Marketing authorisation & life-cycle
Regulatory flexibility during the Corona pandemic
In its March 2020 meeting, the CMDh agreed on flexibility with regard to regulatory deadlines as well as the implementation of user tests for human medicinal products. Further information can be found on the website of the CMDh in the press release of the March Meeting, in the "Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic" recently published by the EC, HMA and EMA, and in an additional document of the CMDh ("Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis").
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Furthermore, the EMA website provides an overview of the measures and EMA's involvement in the global fight against SARS-CoV-2.
For the respective informations for veterinary medicinal products please see the CMDv Website under COVID-19 where also the "Notice to stakeholders: Questions and answers on regulatory expectations for Veterinary Medicinal Products during the Covid-19 pandemic" published by the EC, HMA and EMA and the additional document of the CMDv "Practical guidance of the CMDv for facilitating the handling of processes during the COVID-19 crisis" can be found.
An overview of the measures and EMA's involvement in the global fight against SARS-CoV-2 with regard to veterinary medicinal products can be found here on the EMA website.
Marketing authorisation of medicinal products
Drug authorisation on the basis of the Austrian Drug Law is one of the main tasks of the Federal Office for Safety in Health Care (BASG). During the authorisation process, the experts check the efficacy, safety and quality of the drug. A medicinal product shall only be authorised if the existing risk-benefit profile is proportionate and the benefits outweigh the risks.
An authorisation is initially granted for a period of five years. Afterwards, a new application must be submitted to the BASG, on the basis of which the drug will be re-examined. If the result is positive, the extension takes place. Any changes to medicinal products must also be submitted to the BASG for approval.
There are three marketing authorisation procedures for medicinal products in Europe: