German Pharmaceuticals Act (AMG)
The Pharmaceuticals Act of the Federal Republic of Germany stipulates that after the approval of a medicinal product, the experience of its use be continuously and systematically collected and evaluated. According to § 63c AMG, it obliges you, as the holder of a marketing authorisation for a medicinal product intended for human use, to record any suspected case of a serious adverse reaction that has occurred in Germany or abroad and to notify the competent authorities. Notification must take place immediately, but no later than 15 days. § 63b AMG requires you to monitor pharmacovigilance data in order to determine whether there are new risks, changes to existing risks or changes to the benefit-risk balance of pharmaceuticals. Monitoring user reviews and comments of your mobile applications is essential to filter out potential reporting-related content and comply with the legal obligation imposed on you. The App Review Guard is your faithful companion, enabling you to comply with legal requirements.
Medical Devices Safety Plan Ordinance (MPSV)
As a manufacturer of medical devices in the sense of the Medical Devices Act (MPG), you are required to report obligations under the Medical Devices Safety Plan Ordinance (MPSV). Thus in accordance with § 3 of this regulation you are under obligation to report incidents that have occurred in Germany and other member states that are party to the Agreement on the European Economic Area to the competent authorities. In order to be able to reliably identify any occurrences, the monitoring of user comments must also be ensured. App Review Guard will take care of monitoring for you and keep you up to date on any incidents.
The institutions of the European Union have dealt extensively with the topic of pharmacovigilance in recent years and have issued various legal provisions governing the monitoring of reportable events relating to pharmaceuticals.
Article 12 para. 1 of the Commission’s Ordinance (EU) No 520/2012 of June 19, 2012 on the implementation of the provisions of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and the pharmacovigilance tasks provided for by the Council contains the regulation that marketing authorisation holders are required to record all pharmacovigilance information and to ensure that they are handled and stored in such a way as to allow the correct reporting, interpretation and verification of the information. Marketing authorisation holders must also provide mechanisms to ensure the traceability and follow-up of adverse drug reactions.
At the beginning of 2012, the European Medicines Agency (EMA) issued a guideline on good pharmacovigilance practices. For example, in Section VI.B.1 approval holders are encouraged to take appropriate action to collect reports of potential adverse reactions.
In Article 87, the Medical Device Regulation (MDR), which came into force in May 2017 and is mandatory for all member states from May 2020, imposes incident reporting obligations on manufacturers of medical devices, not only for incidents in connection with their products, but also for those arising that have any possible connection with them.
The App Review Guard not only helps you to extract the relevant information from various mobile applications, but also to comply with the documentation requirement. Our software solution allows you to export logs of posts and comments, including the entire message and its time.
Food and Drug Administration (FDA)
The Food and Drug Administration of the United States of America requires the holder of the authorization pursuant to the Code of Federal Regulations Title 21 Sec. 314.80 (b) after approval of a medicinal product, to investigate all adverse reactions reported (from any source, from home and abroad). The US authorities are also aiming for immediate notification and set a maximum deadline of 15 days.
As part of the obligation to report to the US authorities, the App Review Guard is your reliable partner. In this case, you also benefit from the extensive protocol functions for reviews.