The proposals are intended to harmonize the pharmacovigilance system provided for in Regulation (EU) No. 1235/2010 and Directive 2010/84/EU. To this end, implementing measures have been developed by the European Commission in the following areas: the content and maintenance of the pharmacovigilance system master file by the marketing authorization…

Orally administered isotretinoin is highly teratogenic and strictly contraindicated in pregnancy. Reliable pregnancy prevention is therefore essential when using isotretinoin (Ciscutan®, various generics). Prescribing, dispensing and taking isotretinoin requires special precautions. More information: uptodate_issue August 2011

With the new DCP-slot alert mailing list applicants have the opportunity to be informed immediately whenever a new version of the availability matrix has been published. In the availability matrix free resources in the different assessor groups for DCPs with AT as RMS are shown. Due to the number of slot-requests and due to short-term cancellations…

On 05.08.2011, the Federal Office for Safety in Health Care sent a draft of the "Regulation of the Federal Office for Safety in Health Care amending the Regulation of the Federal Office for Safety in Health Care on the Fee Tariff pursuant to the GESG - BASG VO No. 01/2011", for review. All interested and affected parties are invited to submit any…

On August 5, 2011, the Federal Office for Safety in Health Care sent a draft of the "Ordinance of the Federal Office for Safety in Health Care on the Collection, Payment and Determination of the Amount of a Medical Device Fee (Medical Device Fee Ordinance 2011)" for review. All interested and affected parties are invited to submit any comments on…

Ketoprofen-containing proprietary medicinal products are approved for the local symptomatic therapy of pain conditions, mainly in the field of traumatology and rheumatology. Due to reports of light-allergic reactions, the risk-benefit balance of these proprietary medicinal products was evaluated on a pan-European level under an Article 107…

The "Standards for the Preparation for Use, the Application and the Disposal of Cytostatic Drugs" are quality standards according to § 2 Z 12 of the Health Care Quality Act (GQG). These standards concern health care facilities and summarize the essential measures to ensure the protection of persons and to guarantee flawless drug quality. The BMG…

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…