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Certification of suitability (CEP) / Procedure of certification (general) | News | 21 January 2022 | Strasbourg, France
Supplement 10.8 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 July 2022, and to follow the instructions given below.
Certification of suitability (CEP) | News | 20 January 2022 | Strasbourg, France
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.1. The table below lists the substances affected by these revisions and for which a CEP has been granted.
European Pharmacopoeia / Monograph | News | 20 January 2022 | Strasbourg, France
This document is intended to help stakeholders understand the advantages of applying for a monograph elaboration via European Pharmacopoeia (Ph. Eur.) procedure 4. It describes how Group P4 has elaborated P4 monographs over the last 10 years. It also applies to monographs on biotherapeutics as elaborated by the P4bio Working Party.
Reference Standard | News | 20 January 2022 | Strasbourg, France
Are you an experienced production technician working in the pharmaceutical or a similar area? Do you have the skills to ensure that all operations and documentation comply with Standard Operating Procedures (SOPs) and maintain batch records? Do you have what it takes to act as reference person in the use of equipment or implementation of processes? Are you an excellent team player? If so, this...
Reference Standard / General | News | 18 January 2022 | Strasbourg, France
Are you an experienced production operator, used to working in a pharmaceutical manufacturing environment? Are safety and efficiency your priorities in the workplace? Do you have the skills required to train colleagues and to troubleshoot problems when they arise, and ensure that production is kept on schedule? We are looking for someone like you to contribute directly to providing the quality of...
Paediatric Formulary | News | 14 January 2022 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 4 of Pharmeuropa PaedForm, which contains two texts for public consultation, Simple syrup (preservative-free) and Phosphate 60 mg/mL Oral solution, prior to their inclusion in the European Paediatric Formulary.
European Pharmacopoeia / Monograph | News | 13 January 2022 | Strasbourg, France
Sterility requirements in non-liquid and non-parenterally administered veterinary vaccine monographs have been replaced by a maximum bioburden limit to allow the development of new innovative vaccine presentation forms while maintaining the same safety guarantees.
European network of OMCLs | News | 11 January 2022 | Strasbourg, France
The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted two market surveillance studies on omeprazole and sildenafil, the results of which have been published in the Journal of Pharmaceutical and Biomedical Analysis, Vol. 208 (2021) (doi:10.1016/j.jpba.2021.114444), and the journal Talanta, 239 (2022) (doi:10.1016/j.talanta.2021.123123),...
Certification of suitability (CEP) | News | 10 January 2022 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / Public enquiry | News | 10 January 2022 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapters Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29), published in this quarter’s issue of Pharmeuropa (34.1) for comment (deadline 31 March 2022).
Reference Standard / Collection & Catalogue | News | 07 January 2022 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of 3 new European Pharmacopoeia (Ph. Eur.) reference standards and 11 replacement batches for Ph. Eur. reference standards in December 2021.
Certification of suitability (CEP) | News | 06 January 2022 | Strasbourg, France
The consultation phase of the project to design the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) of the future has been completed.
European Pharmacopoeia / Public enquiry | News | 05 January 2022 | Strasbourg, France
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.1 is 31 March 2022.
European network of OMCLs | News | 22 December 2021 | Strasbourg, France
The Veterinary Batch Release Network (VBRN) for immunological veterinary medicinal products (IVMPs) and the Veterinary Medicines Directorate (VMD), UK, have signed a memorandum of understanding (MOU) to renew the exchange and collaboration on common activities related to batch release of IVMPs post-Brexit. 
EDQM | News | 21 December 2021 | Strasbourg, France
Applications: please send your CV and motivation letter in French to: hr@edqm.eu by 14 January 2022 the latest.