Food contact materials and articles: new documents for consultation

EDQM 06/02/2020 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...

Read More

1 new reference standard and 29 replacement batches released in January 2020

EDQM 05/02/2020 Strasbourg, France

New releases: New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Change of EDQM storage/shipping conditions Change in the policy for withdrawing reference standards from sale Information for Indian users Shipments to...

Read More

Shipment of Oxytocin CRS to India

EDQM 31/01/2020 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.

Read More

Nitrosamine contamination: new web page on EDQM response

EDQM 28/01/2020 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...

Read More

Change in the policy for withdrawing reference standards from sale

EDQM 24/01/2020 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At the present time, a reference standard is withdrawn from the catalogue either on the date that a revised monograph which no longer refers it to becomes applicable, or the date on which a monograph is officially withdrawn from the European Pharmacopoeia.

Read More

New Pharmeuropa website now online

EDQM 24/01/2020 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...

Read More

Council of Europe study highlights inadequacy of legislation on pharmaceutical crime

EDQM 22/01/2020 Strasbourg, France

A recent study, "Medicrime vs Volcano: a practical case study on how the Council of Europe Convention could improve the fight against pharmaceutical crime", carried out within the framework of the Council of Europe MEDICRIME Convention has highlighted shortcomings of current legislative...

Read More

3 new reference standards and 13 replacement batches released in December 2019

EDQM 09/01/2020 Strasbourg, France

New releases: New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales unit Change of EDQM storage/shipping conditions Current non-availability See also: Content of the Ph. Eur. RS catalogue How to place an RS order The EDQM...

Read More

Pharmeuropa 32.1 just released

EDQM 07/01/2020 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...

Read More

Ph. Eur. Supplement 10.2 available now

EDQM 07/01/2020 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. This volume is included in the 2020 subscription (10.0, 10.1 and 10.2) to the 10th Edition of the European Pharmacopoeia. This subscription is available for...

Read More

Ph. Eur. seeks feedback on new general chapter on pyrrolizidine alkaloids

EDQM 19/12/2019 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. Pyrrolizidine alkaloids are nitrogen-containing...

Read More

European Paediatric Formulary online

EDQM 18/12/2019 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...

Read More

Detection of N-nitrosamine impurities: the Ph. Eur. launches a public consultation on the revised general monograph Substances for pharmaceutical use (2034)

EDQM 13/12/2019 Strasbourg, France

The Ph. Eur. Commission proposes to revise the general monograph on Substances for pharmaceutical use (2034). This proposal has been made further to the European Commission referral C(2019)2698 of 2 April 2019 and the review initiated by the European Medicines Agency (EMA) in September 2019 under...

Read More

Outcome of the 165th European Pharmacopoeia Commission

EDQM 11/12/2019 Strasbourg, France

During its 165th session, held in Strasbourg on 26 and 27 November 2019, the European Pharmacopoeia (Ph. Eur.) Commission (re)appointed more than 850 experts to its current 21 groups of experts and 39 active working parties for a new term running from November 2019 to November 2022. The list of...

Read More

Consultation deadline for revised dosage form monographs and general chapters drawing near

EDQM 10/12/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the dosage form monographs and related general chapters. Five different texts finalised by Ph. Eur. Group of Experts 12 have been launched for public consultation in Pharmeuropa 31.4 until 31 December 2019. The general...

Read More

9 new reference standards and 20 replacement batches released in November 2019

EDQM 03/12/2019 Strasbourg, France

New releases New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales unit Change of EDQM storage/shipping conditions Current non-availability Content of the Ph. Eur. RS catalogue How to place an RS order The EDQM announces the...

Read More

EDQM launches a new HelpDesk

EDQM 21/11/2019 Strasbourg, France

As part of its efforts to improve customer service, the EDQM has developed a streamlined version of its HelpDesk and FAQs platform. The new HelpDesk was redesigned on the basis of feedback received from users and now benefits from a more intuitive interface, which is expected to enhance customer...

Read More

Ph. Eur. launches public consultation on general chapter 2.4.20. Determination of elemental impurities

EDQM 14/11/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on general chapter 2.4.20. Determination of elemental impurities. Updated in the context of discussions within the Pharmacopoeial Discussion Group (PDG), the text is intended to become the new harmonised standard for...

Read More

New secondary site of the EDQM to be opened and inaugurated on 15 November 2019

EDQM 14/11/2019 Strasbourg, France

The new secondary site of the EDQM, being opened and inaugurated on 15 November 2019, will enable the safe storage of contingency stocks of European Pharmacopoeia reference standards and ensure their distribution worldwide in the event of major incidents at its main site in Strasbourg. European...

Read More

EDQM 2020 Conference for European Blood Establishments

EDQM 08/11/2019 Strasbourg, France

The year 2020 will mark 10 years of successful collaboration between the EU and the EDQM in the field of blood. On this occasion the EDQM, in collaboration with the European Commission, is organising a conference on the latest challenges faced by European Blood Establishments. This event will...

Read More