Pharmaceutical Drug Registration in Estonia

MOH

Ministry of Health

MOH Website

https://www.emcdda.europa.eu/ 

Regulatory Authority 

Estonia State Agency of Medicines

Regulatory Website 

https://ravimiamet.ee/

Local Authorized Representative Required 

Yes

Classification of Medical Devices

1. Prescription Drugs– Prescription drugs (or legend drugs) are drugs that require a prescription because they are potentially harmful if not used under the supervision of a licensed health care practitioner. Certain prescription drugs have additional controls placed upon them.

2. OTC Drugs- Over the counter (OTC) medicines are drugs you can buy without a prescription.

Drug Registration Process

Clinical Trial

As of January 31, 2022, the Clinical Trials Regulation No. 536/2014 is in effect. All clinical trials of pharmaceuticals intended for human use conducted within the European Union are subject to the new rule. Research that does not include intervention is exempt from the new regulation.

Making the European Union a more desirable location for pharmaceutical research and development is the goal of the new regulation. The rule unifies various procedures pertaining to clinical trial applications for authorization, review, and oversight in the European Union and the European Economic Area.

• The EU Clinical Trials Information System (CTIS) will be used to submit clinical trial applications.
• One trial application = one set of documents.
• The Member States involved will jointly assess the application. Each Member State will decide whether to authorize the study or not.
• The application consists of two parts: Part I (common for all countries) and Part II (country-specific).
• There are clear deadlines for evaluating the application, which are also followed by the ethics committees.
• Simplified notification procedures that do not require sponsors to provide similar information to different authorities in different Member States.
• Clinical trials conducted outside the EU referred to in the application must comply with EU requirements.
• Increased transparency of clinical trials data.
• The Commission will have the right to inspect clinical trials in Member States and in third countries.

Evaluation

As of January 31, 2022, the Clinical Trials Regulation No. 536/2014 is in effect. All clinical trials of pharmaceuticals intended for human use conducted within the European Union are subject to the new rule. Research that does not include intervention is exempt from the new regulation. 

Making the European Union a more desirable location for pharmaceutical research and development is the goal of the new regulation. The rule unifies various procedures pertaining to clinical trial applications for authorization, review, and oversight in the European Union and the European Economic Area.

Initial Application

Clinical trial application is common to all Member States, while Part II is specific to each country. Both clinical first applications and applications for significant modifications (SM) are subject to joint assessment. The Reporting Member State will draft a Part I assessment report as part of a joint assessment, on which the other Member States Concerned may comment and contribute their own thoughts.

Annex I of Regulation No. 536/2014 lays forth the conditions for the application dossier.

The guidelines provided by the European Commission contain the general specifications and templates needed for Part II papers.