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Patient & Consumer Protection / Pharmaceutical care | News | 15 December 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a webinar illustrating the content of Council of Europe Resolution CM/Res(2020)3 on the implementation of pharmaceutical care for the benefit of patients and health services, which aims to support member states interested in implementing pharmaceutical care in Europe. In line with the above resolution,...
European network of OMCLs / Human Biologicals (OCABR) / Vaccines | News | 14 December 2020 | Strasbourg, France
The Official Control Authority Batch Release (OCABR) network for human vaccines and the Therapeutic Goods Administration (TGA), Australia have signed a memorandum of understanding (MOU) to increase the exchange and collaboration on common activities related to batch release of human vaccines. 
Reference Standard / Collection & Catalogue | News | 14 December 2020 | Strasbourg, France
To support the implementation of the newly adopted general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42., previously listed as 2.4.36.), seven reference standards have been established and are available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
European Pharmacopoeia / Monograph | News | 10 December 2020 | Strasbourg, France
Over the last few years, the European Pharmacopoeia (Ph. Eur.) has been elaborating monographs on medicinal products containing chemically defined active substances, applicable to immediate-release solid dosage forms (tablets, capsules).
Transfusion / Blood Quality Management system (B-QM) | News | 08 December 2020 | Strasbourg, France
A conference celebrating 10 years of co-operation between the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Commission (EC) in the field of blood transfusion shed light on the challenges faced by blood establishments (BEs) in securing sustainable blood supplies and a resilient blood transfusion sector in Europe.
European Pharmacopoeia / Ph. Eur. Commission | News | 07 December 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36).
European Pharmacopoeia / Ph. Eur. Commission | News | 04 December 2020 | Strasbourg, France
The 168th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 24 and 25 November 2020. At this session, the Commission adopted 114 texts for publication in Ph. Eur. Supplement 10.6, including 101 revised texts and 13 new texts.
Reference Standard / Collection & Catalogue | News | 02 December 2020 | Strasbourg, France
The EDQM announces the availability of 12 new European Pharmacopoeia (Ph. Eur.) reference standards and 9 replacement batches for Ph. Eur. reference standards.
Reference Standard / Collection & Catalogue | News | 30 November 2020 | Strasbourg, France
Starting 1 January 2021, specific permits will be required to order R0250000 – Residual solvent solution class 1 CRS. Reference standard R0250000 – Residual solvent solution class 1 CRS contains 2 controlled substances (Carbon tetrachloride and 1,1,1–Trichloroethane).
EDQM's response to COVID-19 | News | 23 November 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines.
Products and Services | News | 18 November 2020 | Strasbourg, France
Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the EDQM offices from 23 December 2020 (12 noon CET) to 4 January 2021 (8 a.m. CET).
Certification of suitability (CEP) / Procedure of certification (general) | News | 13 November 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
EDQM's response to COVID-19 | News | 12 November 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are...
Reference Standard / Collection & Catalogue | News | 09 November 2020 | Strasbourg, France
The EDQM announces the availability of: 8 new European Pharmacopoeia (Ph. Eur.) reference standards and 24 replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) | News | 05 November 2020 | Strasbourg, France
CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 32.4.