Supplementing the Directive regarding the principles and guidelines of good manufacturing practice for active substances used in medicinal products for human use
In the Official Journal of the European Union L 337 series was published the Delegated Regulation (EU) No. 1252/2014 of the Commission to supplement Directive 2001/83 / EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for active substances used in medicinal products for human use.
Object of regulation: All active substances manufactured in the European Union, including those for export should be manufactured according to the principles and guidelines of good manufacturing practices for active substances currently detailed in the technical guidelines regarding the production of active substances published by the Commission. It is necessary to establish principles and guidelines of good manufacturing practices for active substances in a legally binding document. Thus, this Regulation lays down the principles and guidelines of good manufacturing practice for active substances used in medicinal products for human use, including active substances intended for export.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
:: The source: JURIDICE.ro