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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,
On 20 March 2020, the European Commission (EC) released for 3 months consultation (till 20 June 2020) a draft version of Annex 21: Importation of medicinal products of the EU GMP Guide. The draft document is establishing a common understanding of the term importation which is defined as the action of physically bringing medicinal product,
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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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