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

AGES PharmMed invited to the drug control laboratory

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…

Prevenar (active ingredient: pneumococcal polysaccharides of serotype 4, 6B, 9V, 14, 18C, 19F and 23F, conjugated to CRM197 carrier protein, adsorbed) has been licensed since 2001 under the centralized procedure in all EU member states for children aged two months to five years. This pneumococcal vaccine protects against meningitis (meningitis),…

[Translate to english:] EudraCT - Umstellung auf Version 8

AGES PharmMed is receiving a high number of requests to act as Reference Member State for the Mutual Recognition and Decentralised Procedure. The routine of allocating time slots for DC procedures allows better scheduling of applications and optimising the use of the assessor resources. We will accept to act as RMS for as many submissions as…

At the end of 2010, the following deadlines will expire according to the Medicines Act BGBl Nr 185/1983 as amended: Inclusion of doping warning until 31.12.2010 All medicinal products concerned must contain the doping warning by 31.12.2010 (according to § 94g AMG). This is done as a change according to § 24 paragraph 6 AMG; subject to notification.…

As of 01.12.2010, the agreement between the Republic of Austria and the Government of the Principality of Liechtenstein concerning the automatic recognition in Liechtenstein of human and veterinary medicinal products authorized or registered in Austria enters into force. It regulates the procedure of recognition, technical cooperation as well as…

Table 1: Product on the market and new application filed (65)*. Table 2: Product not on the market, new application filed (6)** Table 3: Product on the market, no new application filed (122)* Table 4: Product not on the market, no new application filed (551)** * Updated 02.05.2011 ** Updated on 03.05.2011 Queries: Univ.-Doz. Dr. Reinhard Länger…