The European Medicines Agency (EMA) or other EU Health Authorities (HAs) might need clarification or additional information to technically review the content submitted to them through various procedures, which would be requested to MAH as day 120/150/180/210 queries.
Marketing Authorization procedure in Europe plays a critical role and allows pharmaceutical companies to legally market and distribute their medicinal products within the European Union. To obtain marketing authorization for their generic products, sponsors must submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
The sunset clause was introduced by the European Medicines Agency (EMA) per Regulation (EC) No. 726/2004, Article 14(4-6), to monitor the marketing status of centrally authorized medicinal products within the European Union (EU) and the European Economic Area (EEA). This leads to the invalidation of the Marketing Authorization (MA) in the following instances:
European manufacturers and Marketing Authorization Holders (MAHs) of medicinal products have various responsibilities. For example, to execute the batch release process and to perform the legal requirements related to Pharmacovigilance, MAHs must identify suitable individuals to perform the roles of Qualified Person (QP) and Qualified Person responsible for Pharmacovigilance (QPPV).
Marketing Authorization Holder (MAH), planning to submit the MAA through any of the Regulatory procedures should check for available dates with the European Medicines Agency (EMA) or with a reference Member State to understand the submission timelines and get confirmation for the submission. The MAH should submit the MAA on the allotted slot to HAs. Delay in the submission should be communicated with HA well in advance.
Registration of the Marketing Authorization Application (MAA) for a generic product with changes in active substance(s), therapeutic indications, strength, route of administration compared to the reference medicinal product is very complex as the MAA relies on pre-clinical and clinical trials data with respect to the reference product and new data.
In accordance with the Article 14(1-3) of Regulation (EC) No 726/2004, any Marketing Authorization (MA), except those granted under exceptional circumstances, is valid until five (5) years from the date of approval. To remain valid and/or to extend the validity, the renewal of the marketing authorization is required before the date of the expiry.
Whether companies are importing medicinal products into the UK from the EU or exporting them from the UK to the EU. knowledge of forthcoming changes is essential as the Brexit transition period comes to an end.
It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.
An Innovative Pharmaceutical Company
This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.
USA-based Pharmaceutical company
The ANDA receipt is received! Thank you very much for your hard work, patience and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. Thank you again and look forward to working with your team on the next project!
Research and Technology based US pharmaceutical company
Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.
US based leading biopharmaceutical company
We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.
A Privately Held Pharmaceutical Research and Development Company
Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.
UK multinational pharmaceutical company
Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.
Canada based, global pharmaceutical company
USA
UK
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INDIA