Brexit and EU rules for medicinal products for human use and veterinary medicinal products
- 7 марта 2019
- API, CP, EC, EMA, GMP, MA, MAH, QPPV, RMS, активный фармацевтический ингредиент, АФИ, Брексит, владелец регистрационного удостоверения лекарственного препарата, выпуск серии, выход Великобритании из ЕС, готовая продукция, готовый препарат, действующее вещество, держатель регистрационного удостоверения лекарственного препарата, ЕАЛС, Европейская комиссия, Европейское агентство лекарственных средств, ЕК, изменение в регистрационном удостоверении лекарственного препарата, импорт, лекарственное средство, лекарственный препарат, место, НПП, передача регистрационного удостоверения на лекарственный препарат, переходный период, правовые последствия, производство, регистрационное удостоверение лекарственного препарата, уведомление,
DO NOT RELY ON THE TRANSITION PERIOD!
In view of the uncertainties surrounding the ratification of the Withdrawal Agreement, all interested parties, and especially economic operators, are reminded of legal repercussions, which need to be considered when the United Kingdom becomes a third country.
The European Commission have published revised versions of Notice to stakeholders and Questions and Answers (Q&As) documents in 22 official EU languages.
The list of Questions and Answers (Q&As) complements the Notice to stakeholders and addresses a situation where the United Kingdom becomes a third country on 30 March 2019 („the withdrawal date”) without a withdrawal agreement and hence without a transition period provided for in the draft Withdrawal Agreement.
DO NOT RELY ON THE TRANSITION PERIOD!
DOCUMENTS:
DO NOT RELY ON THE TRANSITION PERIOD!
Sources: EC, EMA
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