LEGAL FRAMEWORK OF GOOD MANUFACTURING PRACTICE (GMP) FOR VETERINARY MEDICINAL PRODUCTS IN THE EU: EXPERIENCE FOR UKRAINE

I Berezovska

Abstract


Abstract. The article comprehensively analyzes current legislation of the European Union on Good Manufacturing Practice (GMP) for veterinary medicinal products in
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particular the provisions of Directives No. 91/412 and No. 2001/82, and describes GMP main elements. It is noted that as a result of EU-Ukraine Association Agreement signing a new stage in the development of Ukrainian legislation regarding the turnover of veterinary medicinal products has begun, which is characterized by the increased impact of EU law on the legal regulation of this industry. The state of the appropriate national legislation reforming was analyzed. It was proved that today the main directions of such reforming are related to the integrated introduction of Good Manufacturing Practice and to the restoration of the production of veterinary medicinal products licensing. The importance of prompt and effective completion of these reforms which will have significant consequences not only for the national pharmaceutical industry, but also for the protection of the health of animals and people in general, was underscored. It was emphasized that the scale of the obligations undertaken by Ukraine to harmonize the legislation on the circulation of veterinary medicinal products requires prompt and qualified organizational work by the Ukrainian competent authorities.
Key words: European Union, Association agreement, veterinary medicinal products, harmonization of legislation, licensing of the production of veterinary medicinal products, good manufacturing practice (GMP).


References


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DOI: http://dx.doi.org/10.17721/apmv.2018.137.0.65-76

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