Can I import an FDA-approved drug into Estonia for resale, and what FDA and EU regulatory steps do I need to follow?

Question

I'm based in Estonia and want to import a drug that's FDA-approved for sale in the US into the EU market. I need to know if FDA approval alone is enough or if EU/EEA authorization, labeling, and pharmacovigilance requirements apply. What licenses or registrations would I need, and what timelines and costs might be involved?

Sadekov Law Firm · Accepted Answer

If you require assistance with this matter, you may either file the relevant application directly with the Estonian State Agency of Medicines (Ravimiamet) or appoint our firm to handle the procedure on your behalf. We work on an hourly fee basis and can support you with all procedural steps you consider necessary.

Can I import an FDA-approved drug into Estonia for resale, and what FDA and EU regulatory steps do I need to follow?

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