Manufacturing Of Pharmaceutical Products - Estonia

Pharmaceutical products may be manufactured only by a legal entity that holds a manufacturing licence (Licence) issued by the Estonian State Agency of Medicines (SAM). The Licence authorises the entire or partial production of pharmaceuticals and (or) a variety of processes related to packaging, labelling, etc. Pharmaceutical products must be manufactured in compliance with Good Manufacturing Practice standards. The Licence grants the right to distribute pharmaceutical products manufactured by the Licence holder and imports of these from third countries.

Requirements for obtaining a licence

A legal entity seeking to obtain a Licence must:

specify the pharmaceutical forms, the location where they will be manufactured and (or) controlled as well as a description and scheme of manufacturing processes; have at its disposal sufficient and appropriate premises, technical equipment and control facilities complying with the requirements established by law; enter into a contract with a person for fulfilling the duties of a qualified person responsible for manufacture and (or) import and comply with other requirements established by law. Issue of licence

SAM decides to issue (or refuse to issue) a Licence within 60 days from receiving the application. The Licence is issued for up to 5 years.

ENTERING THE MARKET

Medicinal products manufactured industrially or involving an industrial process may be supplied to the Estonian market only if registered in the Register of Activity Licences for Handling of Pharmaceuticals. Marketing authorisation for pharmaceuticals is issued by SAM. The European Commission (EC) grants marketing authorisations covering all European Union Member States.

Requirements for marketing authorisation

A person seeking marketing authorisation must:

apply together with the documents and information required by law; and provide results of pharmaceutical (physico-chemical, biological or microbiological), pre-clinical (toxicological and pharmacological) and clinical trials; or prove that the medicinal product is a generic medicinal product of a reference medicinal product which is or has been authorised for not less than 8 years in a European Economic Area (EEA) state or in the Community. Issuing marketing authorisation

SAM decides to issue (or refuse to issue) marketing authorisation within 210 days from receiving the application. Marketing authorisation is granted for 5 years and may be renewed for an indefinite period.

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