Request for barrier-free provision of information for use
The Federal Office for Safety in Health Care (BASG) was obligated within the framework of a conciliation procedure pursuant to Section 14 of the Federal Disability Equality Act (Bundes-Behindertengleichstellungsgesetz) to request the holders of Austrian marketing authorizations, registrations and approvals for parallel imports to make their information for use available in a barrier-free manner.
The conciliation procedure was triggered by the finding that a large number of the directions for use of the medicinal specialties published in the BASG's Register of Medicinal Specialties pursuant to Section 27 of the Austrian Medicines Act were not accessible without barriers.6 Paragraph 5 of the Federal Disability Equality Act stipulates that buildings and other facilities, means of transport, technical commodities, information processing systems and other designed areas of life are barrier-free if they are accessible to and usable by people with disabilities in the generally accepted manner, without any particular difficulty and, in principle, without the assistance of others.
In order to achieve this accessibility, the BASG was obliged during the conciliation procedure to request the holders of Austrian marketing authorizations, registrations and approvals for parallel import to make their information for use available barrier-free in accordance with the PDF-UA standard by December 31, 2020 at the latest.
In order to support the holders of Austrian marketing authorizations, registrations and approvals for parallel import in revising the information for use, if necessary, the BASG plans to provide an accessible adaptation of the "Mutual-recognition, decentralised and referral product-information template" (Version 4), including a guideline on how to prepare information for use in an accessible manner. These templates (for human and veterinary) as well as the guidance document will be made available on the BASG website by Aug. 31, 2018. These documents provided by the BASG are an aid and are to be used on a voluntary basis. Regardless of the use of the documents provided by the BASG, the responsibility for creating an accessible version of the Instructions for Use lies with the holder of the marketing authorization, registration or parallel import permit.
