Wholesale distribution of medicinal products may only take place between businesses or institutions, without involving patients in the transactions.
The exceptional delivery of a veterinary medicinal product in small quantities from one holder of a professional veterinary activity license to another is not considered wholesale distribution. A small quantity is defined as the amount necessary to immediately ensure the health or welfare of an animal, and it must not exceed the quantity needed for treatment for up to two months. Veterinary medicinal products must be delivered in their original or immediate packaging.
Who needs a Wholesale Distribution Authorization (WDA)?
To start wholesale distribution (all or any of the listed activities above, except transportation) of medicinal products in Estonia, the company must obtain and hold a valid Wholesale Distribution Authorisation (WDA) issued by the Estonian State Agency of Medicines (Ravimiamet). Transportation is considered to be part of wholesale and thus under the responsibility of a WDA holder not transportation service provider. Along with a valid WDA, the company must also comply with good distribution practices, in which case the company will be issued a GDP certificate by the State Agency of Medicines.
A holder of a Manufacturing Authorisation for medicinal products who wishes to wholesale medicines that are not manufactured by them must obtain an additional Wholesale Distribution Authorization. This additional licence is not required if they only distribute medicinal products of their own production.
Who can distribute medicines wholesale?
Only holders of a Wholesale Distribution Authorization or a Manufacturing Authorization have the right to distribute and dispense medicinal products by way of wholesale to pharmacies—including those of healthcare institutions—as well as to other wholesalers, manufacturers, and veterinarians. Additionally there is a nationally established list of institutions that have been granted the right to purchase medicinal preparations in bulk.
Competent Person Requirements and Responsibilities
The holder of WDA must designate a competent person within the company. The competent person responsible for the wholesale distribution of medicinal products must hold an academic degree in pharmacy from a university or possess an equivalent foreign qualification. The competent person must have permanent residence in Estonia and be familiar with Estonian legislation. To properly understand the legislation, the competent person should have a good command of the Estonian language.
Requirements for the Place of Business
The place of business must be accessible at all times in case of emergencies. This means that the activity site must be a physical location directly connected to your wholesale operations. The State Agency of Medicines will conduct inspections within the scope of the authorization and the GDP certificate to ensure compliance with applicable regulations. Therefore, virtual offices or similar arrangements are not acceptable. If you intend to enter into a warehouse partnership agreement, the partner must be another holder of a WDA with the right to store medicinal products and must also be located within the Republic of Estonia.
- You can find all legal persons holding an activity license for wholesale distribution or manufacture of medicinal products in Estonia in the National Registry of Activity Licenses Activity license search.
- Wholesale distribution authorizations are typically issued without an expiration date and follow the standard format established by the European Union. The authorization specifies the activities the wholesaler is permitted to carry out and the types of medicinal products that may be distributed. The responsible person is listed on the authorization and must personally fulfil their duties and be available at all times.
- Additionally, information about license holders, their Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) certificates, as well as their contact details, are available both in the EudraGMDP database Eudra GMP - Public Layout and the Estonian State Agency of Medicines' activity license register.
- Wholesalers must comply with Good Distribution Practice (GDP) guidelines, as well as EU and national legislation.
- The State Agency of Medicines inspects wholesalers to ensure compliance with GDP and relevant legislation, both before granting authorization and routinely thereafter.
- The GDP certificate is generally for five years.
- Once authorized, wholesalers must submit an application for amendments to their activity license to the State Agency of Medicines at least 30 days before the changes take effect. It should also be noted that all license changes are assessed during a Commission that meets once a month, the assessment of the submitted change may take up to 60 days.
Distribution and Dispensing of Medicinal Products
- Medicinal products must only be distributed and dispensed by way of wholesale to persons holding an activity license for provision of pharmacy services, manufacture of medicinal products, or wholesale distribution of medicinal products. Additionally there is a nationally established list of institutions that have been granted the right to purchase medicinal preparations in bulk.
- Samples of medicinal products may be dispensed to marketing authorization holders, and investigational medicinal products may be dispensed to persons conducting clinical trials.
- The State Agency of Medicines may authorize license holders to dispense medicinal products free of charge to hospitals and social welfare institutions that are not entitled to procure medicines from wholesalers under legislation.
- Wholesalers may dispense medicinal gases, full blood, and blood components directly to healthcare providers. Medicinal gases may also be dispensed directly to consumers for purposes defined in the Consumer Protection Act.
- Veterinary medicinal products and medicines for human use may be sold wholesale to veterinarians holding a valid professional activity license only under conditions set out in § 26(9) of the Medicinal Products Act.
- Medicinal products for human use dispensed to veterinarians must carry a special label stating “Ainult veterinaarseks kasutamiseks” (For veterinary use only).
Only the following medicinal products may be sold and used in Estonia:
- Medicinal products with marketing authorization issued by the State Agency of Medicines or the European Commission, authorized for dispensing within the European Economic Area;
- Medicinal products with a single authorization for import and marketing issued by the State Agency of Medicines.
- Clinical trials must be conducted using medicinal products authorized by the State Agency of Medicines.
Good Distribution Practice (GDP) inspections
A Good Distribution Practice (GDP) inspection is an inspection of a wholesale distribution site for medicines or active substances to ensure compliance with the principles of GDP. The State Agency of Medicines inspects wholesalers of medicines or active substance distributor site for compliance with GDP. If a company is not in compliance with GDP, a deficiency will be cited.
- An initial GDP inspection as part of a new application for a Wholesale Distribution Authorization (WDA) or Registration of an Active Pharmaceutical Ingredient (API).
- Routine GDP inspections occur on an ongoing basis to ensure continuous compliance with EU GDP guidelines after a WDA or API is granted.
- Non-routine inspections in relation to an application by the company to make changes to activities.
- Non-routine inspections may be carried out as targeted inspections to investigate non-compliance issues that pose a risk to adherence to EU GDP guidelines and/or public health (for-cause inspections).
- The inspections are conducted by the State Agency of Medicines at intervals not exceeding five years (meaning minimally once in 5 years). However, the inspection frequency may be adjusted on an ad hoc basis based on risk assessment and/or specific needs.
Last updated: 10.12.2025
