Certification of suitability (CEP) | News | 12 October 2017 | Strasbourg, France
Supplement 9.4 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 April 2018, and to follow the instructions given in the document.
Certification of suitability (CEP) | News | 11 October 2017 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal...
Certification of suitability (CEP) / CEP new application | News | 10 October 2017 | Strasbourg, France
As of 1 January 2018: eCTD mandatory for new CEP applications and NeeS or eCTD for revision or renewal applications
Products and Services | News | 02 October 2017 | Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
Transplantation / Organ trafficking | News | 28 September 2017 | Strasbourg, France
With the Czech Republic becoming its 4th ratifying party on 21 September, the Convention against Trafficking in Human Organs is getting closer to coming into force. The country is one of the initial signatory Member States to the Convention, when this was first opened for signature in 2015; its ratification was preceded by those of Albania, Norway and the Republic of Moldova.
Certification of suitability (CEP) / Procedure of certification (general) | News | 27 September 2017 | Prague, Czech Republic
The EDQM held a 2-day conference in Prague to exchange with the worldwide pharmaceutical sector and to keep authorities and manufacturers alike informed of recent developments and of the future of its Certification of suitability to the monographs of the European Pharmacopoeia in the global regulatory environment.
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).
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.
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.
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.