The European Union directives 2003/94 and 1991/412 on manufacturing of medicinal products are transposed into the national legislation by the regulation of the Minister of Social Affairs „Procedure for Manufacturing of Medicinal Products” (current version available in Estonian; the Procedure is relatively brief, transposing the EU Directives). The regulation gives a further reference to the EU/EEA GMP Guideline (EudraLex Volume 4 in English is directly applicable).
Definition of „manufacturing“ follows the definition in the European Union; it incorporates production processes, sterilisation, packaging, labelling, re-packaging, re-labelling, quality control and batch certification, with related procuring, receipt, storage and dispensing of materials.
Acitivity licence for manufacturing is required for manufacture of all medicinal products, including partial manufacturing (e.g. intermediates), and also for active substances. Import from 3rd countries (outside of the European Union) requires the same type of licence. The national activity licence for manufacturing is equivalent to the manufacturing and importation authorisation (MIA) of the European Union. Activity licences are issued by the State Agency of Medicines.
National registry of activity licences (English version available, please click on the language icon) includes all legal persons that hold an activity licence for manufacturing and/or importation of medicinal products in Estonia (the registry has the English language version, please click on the language symbol (top right hand corner) if necessary).
Scope of activity licences (MIAs) and GMP certificates in the English language can be viewed in the EU common database EudraGMDP.
Pharmaceutical industry in the conventional sense is represented by these companies:
- Cellin Technologies (cell-based advanced therapy product)
- GPE Globalpharma (re-packaging)
- Interchemie Werken De Adelaar Eesti (veterinary medicines: injectables including sterile suspensions, various non-sterile dosage forms)
- Kevelt (sterile products, including injectables and eye products)
- PharmaSynth (non-sterile active substances, small scale)
- Acino Estonia (primary re-packaging)
- Tallinn Pharmaceutical Plant (topical semi-solids, liquids)
- TBD Biodiscovery (non-sterile active substances, small scale; non-sterile intermediate for investigational medicinal product)
- PharmaEstica Manufacturing (effervescent tablets)
The holder of an activity licence for manufacture of medicinal products who wishes to engage in the wholesale distribution of medicinal products which are not manufactured by the holder of the activity licence is required to employ, in addition to the competent person responsible for the manufacture of medicinal products, also a competent person responsible for the wholesale distribution of medicinal products. More information about cross-border movement here.
Distribution
The import, procuring, warehousing, storage, transport and export of medicinal products for the purpose of wholesale distribution or any other manner of wholesale dispensing of medicinal products is considered the wholesale distribution of medicinal products.
Only the holder of an activity licence for wholesale distribution of medicinal products or the holder of an activity licence for manufacture of medicinal products have the right to distribute and dispense medicinal products by way of wholesale. The holder of an activity licence for the manufacturing of medicinal products who wishes to engage in the wholesale distribution of medicinal products which are not manufactured by the holder of the activity licence is required to employ, in addition to the competent person responsible for the manufacture of medicinal products, also a competent person responsible for the wholesale distribution of medicinal products.
You can find all legal persons that have an activity licence for wholesale distribution of medicinal products or an activity licence for the manufacturing of medicinal products in Estonia, in National registry of activity licences. You can find all legal persons that have an activity licence for the wholesale trade in medicinal products or an activity licence for the manufacturing of medicinal products in Estonia, their GDP and GMP Certificates and their contacts in EudraGMDP.
Medicinal products must be distributed and dispensed in any other manner by way of wholesale only to persons who hold an activity licence for provision of pharmacy services, manufacturing of medicinal products or wholesale distribution of medicinal products.
Samples of medicinal products may be dispensed to marketing authorisation holders and investigational medicinal products to persons conducting a clinical trial.
The State Agency of Medicines has the right to authorise holders of an activity licence for wholesale distribution of medicinal products or manufacture of medicinal products to dispense medicinal products free of charge to hospitals and social welfare institutions which, in accordance with legislation, do not have the right to procure medicinal products from wholesalers.
Wholesalers have the right to dispense medicinal gases, full blood and blood components directly to health care providers, whereas medicinal gases may be dispensed directly to the consumer for the purposes of the Consumer Protection Act.
Veterinary medicinal products and medicinal products for human use may be sold wholesale to a veterinarian holding a valid professional activity licence only in the conditions and in accordance with the procedure established under clause 26 (9) 1) of the Medicinal Products Act. A special labelling bearing the words "Ainult veterinaarseks kasutamiseks" [for veterinary use only] must be attached to medicinal products for human use that are dispensed to a veterinarian.
In addition the following persons have the right to make wholesale purchases of medicinal products: social welfare institutions, schools where classes for students with special educational needs as specified in the Basic Schools and Upper Secondary Schools Act have been opened, state authorities, research institutions and owners of ambulance crews entered in the list of persons authorised to make wholesale purchases of medicinal products; this list has been established by a regulation of the minister responsible for the field.
Estonian pharmacies and health care providers are prohibited to purchase medicines from persons who don’t have an Estonian activity licence for wholesale trade in medicinal products. In order to sell medicinal products directly to pharmacies without having a mediator in the form of a holder of an activity licence for wholesale trade in medicinal products; the holder of an activity licence for wholesale distribution of medicinal products should set up a branch or a separate juridical person in Estonia and apply for an activity licence for wholesale trade in medicinal products from the State Agency of Medicines. Having done so, you will be able to import medicines to Estonia and distribute them to pharmacies, including pharmacies of health care institutions, and also to other wholesalers, manufacturers and veterinarians.
Only the following medicinal products can be sold and used in Estonia:
- medicinal products upon which a marketing authorisation has been issued by the State Agency of Medicines or the Commission (hereinafter authorised medicinal products) which are released for dispensing within the European Economic Area;
- medicinal products upon which the State Agency of Medicines has issued a single authorisation for import and marketing.
- Clinical trials of medicinal products must be carried out with medicinal products to which the State Agency of Medicines has granted the corresponding authorisation.
Clinical Trials Regulation to come into effect on 31 January 202203.08.2021
EU Clinical Trials Information System training programmes22.01.2021
Last updated: 10.08.2021
