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Sotsiaalministeerium · 13. veebruar 2023
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- Mari Amos (Sotsiaalministeerium, Kantsleri vastutusvaldkond, Terviseala asekantsleri vastutusvaldkond, Ravimiosakond)
Sisu (failidest)
Saatja: Mari Amos </o=JM/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=251f698f3cd941a7abdf221f55bce2ea-Mari Amos>
Saaja: 'Grabenstein, Darcy'
Teema: RE: Request for information
Dear Darcy
Thank you for your interest into Estonian system of clinical trials.
Here I send you some links where you can obtain more information:
1. Relevant section of the webpage of Estonian Medicines Agency: https://ravimiamet.ee/ravimid-ja-ohutus/ravimiuuringud/kliinilised-uuringud (googletranslate). If you scroll down you find opening menu where you can obtain specific information about several issues. I.a you can find there special section about reporting etc. Agency can respond to your specific questions if you submit them an email by using address [email protected] <mailto:[email protected]> .
2. All trials are run according to Medicinal Products Act (https://www.riigiteataja.ee/en/eli/515072022009/consolide ). Chapter 5 of the Act regulates both human and veterinary clinical trials more specifically. Sanctions for the non-compliance are listed in § 108 of the act.
3. If you are interested in some statistics I’d refer you to this article postimees.ee/7448080/eestis-kaasati-mullu-ravimiuuringutesse-ligi-4000-patsienti (googletranslate) where you can see some information about volumes and types of trials on 2021.
Good luck with article and would be nice to have a copy of it once it is published.
With best regards
Mari Amos
Advisor | Department of Medicines
| [email protected]
Ministry of Social Affairs
Suur-Ameerika 1 | 10122 Tallinn Estonia
+372 626 9301 | http://www.sm.ee <http://www.sm.ee/et>