News
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN for veterinary medicinal products
17.11.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN
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EMA: Regulatory information – Updated SME user guide now available
20.10.2016
The European Medicines Agency (EMA) has updated its user guide for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. The guide aims to support SMEs to better
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EMA: Concept paper for the revision of the note for guidance on the use of adjuvanted veterinary vaccines
29.09.2016
The Immunologicals Working Party (IWP) recommends revisiting the contents and replacing the note for guidance on the use of adjuvanted veterinary vaccines with a new guideline, to take into
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EMA: Guideline on user safety of topically administered veterinary medicinal products
30.06.2016
Applications for marketing authorisations for veterinary medicinal products (VMPs) in the European Union are issued in accordance with Directive 2001/82/EC as amended by Directive 2004/28/EC and
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EMA: Draft guideline on the plant testing strategy for veterinary medicinal products
09.06.2016
Plant toxicity tests are used in the terrestrial environmental risk assessment of veterinary medicinal products (VMPs) as described in the VICH guideline on environmental impact assessment for
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 30, 2015 on the the fulfillment by responsible entities from the obligation referred to in Article 24 paragraph 1 point 4 l
04.04.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 30, 2015 on the the fulfillment by responsible
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EMA: Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
17.02.2016
In order to stimulate the development of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 21, 2015 concerning the publication of the Regulation of the Minister of Health of 8 July 2015 on the method of determinatio
23.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 21, 2015 concerning the publication of the Regulation
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EMA: Draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals
19.03.2015
This guideline provides advice in regards to applications for marketing authorisations for antimicrobial veterinary medicinal products on the data required and the methodology to be used for
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EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances
19.03.2015
This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate
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