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Consumer Health protection / Packaging material for food | News | 06 February 2020 | Strasbourg, France
In the framework of its task to develop and strengthen standards and policies to improve the health protection of consumers, the European Committee for Food Contact Materials and Articles (Partial Agreement) (CD-P-MCA), has elaborated a set of general technical provisions to be appended to an upcoming Council of Europe resolution on food contact materials and articles and specific provisions for...
Products and Services | News | 05 February 2020 | Strasbourg, France
The EDQM announces the availability of: • 1 new European Pharmacopoeia (Ph. Eur.) reference standard • 29 replacement batches for Ph. Eur. reference standards
Reference Standard / Collection & Catalogue | News | 31 January 2020 | Strasbourg, France
The Ministry of Health and Family Welfare of India has lifted the ban on Oxytocin reference standards imported exclusively for the purpose of test and analysis. The EDQM is therefore in a position to ship Oxytocin CRS (catalogue code O0700000) to India once again.
European Pharmacopoeia | News | 28 January 2020 | Strasbourg, France
A new web page providing centralised access to all information related to nitrosamine contamination is now available on the EDQM website. It presents a general overview of the issue and provides details of the actions taken in the different sectors of activity concerned: the European Pharmacopoeia, the Certification of Suitability to the monographs of the European Pharmacopoeia, and the network...
Reference Standard / Collection & Catalogue | News | 24 January 2020 | Strasbourg, France
At the present time, a reference standard is withdrawn from the catalogue either on the date that a revised monograph which no longer refers it to becomes applicable, or the date on which a monograph is officially withdrawn from the European Pharmacopoeia.
European Pharmacopoeia / General text/chapter | News | 24 January 2020 | Strasbourg, France
The new Pharmeuropa website is now online with a series of new features available to improve the user experience. As part of its efforts to enhance customer service and taking user feedback into account, the EDQM has redesigned the platform to include the following features: - single sign-on with other EDQM websites using the same authentication database, including Ph. Eur. online and PaedForm...
Patient & Consumer Protection / Anti-falsification activities | News | 22 January 2020 | Strasbourg, France
A recent study carried out within the framework of the Council of Europe MEDICRIME Convention has highlighted shortcomings of current legislative approaches in relation to the protection of patients against falsified medicines in Europe. The study, authored by Domenico Di Giorgio of the Italian Medicines Agency (AIFA), and Diana Russo, Public Prosecutor of Naples, Italy, with the support of the...
European Pharmacopoeia / Monograph | News | 16 January 2020 | Strasbourg, France
The European Pharmacopoeia Commission adopted a new monograph, on Rosuvastatin tablets (3008), at its 163rd session in March 2019. The monograph was published in Supplement 10.1 of the European Pharmacopoeia (Ph. Eur.), available since October 2019, and will become effective on 1 April 2020.
European Pharmacopoeia / Monograph | News | 16 January 2020 | Strasbourg, France
With a view to improving the correspondence between liquid chromatography column brand names (provided in the Knowledge Database) and the reagents used to describe the stationary phases for these columns, an overall review of all the monographs concerned has been launched. The names of the reagents and their definitions have also been reviewed to ensure that these stationary phases are described...
Products and Services | News | 09 January 2020 | Strasbourg, France
The EDQM announces the availability of: 3 new European Pharmacopoeia (Ph. Eur.) reference standards; 13 replacement batches for Ph. Eur. reference standards.
European Pharmacopoeia / Public enquiry | News | 07 January 2020 | Strasbourg, France
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.1 is 31 March 2020. Users and interested parties are welcome to comment on these drafts. It should be noted that: • although draft monographs must not be regarded as official standards, they will, once adopted by the European...
Products and Services | News | 07 January 2020 | Strasbourg, France
The 10.2 supplement of the European Pharmacopoeia is now available and will be applicable in 38 European countries as of 1 July 2020.
European Pharmacopoeia / International harmonisation | News | 20 December 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) general chapter on Pharmacopoeial harmonisation (5.8) provides users with general guidance on the work of the EDQM in this field and details of the information included in harmonised Ph. Eur. general chapters and monographs. This information enables users to understand and correctly apply Ph. Eur. texts (monographs on excipients and general chapters)...
European Pharmacopoeia / General text/chapter | News | 19 December 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 2.8.26 on contaminant pyrrolizidine alkaloids. Users and concerned parties can submit their comments in Pharmeuropa 32.1 until 31 March 2020.
Paediatric Formulary | News | 18 December 2019 | Strasbourg, France
The EDQM is pleased to announce that the European Paediatric Formulary is now available free of charge on a dedicated online platform. This is a major achievement for the PaedForm Working Party and all the stakeholders involved, since it not only embodies several years’ work and dedication to the project, but feeds into the fundamental human right of equal access to quality healthcare.