Manufacture

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.