The variety of medical specialities (2019) and the annual number of submitted clinical trial protocols have steadily increased over the last two decades but the growth has stalled in the recent few years. The government and the industry are constantly working to improve the clinical research environment in Estonia. The number of study centres per protocol, being 1-2 in the early years, has grown as the research has reached out from the tertiary care to the county hospitals and GP-s. Most of the trials are Phase III and II, but also a few pharmacokinetic and bioequivalence studies are carried out each year.
Graph 1. annual number of submitted clinical trial protocols
Graph 2. Medical specialities (2019)
In general terms, approval by one of the two Independent Ethics Committees and informed consent by the study subject, according to the international codes and Declaration of Helsinki, is mandatory. Clinical trial medication should be manufactured according to the GMP (Good Manufacturing Practice) and the trials should be performed and the data generated in compliance with the GCP (Good Clinical Practice) to ensure the ethical and scientific integrity of the trial (GCP code close to the Nordic document by the NLN was mandatory since 1991, later the ICH GCP was adopted and is currently directly referred to by the legislation).
Notification of the clinical trial needs to be submitted to the State Agency using the EudraCT format. A formal letter of ‘no objection’ will be given within 30 days for phase II – IV studies (for phase I studies within 60 days and for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms within 90 days after receipt of the application and required documentation). The time taken by the Agency depends directly on the quality and completeness of the documentation submitted. Please note that together with the notification, a signed declaration by the head of the health-care institution (study centre) has to be submitted.
An activity licence holder (according to the Medicinal Product Act § 18) can import medicinal products intended for clinical trials after the clinical trial has been approved by the State Agency of Medicines.
The State Agency of Medicines shall be duly notified of conveyance of medicinal products from the European Economic Area to Estonia. This notification should be done as soon as possible but no later than on the fifth working day after the consignment has arrived. The notification should include: date of import, information about the consignor and the consignee, information about the investigational medicinal products.
Please send your notifications through the Client Portal.
With regards to import from outside the European Economic Area directly to Estonia:
- The importer (located in Estonia) should have a MIA – manufacturing/importation authorisation (activity licence). MIAs are granted by the State Agency of Medicines. The manufacturing/importing authorisation and the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries should be submitted with request for clinical trial authorisation to the State Agency of Medicines.
- For each consignment to be imported, the importer should obtain a single authorisation for import/permission from State Agency of Medicines. Without this document the medicines cannot pass the necessary Customs’ procedures. Therefore it is important to obtain the single authorisation for import before the consignment arrives.
Please send your applications to: [email protected]
When exporting investigational medicinal products from Estonia to countries within or outside the European Economic Area, notification of export should be sent to the State Agency of Medicines. See details of notification above.
If a medicinal product is listed as a narcotic drug or psychotropic substance in the Annex I of the Regulation No. 73 of the Minister of Social Affairs of 18 May 2005 then it shall be imported and exported under the conditions and pursuant to the procedure provided for in the Medicinal Products Act (RT I 2005, 2, 4; 13, 63; 24, 180) and in legislation established on the basis thereof.
Medicines used in clinical trials and the requirement to verify safety features
According to the European Commission Delegated Regulation (EU) 2016/1612 article 25 section 4c, pharmacies are required to verify and decommission the unique identifier of medicines (whether investigational or auxiliary) with marketing authorisations used in clinical trials. According to the European Commission Guidelines, authorised investigational medicinal product is excluded from the rules on the safety features only if it is known at the time of manufacture that the whole batch is manufactured for use in clinical trials.
What to take into account when supplying investigational products?
The Medicinal Products Act allows both: direct distribution to investigation sites and through a wholsale distributor. The wholesale distributor is not required to verify the authenticity of authorised medicinal products used in clinical trials. Therefore, the sponsor may have various ways to arrange for the verification and decommission of safety features:
- If at the investigational site, the hospital pharmacy is in charge of handling the medicinal products, then the pharmacy is also responsible for the verification and decommissioning of the unique identifier.
- If the auxiliary medicinal products used in clinical trials are bought from a general pharmacy, then this general pharmacy will bear that responsibility.
- If the medicinal products are distributed directly to the investigation site but the investigation site lacks a pharmacy, then it is possible to verify and decommission the unique identifier using The Estonian Medicines Verification Organisation’s (REKS) web-based solution. Further information regarding this option can be found on their website.
Ongoing Clinical Trials
Last updated: 11.11.2022