Although your product has been approved by the EMA and is now on the market, your work with the Agency is far from over. We are here to help make sure all of the post-authorization requirements are completed in a compliant manner and in accordance with all EMA timelines.
EMA Services: Post-Authorization
You have obtained approval of your product and are ready to begin marketing it in the EU. As you have probably heard, first impressions are everything, so this is a big time for your company and product. Making sure you have an airtight strategy and plan in place and are compliant with all EU and local regulatory legislation updates is critical. Our team of experts has the experience and expertise to help facilitate these activities and make sure you are in the best spot possible when your product finally reaches the market.
Line Extensions (LE) and Variations
Whether it is an LE with completely new formulations or new variations of the same formulation (i.e., new indications, dose level, large CMC variation, etc.), we can help you successfully navigate the process in the following ways:
- Develop regulatory strategy
- Prepare and submit actual submission package(s)
- Act as the primary point of contact with the Health Authority (HA)
Product Information (PI)
Even though your product has already been approved, it is still critical that your Core Data Sheet, a summary of product characteristics (SmPC), patient leaflet (PIL), and labeling stay up-to-date. There are a number of PI requirements that extend well past marketing authorization (MA) and we can help ensure you meet all of them. Specifically, we can assist with:
- Development of Core Data Sheet
- Development of local labels/harmonization text
- Readability testing
- Implement PI changes
From post-authorization safety and efficacy studies and drug utilization studies to educational materials, there are still a number of requirements you must meet after your product obtains MA. We can help make sure you stay on top of all these post-authorization commitments by helping with:
- Protocol and report review
- Review of annual progress reports
- Submission of progress reports and final outcome commitments
Good pharmacovigilance practices (GVP) are a set of rules designed to facilitate the execution of pharmacovigilance within the EU. These rules apply to all MA holders and are enforced by the EMA as well as local regulatory authorities within the EU member states. We can help make sure you are compliant with all applicable GVPs by working with you to develop a risk management plan (RMP) as well as a periodic safety update report (PSUR).
Specifically, we can help in the following ways:
- Update RMP, as necessary
- Track RMP commitments
- Contribute to core PSUR and write region-specific appendices
In the EU, an MA is valid for a period of one to five years depending on the circumstances under which the application was approved. After that, the marketing authorization holder (MAH) may apply for the renewal of the license. We can help you determine when you need to renew your license and can assist throughout the entire process, preparing and submitting the renewal package and responding to questions from the agency as they arise.
After your product has received MA from the EMA and is on the market, there are a number of additional compliance requirements that must be met by the MAH. We can help you navigate the entire post-authorization landscape ensuring that you are compliant with all applicable regulations. We can assist with the following post-authorization compliance activities:
- Control of promotional material versus (inter)national code of conduct
- Data migration
- SOP writing
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