Importation of active ingredients for medicinal products for human use: new regulation
As of 02.07.2013, new regulations apply to the import of active ingredients for medicinal products for human use into the European Union. As of this date, active substances for medicinal products for human use may only be imported if at least one of the following conditions according to Art 46b of the Directive 2012/62/EU is fulfilled:
- The exporting third country is on a list of the Commission according to Art 111b of the Directive 2012/62/EU;
- The competent authority of the exporting third country issues a certificate stating that the establishment is "GMP" compliant;
- The exporting company in the third country has been inspected by a European medicinal products authority and holds a valid GMP certificate;
Those countries which are on the list of the Commission according to Art 11b of the Directive 2012/62/EU are available under the following link . As of 24.06.2013, Switzerland, Australia, Japan and the USA were on this list.
Preparatory measures in Austria
In preparation for the import regulations in this regard and for the evaluation of a possible need for inspection by the Federal Office for Safety in Health Care (BASG), all Austrian manufacturing companies were requested by the BASG to report the purchase of active ingredients for medicinal products for human use from third countries. These reports were compared with those from other EU member states.
The evaluation for Austrian pharmaceutical manufacturers showed that there is currently no need for inspections in third countries. All suppliers of active ingredients for medicinal products for human use from third countries may continue to supply. The prerequisite for the correctness of this assumption is that all Austrian manufacturing facilities have submitted a report to the BASG and that the data are complete.
If you have difficulties with imports due to the regulations coming into force from 02.07.2013 or if your suppliers from third countries are no longer allowed to supply, please contact BASG/AGES Medizinmarktaufsicht at basg@basg.gv.at and inspektionen@ages.at immediately. We will try to find a common solution as soon as possible.
Further information:European Commission
Contact:
Office of the BASG
MMMag. Bernd Unterkofler, MBA
E-mail: basg@basg.gv.at
Institute Inspections, Medical Devices & Hemovigilance
E-mail: inspektionen@ages.at
