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URPL: EudraVigilance System - Communication

11.10.2011
On 1 July 2011 the European medicines Agency (EMA) has published the format, in which by 2 July 2012 pharmaceutical companies shall submit information on all of the medicines for human use ...

TOPRA: European Commision v Republic of Poland

11.10.2011
Failure of a Member State to fulfil obligations - Directive 2001/83/EC -Article 6 -Marketing authorisation - Article 5 - Exclusion from provisions of directive for medicinal products ordered for ...

EMA: Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

04.10.2011
The Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005) lays down the ...

EMA: Guideline on core SmPC and Package Leaflet for Radiopharmaceuticals

04.10.2011
This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for Radiopharmaceuticals. ...

EMA: Guideline on quality of herbal medicinal products/traditional herbal medicinal products

04.10.2011
This guideline intends to cover the general quality aspects of herbal medicinal products (for human and veterinary use), including traditional herbal medicinal products for human use. The special ...

EMA: Reflection Paper on risk based Quality Management in Clinical Trials

04.10.2011
The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of ...

FDA: Time and Extent Applications for Nonprescription Drug Products

04.10.2011
This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the¬counter (OTC) ...

FDA: Self-Selection Studies for Nonprescription Drug Products

22.09.2011
This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A ...

GMP: EMA publishes two advisory Documents addressing a Number of Questions about centralised Admission Procedures

22.09.2011
The EMA has recently published two documents concerning the centralised application procedures for new, generic and hybrid medicinal products. In the Q&A section on its website the European ...

TOPRA: EU Module 1 v1.4.1 Specification

22.09.2011
This document specifies Module 1 of the electronic Common Technical Document (eCTD) for the European Union (“EU”). ...