Based on recent follow-up requests from the Drug Quality and Regulatory Affairs National Procedures Divisions, a list of the most frequently submitted complaints was compiled. In each case, the "Top Five" for new and renewal requests are summarized below. By taking these suggestions to heart, you will increase dossier quality and thus also shorten…

On May 3, 2011, the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications (Electronic Submission Ordinance 2011 - EEVO 2011) was published in the Official Gazette of the Federal Office for Safety in Health Care. The purpose of this ordinance is to make use of the power to issue…

Hip joint endoprostheses are medical devices of the highest risk class (class 3). These medical devices must undergo a development program with clinical studies. If the benefit-risk profile is appropriate, the device is certified by a notified body and may be used as a result. This benefit-risk profile is continuously evaluated within the framework…

Before using the web portal for the first time, registration of the organization is required. In the process, the authorization within the meaning of §§ 4 and 13 AWEG is verified. After successful registration, the applicant receives a user name and password for an administration account. The administrator can create and manage additional users on…

On possible radioactivity

In a letter dated April 29, 2011, the marketing authorization holder informed its customers that the two batches had to be exchanged because routine stability tests had revealed that the test values for active ingredient release and disintegrability were outside the specification.

AGES PharmMed invited to the drug control laboratory

The marketing authorization holder has informed its supplied customers by letter dated April 28, 2011, that a small piece of glass has been detected in a vial of the above mentioned batch. As a precaution, Mallinckrodt/Covidien (NL) is recalling the products of the batch still in circulation from the market.

Baxter Healthcare has identified elevated levels of endotoxin in some batches of the above peritoneal dialysis solutions at its manufacturing facility in Castlebar, Ireland, posing a risk of aseptic peritonitis. Since December 2010, five batches have already been recalled from the market. Since sufficient replacement products are now available, all…

The background to the recent discussions is not a 'new' document from the European Commission, but the 2004 Directive 2004/24 EC, which defines traditional herbal medicinal products and sets the regulatory framework for them across the EU. This innovation brought the opportunity for traditionally proven products to be on the market as medicinal…