Wiadomosci lekarskie (Warsaw, Poland : 1960) · 2019
Legal regulation of importation of medicinal products: european standards and national practice.
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Shul'ha Mariya G, Mazur Anatoliy V, Georgiievskyi Iurii V
Аннотация
OBJECTIVE: Introduction: The state policy in the field of medicinal products supply and import adjustment is aimed at steady assurance of quality throughout all stages of medicinal products circulation, starting with production and import to the stage of their medical application. The aim:of the article is to study the existing permitting and restrictive legal mechanisms of importing medicinal products at international, regional and national levels.
PATIENTS AND METHODS: Materials and methods: This research is based on empirical and analytical data from the WHO, EU, EU customs and medical legislation, national legislation of Ukraine and Republic of Poland, Eurostat statistics, European Court of Justice (hereinafter referred to as «ECJ») rulings.
CONCLUSION: Conclusions: Customs regime prohibitions and restrictions are of particular importance when it comes to importing medicinal products. That specificity is in the procedures of licensing, certification, quality control, packaging, marking etc. A proper mechanism for carrying out such procedures requires standardization at international and regional levels. At the level of regional cooperation the issue of parallel import of medicinal products is urgent. Associated risks should be minimized by means of the instruments of international, European law through the adaptation of the national licensing procedures of medicinal products import to the EU requirements, including those defined in the Association Agreements.
PATIENTS AND METHODS: Materials and methods: This research is based on empirical and analytical data from the WHO, EU, EU customs and medical legislation, national legislation of Ukraine and Republic of Poland, Eurostat statistics, European Court of Justice (hereinafter referred to as «ECJ») rulings.
CONCLUSION: Conclusions: Customs regime prohibitions and restrictions are of particular importance when it comes to importing medicinal products. That specificity is in the procedures of licensing, certification, quality control, packaging, marking etc. A proper mechanism for carrying out such procedures requires standardization at international and regional levels. At the level of regional cooperation the issue of parallel import of medicinal products is urgent. Associated risks should be minimized by means of the instruments of international, European law through the adaptation of the national licensing procedures of medicinal products import to the EU requirements, including those defined in the Association Agreements.