Certification of suitability (CEP) | News | 23 September 2017 | Strasbourg, France
Register today for a free webinar on ‘How to get acceptance of CEP Revisions quickly’. This webinar will outline the process for applying for revisions of CEP application files and give advice on how to obtain their fast acceptance. Learn about the revisions process, the correct classification of changes, and how to prepare and organise the documentation.
Certification of suitability (CEP) / CEP new application | News | 22 September 2017 | Strasbourg, France
The company details (name, address, postal code, plot numbers…) mentioned in the application form for a CEP application (holders, manufacturing sites etc.) are reported on the CEPs. This information must therefore be accurately declared.
Patient & Consumer Protection / Anti-counterfeiting activities | News | 22 September 2017 | Strasbourg, France
On 21 September 2017, Turkey became the eleventh state to ratify the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (CETS No. 211), also known as the MEDICRIME Convention
Certification of suitability (CEP) | News | 22 September 2017 | Strasbourg, France
Following a recent administrative reform in India, new districts and mandals have been created on the State of Telangana. This reorganisation has an impact for CEPs and applications for CEPs (new and revision).
European Pharmacopoeia | News | 21 September 2017 | Strasbourg, France
With a view to improving the correspondence between liquid chromatography column brand names and the reagents used to describe the stationary phases used with these columns, an overall review of all the monographs concerned has been undertaken.
Products and Services | News | 20 September 2017 | Strasbourg, France
The 9.4 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 April 2018.
Reference Standard / Biological reference preparation (BRP) | News | 18 September 2017 | Strasbourg, France
Following the adoption of new human immunoglobulin reference standards, existing sales restrictions have been lifted.
Transplantation / Organ trafficking | News | 15 September 2017 | Strasbourg, France
The Council of Europe Convention against Trafficking in Human Organs was signed by Ukraine on 11 September 2017. In addition, on 12 September 2017 the Convention was ratified by Norway, one of the initial signatory Member States when the Convention first opened for signature in 2015. This brings the total number of signatures to 16 and the ratifications to 3. The Convention will enter into force...
Transplantation / Legal Framework | News | 15 September 2017 | Strasbourg, France
The EDQM has published the 3rd edition of its compendium of all the Council of Europe legal instruments and reports covering ethical, social, scientific and training aspects in the field of donation and transplantation.
Patient & Consumer Protection / Anti-counterfeiting activities | News | 12 September 2017 | Strasbourg, France
On 27 July 2017, Burkina Faso ratified the Council of Europe’s Medicrime Convention. This 10th signatory party to the convention triggers the establishment of the Committee of the Parties – the Convention’s monitoring body – a major step forward in the fight against falsified medicines.
Transplantation / Publications / Transplant Newsletter | News | 11 September 2017 | Strasbourg, France
Volume 22 (September 2017) of Newsletter Transplant is now available as a free PDF download on the EDQM website, or as a free paper copy via the EDQM Store.
Transplantation / Donation Campaigns & European Organ Donation Day (EODD) | News | 06 September 2017 | Strasbourg, France
At the end of 2015, across the 47 member states of the Council of Europe, more than 143 000 patients were waiting for an organ, such as a kidney, liver, heart, lung, pancreas or small bowel
Certification of suitability (CEP) | News | 06 September 2017 | Strasbourg, France
In October, the EDQM will be present at CPhI Worldwide in Frankfurt (Germany). At this yearly gathering of the pharmaceutical industry, the EDQM is looking forward to meeting as many of its clients as possible.
Certification of suitability (CEP) / Procedure of certification (general) | News | 06 September 2017 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Transplantation / Tissue | News | 06 September 2017 | Strasbourg, France
The EDQM has published the 3rd Edition of its guidelines ensuring the quality and safety of tissues and cells for human application, be it for transplantation or clinical use (including insemination and fertilisation).