EU GMP Guide – Annex 21: Importation of medicinal products

23 April 2020
Annex 21, GMP, IMP, import, investigational medicinal product, medicinal product, 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

Medical Devices Regulation

21 April 2020
2017/745, medical devices, regulation,

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

Coronavirus disease (COVID-19)

3 April 2020
Article 83(3) of Regulation (EC) No 726/2004, azithromycin, chloroquine, clinical data, clinical trials, common logo, compassionate use, coronavirus, COVID-19, CT, disease, efficacy, falsified, guidelines, heart rhythm problems, hydroxychloroquine, IMP, interferon beta, investigational, lopinavir, medicines, MERS-CoV, monoclonal antibodies, nonclinical data, online, pandemic, pharmacies, prevent, remdesivir, ritonavir, safety, SARS-CoV, SARS-Cov-2, treat, treatments, vaccine, Veklury, WHO,

Treatments and vaccines against COVID-19 Update [03/07/2020] Remdesivir (Veklury) is the first authorised medicine in the EU to treat COVID-19! Update [02/07/2020] The first COVID-19 treatment has been recommended for EU authorization! EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir). EMA is urging the general