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EU GMP Guide – Annex 21: Importation of medicinal products

  • 23 апреля 2020
  • Annex 21, GMP, IMP, import, investigational medicinal product, medicinal products, QP, QP certification, QP confirmation,
Update [21/03/2022] On 21 February 2022, the European Commission (EC) has published a final version of the new Annex 21: Importation of medicinal products of the EU GMP Guide. This new annex comes into operation on 21 August 2022.   Update Due to the challenges posed by COVID-19, the timeline for the targeted consultation has
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Medical Devices Regulation

  • 21 апреля 2020
  • Медицинские устройства, Регламент (ЕС) 2017/745,
On 3 April 2020, the European Commission has adopted a proposal, to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. This proposal therefore postpones, for exceptional reasons in the current context, the application
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