Maas & Peither, GMP-Publishing

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The EMA (European Medicines Agency) and the European Commission have published an updated version of the Q&A document which is intended to help the pharmaceutical industry to organise the UK’s withdrawal from the EU for their company.
The document now includes additional information on marketing applications and authorisations for different types...

On 24 November 2017, the European Medicines Agency has published a practical guidance document on post-Brexit Changes. The Practical Guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure comes in the form of nine questions and answers and outlines the...

On 24 November 2017, the European Commission has published the final version of the Guidelines on GMP specific to Advanced Therapy Medicinal Products. The term “Advanced Therapy Medicinal Products” (ATMPs) is used to designate gene therapies, somatic cell therapies and tissue engineered products.
According to the European Commission, the 90-page...

According to the Swiss Federal Office of Public Health FOPH, Switzerland is revising its medical devices legislation, closely modelled on the various new EU requirements aiming at an improvement on the safety and quality of medical devices.
The medical devices regulation in Switzerland goes back to January 2002. Since then it has been continuously...

The city to host the new headquarter of the European Medicines Agency EMA is chosen. Amsterdam emerged as the winner ahead of Milan and Copenhagen, the two other cities that reached the second and final round.
27 EU Member States took the decision on where to move the EMA which employs over 900 people. The final winner Amsterdam was drawn by lot...

In July 2017 the German Federal Ministry of Health (BMG) entered into a sponsoring contract with Maas & Peither GMP Publishing. From now on, the BMG will involve GMP Publishing in the official translation of the EU GMP Guide and its annexes.
In this cooperation, we shall provide the BMG with German translations of the documents and we shall be...

A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities: “Elemental impurities: If purified water in bulk does not meet the requirement for conductivity prescribed for Water for injections (0169) in bulk, a risk assessment according to general chapter 5.20...

The German Federal Ministry of Health “Bundesministerium für Gesundheit, BMG” has published the official German translation of Annex 16: Certification by a Qualified Person and Batch Release, which is part of the EU GMP Eudralex Volume 4 GMP guidelines.
The document is now available on the website of the BMG.
If you are interested in the German...

As of 1 November 2017, the Mutual Recognition Agreement (MRA) between the European Union and the United States enters the operational phase. The MRA, which will allow to recognise inspections of manufacturing sites for human medicines conducted in each partners’ respective territories shall update the agreement dating back to 1998. The proceedings...

On 16 October 2017, the EMA (European Medicines Agency) has published its 17-page Business Preparedness Plan to ensure continuity of the Agency’s operations once the United Kingdom is no longer a member country of the European Union. The plan identifies three main priorities: Not to jeopardise EMA’s positioning in the pharmaceutical arena in the...