The pharmaceutical business sector in Estonia
Investors who want to open a pharmaceutical company in Estonia will mainly focus on the country’s manufacturing capabilities in this business field. Production from pharmaceutical starting material and repackaging of finished dosage forms are two of the most common activities undertaken by pharmaceutical manufacturers in Estonia. Research and development for discovering new active substances and the production of pharmaceutical starting materials are two less exploited business fields.
An Estonian pharmaceutical company
will need to obtain special permits and licenses for functioning. If you are interested in entering this business field, our company registration experts in Estonia
can help you comply with the requirements for inspection, production and marketing of medicinal products
It is very important for this type of company to observe the provisions of the Medicines Authority
. This includes those for marketing authorization and registration, inspection, import control, licensing, quality and market control and advertising and promotion for medicinal products.
Estonian company formation
A pharmaceutical company
is set up just as any other type of company in Estonia
. The investor will need to choose from the available business forms and then observe the process of incorporating and registering the new legal entity with the responsible tax authorities.
The private limited company
is a popular choice among investors but multinational pharmaceutical companies
that want to establish their presence on the Estonian market can also choose to open a branch. Estonia has a transparent and advantageous tax system and the company registration process
Requirements for pharmaceutical manufacturers in Estonia
After the new company is incorporated, the investors will need to make sure that their manufacturing and/or distribution company complies the requirements for licensing. The Good Manufacturing Practices are a set of provisions published by the Government which must be observed by all drug producers in the country. Also, the Good Distribution Practices must be observed by wholesale companies and importers of pharmaceutical products.
Estonia also imposes provisions for the advertising and promotion of medicinal products (different regulations for prescription and non-prescription drugs) and for the authorization and conduction of clinical trials.