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Pharmaceutical industry Brexit preparedness and its legal consequences for MAH

  • 13 ноября 2017
  • API, CMDh, CMDv, CP, DCP, EC, EMA, GMP, MA, MAH, MRP, 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, правовые последствия, производство, регистрационное удостоверение лекарственного препарата, уведомление,

ASE Pharma Solutions

On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, stating: “The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that unless the withdrawal agreement establishes another date or the period is extended by the European Council in accordance with Article 50(3) of the Treaty on European Union, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). The United Kingdom will then become a ‚third country’.”

CMDh and CMDv also published similar Notices to marketing authorisation holders of national authorised medicinal products for human (on 2 May 2017) and veterinary use (on 30 June 2017), where “national” means authorised following decentralized, mutual recognition or purely national procedure.

In this regard, marketing authorisation holders are reminded of certain legal consequences that need to be considered in a timely manner. Preparing for the consequences of the UK’s withdrawal from the Union is not just a matter for European and national administrations, but also for private parties. It is important that industry stakeholders work together, with the European Medicines Regulatory Network, to prepare for the UK’s withdrawal from the EU and the possible impact this may have on the industry and the availability of medicines in Europe.

Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union. It was recognised that the impact will vary from one company to another depending on their product portfolio and organisation.

In particular, the Commission and the European Medicines Agency as well as CMDh and CMDv expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.

The industry associations have also identified a number of areas that require urgent impact assessments by companies so that they can take appropriate actions to ensure their marketing authorisations remain valid, once the United Kingdom has left the Union.

MAH established in UK

API manufacturing site is located in UK

FP manufacturing site is located in UK

Batch release site is located in UK

QPPV resides in UK


And what if your RMS for MRP or DCP is the UK?

Updated: 2019-02-27