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.

Wholesale licence

A wholesale licence is needed for entitlement to:

  • wholesale distribution of medicinal products, active substances and excipients included in the EC list that are used in manufacturing medicinal products;
  • obtain a permit for parallel import of a medicinal product;
  • bring into Estonia from another EEA state medicinal products not granted marketing authorisation or import from a third country bearer prescription medicinal products.

A wholesale licence is issued according to the procedure set by law. Conditions for issuing a wholesale licence are similar to the conditions for issuing a manufacturing licence as described above.

CLINICAL TRIALS

All clinical trials of pharmaceuticals must be planned, performed, recorded and reported in accordance with Good Clinical Practices. Clinical trials may only be conducted if specific biomedical research has scientific and practical merit, if protection of the interests of the subject and confidentiality of information about the subject have been ensured and if free consent of the subject has been obtained.

Requirements for clinical trials

Clinical trial authorisation is received in parallel by obtaining a permit from SAM and approval (positive opinion) from the Clinical Trial Ethics Committee (CTEC).

Authorisation of a clinical trial requires the following information:

  • trial protocol indicating the objective, design, methodology, statistical criteria and organisation of a trial;
  • other documents and information required by law, including an investigator brochure, an informed consent form, evidence of the investigator's civil liability insurance policy and others.

Issue of permit

CTEC approval and SAM permit are issued within 60 days, and in the case of a clinical trial involving pharmaceuticals for gene therapy or somatic cell therapy, immunological pharmaceuticals or pharmaceuticals containing genetically modified organisms, within 90 days after receiving the application and required documents. CTEC may prolong the term by 90 days.

PROMOTION OF PHARMACEUTICAL PRODUCTS

Advertising and presents

Advertising pharmaceuticals that require a medical prescription to the general public is illegal. When advertising pharmaceuticals to the general public, it must be clear that this is an advertisement and that the product advertised is a pharmaceutical. Advertising to doctors and pharmacists is subject to different rules.

A holder of marketing authorisation must not give presents and services worth more than EUR 6.40 to doctors qualified to prescribe pharmaceuticals, dispensing chemists and pharmacists.

Professional medical training

A holder of marketing authorisation may support participation of doctors and pharmacists in professional events organised by research institutes or trade associations, where they may cover participation fees and other expenses up to a reasonable amount. A holder of marketing authorisation may organise scientific events for doctors and pharmacists, provided that the entertainment programme is not excessive.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.