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CHAPTER 2 - KEY FIGURES IN 2019

Veterinary medicines

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EMA is responsible for the scientific evaluation, supervision and safety monitoring of veterinary medicines in the EU. In 2019, EMA recommended 15 medicines for marketing authorisation. Five of these had a new active substance and four were new vaccines. Here are some key figures on the authorisation and safety monitoring of veterinary medicines in 2019. For more detailed information, download the full annual report 2019 (PDF version).

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SUPPORTING RESEARCH AND DEVELOPMENT

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21 Scientific advice requests received
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34 new requests for (re)classification of veterinary medicines intented for MUMS/limited market
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RECOMMENDATIONS FOR MARKETING AUTHORISATION

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23 applications for marketing authorisation received
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15 positive opinions - 1 negative opinion - 5 new active substances
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SAFETY MONITORING OF MEDICINES

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70 thousand adverse drug reactions reported to EudraVigilance
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15 centrally authorised medicines had their product information updated on the basis of new safety data