Let’s finish your UFOs
Any UFOs (=UnFinished Objects) on your desktop? Such as regulatory reports and summaries that you never seem to have time for. Consider our regulatory/medical writing services.
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Any UFOs (=UnFinished Objects) on your desktop? Such as regulatory reports and summaries that you never seem to have time for. Consider our regulatory/medical writing services.
Have you updated your veterinary product information to QRD v. 9 yet?
The EU Veterinary Medicinal Products Regulation (2019/6) entered into force on January 28, 2022, replacing the former directive. The regulation introduced a new version of the QRD template, requiring structural updates to the SmPC, package leaflets and labelling. All existing veterinary products will need to transition to the template before 29 January 2027.
There is still some time left, but the general recommendation is not to wait until the last minute.
Do you need help? Contact us at info@regfile.se.
Are you struggling with IRIS and other regulatory systems?
At RegFile we regularly make scientific and regulatory submissions via IRIS. We can guide and support you through all steps needed for your submission to reach the agency in good shape.
We also offer support with the compilation of background materials, enhanced by subject matter experts and a skilled medical writer.
Both national and central scientific advice are important mechanisms to gain feedback from competent authorities during drug development.
Your choice of adviser is highly dependent on your type of product, the stage of development, your budget and how much time you have at disposal. Today we are sharing a shortlist that might be helpful when planning for EU scientific advice:
National advice from Swedish MPA
– Characterized by openness and dialogue.
– Face-to-face/online meeting or written advice
– Meeting minutes are written by the applicant and reviewed but not formally approved by the MPA.
– Non-binding
– National view
– Quicker (2-4 months)
– Low cost (~€ 6000)
Central advice from EMA (CHMP)
– More bureaucratic procedure
– Preparatory meeting encouragedFormal written advice (issued by the CHMP)
– Non-binding
– Pan-European view
– Slower (4–6 months)
– Expensive (€51,800 to €103,800) but 90% fee reduction for SMEs
Would you like to know more? Contact us at info@regfile.se.
Why can’t I just say that?
Pharmaceuticals aren´t chocolate and when it comes to its promotion, ethics is key.
The pharma industry has a set of ethical rules, complementing the national legislation on marketing. The rules cover a range of areas such as promotional materials, interaction with health care professionals, patient organisation collaboration, transfer of value and more.
At RegFile we support our clients with promotional reviews and guidance for the Nordics, making sure you promote your great product in a balanced and accurate way.
Feel free to reach out: info@regfile.se
To achieve orphan designation, it takes more than just proving your drug is intended to treat a rare disease. Besides prevalence data, in EU you will need to show potential for a significant benefit compared to any existing treatments including non-pharmacological methods such as surgery. So US ODD may be the first step.
Together with our strategic experts within the RegSmart team we will support you with your application for ODD in EU as well as in US. We write, guide, coordinate, and submit, making sure all the regulatory requirements are met.
Interested in ODD? – contact info@regfile.se
