Official announcements
messages in brief
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18/07/2019
Please find new and updated FAQ's regarding "Accessible Patient Information Leaflet" at https://www.basg.gv.at/en/medicines/faqs-about-medicinal-products/accessible-patient-information-leaflet/ .
messages in brief
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18/07/2019
The concept of parallel submission in official control authority batch release means that the applicant sends samples to the BASG-OMCL (Official Medicines Control Laboratory) while he is still testing them himself. Complete documentation is not…
messages in brief
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17/07/2019
Manufacturers of an implantable device shall provide information for identification of the device on an implant card in accordance with Article 18 MDR. More detailed guidance on a uniform format of an implant card have now been published on the…
messages in brief
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16/07/2019
For more information on this topic, follow the link to the security features .
Safety warnings
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Blood & Tissue
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08/07/2019
Only available in German
Recall
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Medicines
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03/07/2019
The marketing authorisation holder informed its customers on July 3, 2019 that below mentioned batch of „Elotrace - Infusionszusatz“ show black visible particles.
Safety warnings
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Blood & Tissue
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03/07/2019
Only available in German
Enforcement
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29/05/2019
The product "Artrovex", which is distributed via international online sales platforms and various websites (e.g. www.health-at.live), is classified by the BASG as an illegal presentation medicinal product on the basis of its advertising.
Recall
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Medicines
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14/05/2019
The marketing authorisation holder informed its customers on May 13, 2019 that overweight capsules may be packed and distributed to the market.
messages in brief
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10/05/2019
The authorisation status of allergen products, both for diagnosis and therapy, in the European Union is heterogeneous. In order to facilitate harmonisation throughout the EU, the CMDh Drafting Group on harmonisation of the regulatory approaches for…
