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Certification of suitability (CEP) / Procedure of certification (general) | News | 16 September 2019 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Products and Services | News | 05 September 2019 | Strasbourg, France
The EDQM announces the availability of: • 2 New Ph. Eur. reference standards, • 18 Replacement batches for Ph. Eur. reference standards.
European Pharmacopoeia / General | News | 05 September 2019 | Strasbourg, France
The Council of Europe has played a pioneering role in a number of fields, some better known to the public than others. One such area is medicines and healthcare, with the creation of the European Pharmacopoeia 55 years ago.
European Pharmacopoeia / Monograph | News | 03 September 2019 | Strasbourg, France
The 10th Edition of the European Pharmacopoeia, which is applicable in 38 European countries from 1 January 2020 and is used in over 100 countries worldwide, is now available!
Transplantation / European Organ Donation Day (EODD) | News | 30 August 2019 | Strasbourg, France
The EDQM/Council of Europe organises the European Day for Organ Donation and Transplantation (EODD) every year in a different country to raise awareness on the importance of organ donation, as a way of saving and improving lives.
Products and Services | News | 06 August 2019 | Strasbourg, France
The EDQM announces the availability of: • 11 new Ph. Eur. reference standards • 28 replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue. Information on change of sales units. Information on changes of storage / shipping conditions. Information on reference standards currently out of stock. The Ph. Eur. Reference Standards...
Certification of suitability (CEP) / Procedure of certification (general) | News | 22 July 2019 | Strasbourg, France
CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2020 in the 10th Edition of the Ph. Eur., and to follow the instructions given in the document.
Certification of suitability (CEP) / Procedure of certification (general) | News | 17 July 2019 | Strasbourg, France
The EDQM has revised the following documents to reflect current practice and clarify a couple of items: - Terms of reference; - Code of Practice for the Certification procedure.
European Pharmacopoeia / Public enquiry | News | 15 July 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the mandatory dosage form monographs. As part of this process, its Group of experts 12 has revised or elaborated several texts involving preparations which are applied to the skin and one involving intravesical preparations. These proposed revisions have been published in Pharmeuropa 31.3 and concern the following texts...
European Pharmacopoeia / General text/chapter | News | 15 July 2019 | Strasbourg, France
At its 162nd session in November 2018, the Ph. Eur. Commission adopted a new version of one of its major general methods. Ultraviolet and visible absorption spectrophotometry (2.2.25) has undergone extensive revision and is published in the 10th Edition (implementation date 1 January 2020).
Certification of suitability (CEP) / Procedure of certification (general) | News | 15 July 2019 | Strasbourg, France
According to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications. Therefore, all such submissions need to be in eCTD format.
European Pharmacopoeia / Public enquiry | News | 12 July 2019 | Strasbourg, France
All new texts and texts having undergone technical revisions are published in Pharmeuropa for public consultation. 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 Pharmacopoeia Commission at a later date, become applicable and legally...
EDQM / All activities | News | 09 July 2019 | Strasbourg, France
The international conference “EDQM & European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines” took place on 19 to 20 June 2019 in Strasbourg to mark the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th Anniversary of the European OMCL Network and of the Certification of Suitability Procedure.
European Pharmacopoeia / Ph. Eur. Commission | News | 08 July 2019 | Strasbourg, France
Following the election of its new Chair, Prof. Torbjörn Arvidsson, at its March session, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Salvador Cañigueral as its first Vice-chair for a term of three years (2019-2022). Mr Goran Benkovic was elected as second Vice-chair.
European Pharmacopoeia / Monograph | News | 08 July 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new monograph on Rosuvastatin tablets (3008) at its 163rd session (March 2019). The monograph will be published in the 1st supplement to the 10th Edition (available in October 2019) and will become effective on 1 April 2020.