Bonnes pratiques de distribution des substances actives des médicaments à usage humain N°2015/10 Bis

Les présentes lignes directrices sont fondées sur l’article 47, quatrième alinéa, de la directive 2001/83/CE du Parlement européen et du Conseil1 . Elles suivent les principes sur lesquels reposent également les lignes directrices du volume 4 d’EudraLex, partie II, chapitre 17, en ce qui concerne la distribution de substances actives et les lignes directrices du 5 novembre 2013 concernant les bonnes pratiques de distribution en gros des médicaments à usage humain .

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EudraVigilance stakeholder change management plan

This document details the changes taking place in the EudraVigilance system and to the process of reporting Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs). These changes are being brought about by changes to the post-authorisation and clinical trials legislation. 

The intended audience of this document are the National Competent Authorities (NCAs), Marketing Authorisation Holders (MAHs), sponsors of clinical trials and the EMA. This document details the IT & business changes being made at both European and stakeholder level. 

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Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products

This guidance provides industry with the Food and Drug Administration’s (FDA’s) recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers. Specifically, this guidance provides FDA’s revised definitions for single-dose and multiple-dose containers, and introduces the definition of a new package type term, “single-patient-use” container. 

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Guidance on Good Data and Record Management Practices (September 2015) Draft for comment

Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is a trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable. 

Data on which these decisions are based should therefore be complete as well as being accurate, legible, contemporaneous, original and attributable; commonly referred to as “ALCOA”.

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Annex 16: Certification by a Qualified Person and Batch Release

The Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified.

Deadline for coming into operation: 15 April 2016. 

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