Electronic Submission Ordinance 2011
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 ordinances under Section 81a of the Medicines Act. § Section 81a of the Medicinal Products Act authorizes the Federal Office, in accordance with technical possibilities, to provide by ordinance that, in particular, the applications and notifications provided for under the Medicinal Products Import Act 2010 are to be made in electronic form.
This ordinance does not enter into force with the announcement, but only on 04.07.2011. As of this date, applications and notifications under the Medicinal Products Import Act 2010 must be submitted electronically via the web portal set up for this purpose. This has been available to users for registration and submission on a voluntary basis since May 2, 2011. Further information can be found under the following link: www.basg.at/ages-pharmmed-eservices/
§ Section 6 of the Electronic Submission Regulation 2011 clarifies that this regulation applies to all submissions as of the entry into force of this regulation, even if the transfer of medicinal products or blood products has already taken place before the entry into force of this regulation.
In this context, particular reference may be made to the transitional provision of Section 26(2) AWEG 2010. Until now, according to the current legal situation, shipment notifications had to be submitted no later than six months after the actual shipment. With the entry into force of the Electronic Submission Regulation 2011, this deadline has now been reduced to two months.
Finally, reference may be made to the provision of Section 5 of the Electronic Submission Ordinance 2011, which provides for exceptions from the obligation to file electronically, taking into account hardship cases. The relevant requirements must in any case be made credible to the Federal Office for Safety in Health Care. In such cases, it is permissible to submit applications and notifications in written form and to present the relevant documents.
