Traduction de «Directives sur les bonnes pratiques analytiques » (Français → Anglais) :

Guidelines on Good Analytical Practice

Guidelines on Good Labelling Practices for Pesticides

good practices in transposing directives

Good Clinical Practice: Consolidated Guideline

The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions of Directive 2001/83/EC, as amended by this Directive, concerning good manufacturing and distribution practices for active substances, concerning detailed rules for medicinal products introduced into the Union without being imported and concerning safety features.

L. whereas an EU CBRN Action Plan should make for the efficient interaction of national and EU initiatives in addressing CBRN risks and in preparing the necessary responses, enhancing both ‘horizontal’ coordination between the Commission and Member States and ‘vertical’ coordination between the EU-level instruments and Member States' instruments, in order to increase the effectiveness and speed of information sharing, the exchange of best practices, analytical reporting at all stages, joint planning, the development of operational procedures, operational exercises and the cost-effective pooling of existing resources ...[+++],

Manufacturers will not be in a position to design development protocols until the technical requirements are published and the adaptations of the Good Clinical Practice Directive and the Good Manufacturing Practice Directive are finalised.

Advanced Therapy medicinal products have specific characteristics that differ greatly from traditional medicinal products. That leads to important differences in their manufacturing process (e.g. in Article 11.4. the GMP Directive requires that sample batches of finished products should be kept for 1 year after expiry date. It is, however, difficult to consider expiry dates for certain classes of ATMPs).