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Good distribution practices for active substances for medicines for human use No. 2015 / 10 Bis

These guidelines are based on Article 47 fourth paragraph of Directive 2001 / 83 / EC of the European Parliament and of Conseil1. They follow the principles on which the guidelines are also based on the volume of 4 EudraLex, Part II, Chapter 17, regarding the distribution of active substances and the guidelines of November 5 2013 on good distribution practices wholesale medicines for human use.


EudraVigilance stakeholder management plan changes

THis paper details the exchange 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 exchanges are Being brought` about by the exchange to post-permission and clinical trials legislation.

The Intended audience of this paper are the National Competent Authorities (NCAs) Marketing Authorisation Holders (MAHs), sponsors of clinical trials and the EMA. This paper details the IT & business exchange Being made at Both European and stakeholder level.


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

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 multiple-dose in, 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.


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

Medicines regulatory systems worldwide-have always depended upon the knowledge of organisms That develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is a trust entre les regulator and the regulated que le Information submitted in folders and used in day-to-day decision-making is comprehensive, complete and reliable.

Data on qui thesis decisions are based shoulds The Therefore be full as well as Being accurate, legible, contemporaneous, original and Attributable; Commonly Referred to as "ALCOA".


Annex 16: Certification by a Qualified Person and Batch Release

The Annex has-been revised to Reflect the globalization of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has-been the 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 release implements ICH aussi Q8, Q9 Q10 and documents, and interpretation documents, Such As the manufacturing and import permission (MIA) interpretation document as applicable. Also, Some areas, Where the interpretation by Member States Has not beens consist-have-been Clarified.

Deadline for coming into operation: 15 April 2016.


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