issue regarding the use of generic medicines is topical and interesting in terms of the requirement that human and veterinary medicines meet the requirements of EU legislation in this field. For this purpose, Community legislation (Directive 2001/83/EC) has been developed to address the concern that any regulation on the production and distribution of medicinal products should pursue the safeguarding of public health and the abridged procedure established by this directive ensures the rigor of the safety and efficacy rules of medicines use.

• Details
• Contents