Rx-360 Summary of the The European Commission's Recently Issued Two Final Guidances in Support of the EU Falsified Medicines Directive

The European Commission has recently issued two final guidances in support of the EU Falsified Medicines Directive.

The Guidelines on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use indicates that the appropriate GMP for excipients of medicinal products for human use are to be determined on the basis of a formalized risk assessment outlined in the guidelines. 

The risk assessment is to take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The MAH should have the risk assessment/management document for appropriate GMP for excipients available on site for review by GBMP inspectors. A risk assessment as set out in these guidelines should be carried out for excipients for authorized medicinal products for human use by 21 March 2016.

The Guidelines on Principles of Good Distribution Practice GDP of Active Substances for Medicinal Products for Human Use follow the same principles that underlie the guidelines of EudraLex Volume 4, Part II, Chapter 17, with regard to the distribution of active substances and the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use. These guidelines provide stand-alone guidance of GDP for importers and distributors of active substances for medicinal products for human use. These guidelines do not apply to intermediates of active substances. Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015.

To View or Download the Guidance on Risk Assessments for Excipients, Click Here

To View or Download the Guidance on GDP for APIs, Click Here

To View or Download the Rx-360 Summaries of the Guidances, Click Here