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GMP: New Guideline for Recall of IMPs

02.10.2014
The European Commission DG Health & Consumers has published the new EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. ...

EMA: Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products

02.10.2014
This guideline describes the information to be included in the summary of product characteristics (SmPC) for human plasma-derived and recombinant coagulation factor-IX products, which are ...

EMA: Policy on veterinary medicines for minor use, minor species / limited market revised

25.09.2014
The European Medicines Agency has revised the operation of its minor-use-minor-species (MUMS) / limited-market policy for veterinary medicines to direct its assistance to those medicines most ...

EMA: Guideline on bioanalytical method validation

25.09.2014
This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative ...

EMA: Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module III on pharmacovigilance inspections and of module VI on the management and reporting of adverse reactions reports

25.09.2014
This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product or Population-Specific Considerations. ...

EMA: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products

25.09.2014
This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and chapter 3 of Regulation (EC) No726/2004 [REG], which are applicable to competent ...

EMA: Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections

25.09.2014
This Module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties in volved. General ...

FDA: Q4B - Annex 6 Uniformity of Dosage Units General Chapte

25.09.2014
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

GMP: Complaints and Recalls: new EU-GMP Chapter 8 published

25.09.2014
The European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been revised completely. ...

EMA: New legislation for veterinary medicines

11.09.2014
European Medicines Agency welcomes European Commission proposal to increase availability of medicines across Europe. New rules have been proposed by the European Commission to improve the health ...