Cooperation AGES - Swissmedic On March 15th 2017 Dr. Wirthumer-Hoche (chair of AGES MEA) and the director of Swissmedic, Direktor Schnetzer, have signed a „Memorandum of Understanding“ in Vienna, which is of special strategic importance for both countries. The agreement is seen as formal basis for intensified collaboration and bilateral initiatives – especially in the frames of consolidation of resources and...
Belgium has enacted “the Sunshine Act”, which introduces several substantial changes for medicinal products and medical devices. What is in the Act? The transparency obligation laid down in the Sunshine Act applies to: to marketing authorisation holders for medicinal products for human or veterinary use; to importers, manufacturers and distributors of medicinal products for human or veterinary use; to persons or entities...
After an initial reluctance European authorisation and registration procedures are increasingly used also for (traditional) herbal medicinal products. Austria is a requested reference member state for such procedures and currently number two in the EU-ranking of RMS. With the start of the work of the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA) in 2004 a successful...
In a press release from March 15th, 2017 the Austrian Federal Office for Safety in Health Care informed that the cooperation between Swissmedic and AGES will be intensified. Swissmedic director Jürg H. Schnetzer and Christa Wirthumer-Hoche, director of AGES MEA, signed a Memorandum of Understanding in Vienna, which builds the formal basis for an intensive cooperation and bilateral initiatives. Swissmedic has...
CESP update From 03/04/2017 the submission of electronic documentation, is effective solely through the Common European Submission Portal (Common European Submission Portal, CESP) for human and veterinary medicinal products. The following procedures should be transmitted through CESP: All submissions for Mutual Recognition/Decentralised Procedures (MRP/DCP) national procedures relating to approvals, variations, renewals, PSURs, ASMFs etc., as well as any other documentation should be...
New Head of Department After Esa Heinonen left his position as Head of the Department of Authorisations at Swissmedic in December 2016, Dr. Claus Bolte, former Head of Clinical Review, has been appointed as his successor. Claus Bolte took over his new responsibility on 1st March 2017. For full information, please see the Swissmedic link or contact our CH member for more...
With the upcoming entry into force of the "Cannabis as Medicine" law, a cannabis agency has been established at the BfArM. The cannabis agency will control and regulate the cultivation of cannabis for medical purposes in Germany. Immediately after its establishment, the cannabis agency will start an EU-wide tendering procedure and subsequently award contracts for cultivation to suitable companies. The...
At the conference "Next Generation Pharmacovigilance", held on 18 May 2016 in Zagreb, Agency for Medicinal Products and Medical Devices (HALMED) presented the mobile application for the reporting of suspected adverse drug reactions (ADR reporting). HALMED is among the first three European medicinal product agencies that introduced applications for ADR reporting via smartphones. The mobile application is meant for patients,...
Agency for Medicinal Products and Medical Devices of Croatia (HALMED) had successfully fulfilled all conditions within the evaluation conducted by the Canadian regulatory body Health Canada with the purpose of implementation of the Mutual Recognition Agreement with Canada (EC-Canada MRA) in the area of conformity of good manufacturing practice (GMP) programs. The operational phase of the agreement begins on 1...
Agency for Medicinal Products and Medical Devices of Croatia HALMED) has been officially confirmed as a member of international organisation Pharmaceutical Inspection and Co-operation Scheme (PIC/S). HALMED's membership had been approved by the PIC/S Secretariat in October 2015 and will formally begin on 1 January 2016. This important achievement confirmed once again the exceptional competence of HALMED's employees who enabled HALMED's...