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Polish Ministry of Health: The Regulation of Polish Minister of Health of September 18, 2014 concerning variations in marketing authorization of veterinary medicinal product.

09.10.2014
This document is the Regulation of Polish Minister of Health of September 18, 2014 concerning variations in marketing authorization of veterinary medicinal product. ...

EMA: Draft guideline on regulatory acceptance of 3R (Replacement, Reduction, Refinement) testing approaches

09.10.2014
In accordance with Directive 2010/63/EU, the principle of the 3Rs (Replacement, Reduction and Refinement) needs to be considered when selecting testing approaches to be used for regulatory testing ...

RAPS: FDA Announces Major Regulatory Changes, With Specialization a Key Focus

09.10.2014
Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of ...

EMA: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

09.10.2014
Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of ...

EMA: Guidebook for tenderers: Submitting a tender in response to a procurement procedure organised by European Medicines Agency

02.10.2014
This document is designed to help tenderers to submit their tenders in response to procurement procedures issued by the Agency for the supply of goods and services and also for works. ...

EMA: Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use

02.10.2014
The European Medicines Agency (EMA) has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in its Committee for Medicinal Products for Human Use ...

EMA: Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome

02.10.2014
This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of patients with Irritable Bowel Syndrome (IBS). ...

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 ...

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