Legal & Regulatory > Estonia > Marketing, Manufacturing, Packaging & Labeling, Advertising

All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

A. MEDICINES (new medicines, biologics, OTC medicines)

There are the following ways to obtain marketing authorization for a medicinal product:

• The national procedure (application is submitted to the State Agency of Medicines);
• The centralized procedure (application is submitted to the European Medicines Agency);
• The decentralized procedure and the procedure of mutual recognition (application is submitted to a medicines agency of another member state of the EU).

Below, only Estonian national procedure is described. To apply for a marketing authorization in Estonia (through national procedure), corresponding application together with supplementary documentation to the State Agency of Medicines shall be submitted and applicable fees shall be paid.

The types of application for marketing authorizations are the following:

1) Independent application:

• the application based on original research;
• the application based on published literature, i.e. bibliographic application;
• the application for a medicinal product that contains a fixed combination of recognised active substances which have not been used in combination for therapeutic purposes;
• the application including informed consent.

2) Generic application (please see next question for details).

The submission of the applications for a marketing authorization is quite easy in Estonia, as all applications and documents can be submitted electronically (there is no need for paper copies) and there are no country-specific requirements for supplementary documentation.

An applicant wishing to obtain a marketing authorization must, by scientific methods, prove that the medicinal product, if used for its intended purpose, is safe and effective according to the requirements of modern medical science, that the quality of the medicinal product complies with the requirements provided by Medicinal Products Act and its regulations.

The State Agency of Medicines grants an applicant a marketing authorization in respect of a medicinal product or informs the applicant of refusal to grant a marketing authorization within 210 days as of the date of acceptance of the application.

B. MEDICAL DEVICES

Basic requirements for placing the medical device on the market and putting it into service, are the following:

• the device meets the requirements of applicable legislation;
• clinical evaluation has been provided for the device, and where necessary, a clinical investigation of the device has been conducted;
• conformity assessment of the device has been carried out;
• the device is accompanied by conforming information necessary for identification of the manufacturer and for the safe use of the device for its intended purpose.

To market a medical device, marketing authorization is not required, but at least 10 days before the medical device is placed on the market, the Health Board must be notified thereof.

2. What is the authorization process for the marketing of generic versions of these products?

For generic versions of medicinal products, generic application together with supplementary documentation to the State Agency of Medicines shall be submitted and applicable fees shall be paid. The applicant must prove that that the medicinal product is similar (with the same quantitative and qualitative composition of active substances and the same pharmaceutical form) and bioequivalent to a medicinal product in respect of which a marketing authorization was granted in Estonia or another Member State of the European Economic Area at least eight years ago.

The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy. The various immediate-release oral pharmaceutical forms are considered to be one and the same pharmaceutical form.

The State Agency of Medicines grants an applicant a marketing authorization in respect of a medicinal product or informs the applicant of refusal to grant a marketing authorization within 210 days as of the date of acceptance of the application.

3. What are the typical fees for marketing approval?

A. MEDICINES

Fees for the review of application for issue of a marketing authorization of a medicinal product are the following:

• state fee is EUR 32;
• fee for professional assessment of the application is up to EUR 1,275 (for generics EUR 958);
• additional fee is EUR 14,000 (initial decentralized marketing authorization procedure or marketing authorization procedure of mutual recognition where the reference country is Estonia).

State fee for the review of an application for clinical trial of a medicinal product is EUR 385.

B. MEDICAL DEVICES

As specific authorization for manufacture of medical devices and marketing authorization of a medical device is not required, specific state fees do not apply.

4. What is the period of authorization and the renewal process?

The State Agency of Medicines grants an applicant a marketing authorization in respect of a medicinal product or informs the applicant of refusal to grant a marketing authorization within 210 days as of the date of acceptance of the application.

For the renewal of the marketing authorization, a marketing authorization holder must submit an application together with supplementary documentation to the State Agency of Medicines at least 9 months before the expiry of the authorization. The State Agency of Medicines renews a marketing authorization or informs the holder of a marketing authorization of the refusal to renew the marketing authorization before expiry of the marketing authorization. The State Agency of Medicines may extend the term of validity of a marketing authorization until an application for renewal of the marketing authorization has been processed, but not for more than one year.

5. What are the requirements, if any, for post-approval pharmacovigilance?

A. MEDICINES

In respect of pharmacovigilance, the pharmacovigilance system is used by the State Agency of Medicines and marketing authorization holders. The system is enacted by the Medicinal Products Act and is designed to monitor the safety of authorised medicinal products and detect changes to their risk-benefit balance.

Obligations of the marketing authorization holder include inter alia: establishment of a pharmacovigilance system with regard to authorised medicinal products and ensuring that entries are made in the pharmacovigilance system master file of the pharmacovigilance system with regard to its implementation, appointment of a qualified person responsible for pharmacovigilance, registering and recording of information about adverse reactions, implementing the risk management system with regard to each medicinal product, communication of safety information to the State Agency of Medicines, etc.

Obligations of the State Agency of Medicines include inter alia: recording information about adverse reactions in a web environment and on paper and taking appropriate measures to obtain accurate and verifiable data about adverse reactions, collection and assessment of pharmacovigilance data to determine whether there are new risks, whether risks have changed or whether there are changes to the risk-benefit balance of a medicinal product, taking the appropriate measures for prevention and reduction of risks relating to pharmacovigilance, inspection of the functionality of the pharmacovigilance systems of marketing authorization holders, etc.

Physicians, dentists, veterinarians, nurses, midwifes are also required to inform the State Agency of Medicines of an adverse reaction of a medicinal product. Users of medicinal products have the possibility to inform the State Agency of Medicines of an adverse reaction. If necessary, the pharmacists assist the user of the medicinal product in completing the report on an adverse reaction to a medicinal product and in submitting it to the State Agency of Medicines.

After granting a marketing authorization, the State Agency of Medicines may obligate the holder of the marketing authorization to carry out a safety survey if there are doubts about the safety of the medicinal product or an efficacy survey if there are doubts about the adequacy of previous efficacy studies.

The frequency of submission of periodic safety update reports is specified in the conditions of the marketing authorization.

Safety of a medicinal product can also be evaluated through post-authorization non-interventional safety study, initiated by the marketing authorization holder on its own initiative or for the purpose of fulfilment of the conditions of the marketing authorization.

B. MEDICAL DEVICES

In respect of safety and adverse incidents, manufacturers, distributors and healthcare providers are required to share information with and report adverse events to Health Board. For example, the manufacturer of a medical device shall inform the Health Board of any important changes in the device, of any malfunction or deterioration in the characteristics or performance of a medical device and technical reasons thereof, as well as of any inadequacy in the labelling or instructions.

6. Are foreign marketing authorizations recognized?

For distribution of a medicinal product in Estonia, a marketing authorization valid in Estonia is required, foreign marketing authorizations are not recognized.

Within the European Economic Area, decentralized marketing authorization procedure or marketing authorization procedure of mutual recognition are possible in addition to national marketing authorization procedure.

7. Are parallel imports of medicines or devices allowed?

Parallel import of medicines requires license for parallel import, which is granted if all the following requirements are met:

• license for parallel import is applied for in respect of a medicinal product which by its clinical effect is identical to a medicinal product imported into Estonia by an undertaking appointed by the marketing authorization holder;
• the medicinal product concerning which the application is submitted is imported into Estonia from a Member State of the European Economic Area;
• a marketing authorization valid in a Member State of the European Economic Area has been granted in respect of the medicinal product concerning which the application is submitted;
• the same person holds the marketing authorization in Estonia and another Member State of the European Economic Area, or belongs to the same group of manufacturers of medicinal products.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners? 

A. MEDICINES (Legal Restrictions)

Healthcare organizations. A holder of a marketing authorization has the right to support a medical or pharmaceutical event organised by a research institution or professional organisation, provided that a contract is concluded between the marketing authorization holder and the organiser of the event, precluding any influence over the program.

Healthcare Professionals (HCPs):

• Holders of marketing authorizations are prohibited to give gifts and provide services the value of which exceeds EUR 6.40 to persons qualified to prescribe medicinal products, pharmacists and assistant pharmacists, and such persons are prohibited from accepting such gifts or services from marketing authorization holders or their representatives. Receipt of all pecuniary gifts is prohibited.
• Gifts must be relevant to the corresponding professional practice of the persons and must not be connected to the sale or prescription of specific medicinal products or medicinal products manufactured by a specific manufacturer.
• Provision of pecuniary gifts and gifts the value of which exceeds the limit of EUR 6.40 (support) is only permitted in events where such support is provided for participation in medical or pharmaceutical events organised by a research institution or professional organisation.
• Such support must be granted exclusively under conditions which must be made public and which must not be connected to the sale or prescription of specific medicinal products or medicinal products manufactured by a specific manufacturer, and the parties are required to enter into a written contract to such effect, precluding any inducement of the sale or prescription of medicinal products.
• Holders of marketing authorizations have the right to support participation in medical or pharmaceutical events by compensating for the fee for participating in the scientific part of the event and, to a reasonable extent, also for accommodation and transport costs.
• If a holder of a marketing authorization organises a scientific event intended for persons qualified to prescribe medicinal products, pharmacists or assistant pharmacists, hospitality offered at such events, including entertainment, must remain within reasonable limits, be strictly limited to the main scientific objective of the event and must not be extended to persons other than those mentioned above.

B. MEDICINES (Industry Standard)

If a marketing authorization holder is a member to the Association of Pharmaceutical Manufacturers in Estonia (APME), Ethical Code of APME is applicable (the Ethical Code is based on the EFPIA’s code on the Promotion of Prescription-Only Medicines to, and Interaction with, Healthcare Professionals, adopted by the EFPIA Board on 5 October 2007).

C. MEDICAL DEVICES

There are no specific requirements and restrictions on marketing practices of medical devices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners.

The legislation for the general requirements of advertisement is the Advertising Act. It should also be noted that in Estonia, corruption (giving and accepting of bribe) in private sector is criminalized as well.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

A. MEDICINES

The primary legislation for the manufacturing approval and manufacture is the Medicinal Products Act and its regulations. Requirements for manufacture of medicinal products include requirements applicable to facilities, installations, technical equipment, staff and work organization, documentation and quality control.

The authority with jurisdiction over manufacture of medicines is the State Agency of Medicines.

B. MEDICAL DEVICES

Manufacture of medical devices does not require a specific authorization. The primary legislation for the manufacture of medical devices is the Medical Devices Act and its regulations.

Requirements for manufacture of medical devices include requirements applicable for design, production and packaging of medical devices, in more specific: requirements for the chemical, physical and biological features, requirements for the environmental conditions of manufacture, requirements for radiation protection, etc.

The authority with jurisdiction over manufacture of medical devices is the Health Board.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

According to the Medicinal Products Act, the manufacturing of medicinal products and active substances must comply with the good manufacturing practice of the European Economic Area.

11. What is the inspection regime for manufacturing facilities?

A. MEDICINES

The State Agency of Medicines exercises state and administrative supervision over the performance of Medicinal Products Act and legislation established on the basis thereof. SAM is empowered to enter into premises and facilities, to examine premises and facilities, to take movables into storage, to take samples of products and substances, to question and summon persons, to require presentation of documents, etc., to monitor and evaluate compliance with applicable legislation.

B. MEDICAL DEVICES

The Health Board exercises state and administrative supervision over the performance of Medical Devices Act and legislation established on the basis thereof. The Health Board is empowered to enter into premises and facilities, to examine premises and facilities, to take movables into storage, to take samples of products, to question and summon persons, to require presentation of documents, etc., to monitor and evaluate compliance with applicable legislation.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

State and administrative supervision over the performance of Medicinal Products Act and its regulations is exercised by the State Agency of Medicines and, according to their competence, by the Health Board, the Veterinary and Food Board, Competition Authority and the Tax and Customs Board. Foreign inspectors are not empowered to exercise supervision in Estonia.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Medicinal products must be transported and stored in a manner that ensures the preservation of their quality and prevents them from falling into the hands of unauthorised persons or becoming a hazard to humans, animals or the environment.

Medicinal products must be distributed and dispensed in packaging in Estonian language and must be accompanied by information in Estonian concerning the composition, content of active substances, and requirements for the use and storage of the medicinal product.

The design of packaging must not be misleading with regard to its composition or general effects and must ensure the distinguishability of the product from other medicinal products.

Handling of medicinal products (manufacture, wholesale, pharmacy services) requires a corresponding activity license. Holders of the activity license must implement work procedure rules for handling of medicinal products, document and audit handling of medicinal products.

14. What information must be included in medicine and device labelling?

A. MEDICINES

Medicinal products must be distributed and dispensed in packaging in Estonian language and must be accompanied by information in Estonian concerning the composition, content of active substances, and requirements for the use and storage of the medicinal product. Package leaflet shall include the following information:

• the name of the medicinal product;
• active substances;
• the pharmaceutical form;
• the pharmaco-therapeutic group;
• the name and address of the holder of the marketing authorization and of the manufacturer;
• the therapeutic indications;
• contra-indications;
• appropriate precautions for use;
• forms of interaction with other medicinal products and other forms of interactions;
• special warnings;
• the dosage;
• the method and, if necessary, route of administration;
• the frequency of administration
• the duration of treatment, where it should be limited;
• the action to be taken in the case of an overdose (e.g., symptoms, emergency procedures);
• the course of action to take when one or more doses have not been taken;
• indication, if necessary, of the risk of withdrawal effects;
• a description of the undesirable effects which can occur under normal use of the medicinal product;
• a reference to the expiry date indicated on the label;
• the date on which the package leaflet was last revised.

B. MEDICAL DEVICES

Every medical device must be accompanied with information which includes identification information of its manufacturer and ensures safe usage of the device taking into account educational and knowledge level of its potential user. General requirements for the labelling of a medical device are the following:

• Information necessary for safe and purposeful usage of the medical device must be recorded on the device, on the package or on both or on the sales packaging;
• To every package, instruction for usage must be added;
• If necessary, the information must be provided in badges/symbols as well.

More detailed requirements are enacted by the Medical Devices Act and its regulations.

15. What additional information may be included in labelling and packaging?

Only information enacted by the Medicinal Products Act and its regulations may be included in labelling. The outer packaging or the package leaflet may include symbols or pictograms designed to clarify the information provided as well as other information consistent with the summary of the product characteristics, except for elements of promotional nature.

16. What items may not be included in labelling and packaging?

Information and items not foreseen by the Medicinal Products Act and its regulations may not be included in labelling. Information not consistent with the summary of the products characteristics and elements of promotional nature may not be included in labelling and packaging.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

A. MEDICINES

Advertising of medicinal products is regulated by the Advertising Act and Medicinal Products Act.

Advertising of prescription medicines to the general public is prohibited. Only medicinal products concerning which a marketing authorization is valid in Estonia may be advertised and only the marketing authorization holder has the right to advertise the medicinal product or order the advertising of such product. Other general requirements for advertising of medicinal products are the following:

• The advertising of a medicinal product must meet the general requirements provided for in the Advertising Act and be in full compliance with the information specified in the summary of product characteristics of the medicinal product;
• The advertising of a medicinal product must facilitate rational use of the medicinal product by presenting information in an objective and unexaggerated way. The advertising must not be misleading and must not exaggerate the properties of the medicinal product;
• Each time the name of the medicinal product is mentioned, it must be accompanied by the name of its active substance set out in a clearly distinguishable and legible form;
• include the text “Attention! This is a medicinal product. Before using the product, carefully read the information leaflet contained in the packaging. Consult a doctor or pharmacist if complaints persist or adverse reactions occur.” etc.;

It is prohibited to supply samples of medicinal products to persons not qualified to prescribe medicinal products, and, for promotional purposes, to sell or give away items connected to medicinal products or to organise raffles or lotteries related to medicinal products for such persons, and to offer such persons other medicinal products, goods or services free of charge or at a discount rate in connection with the purchase of a medicinal product.

Advertising of prescription only medicines and provision of samples may only be addressed to persons qualified to prescribe them, pharmacists and assistant pharmacists.

B. MEDICAL DEVICES

There are no specific requirements and restrictions on marketing and advertising of medical devices. Primary legislation for the general requirements of advertisement is the Advertising Act. According to Advertising Act, an advertising shall not, inter alia: provide inaccurate information, suggest that the information presented has a scientific basis if it actually has not, claim or suggest that the goods or services have special features if such features are characteristic to all similar goods or services of the same type, refer to properties of the goods or services which cure, treat, mitigate or prevent diseases, malfunctioning or malformations, except in the cases provided by law, etc.

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicines can be sold and delivered from pharmacies only.

There are no specific restrictions for sale and delivery of medical devices. Medical devices can be sold and delivered via post.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

Restrictions and requirements are the same for all channels of advertising. Advertising of medicinal products must comply with restrictions and requirements described in question No. 17. For some channels, for example for advertising in TV, radio, etc., specific restrictions and requirements are applicable.

20. May medicines and devices be advertised or sold directly to consumers?

Advertising of prescription only medicines to the general public is prohibited. Advertising of other medicinal products and medical devices to the general public and directly to consumers is allowed. Medicines and medical devices may be sold directly to consumers (medicines may only be sold by pharmacies, prescription only medicines may be sold only based on the corresponding prescription).

21. How is compliance monitored?

The State Agency of Medicines constantly monitors advertising activities of market authorization holders. Advertising of medicines is monitored also by the Association of Pharmaceutical Manufacturers in Estonia. Under the ethics code of APME, support provided to HCPs must be published on the website of the provider.

22. What are the potential penalties for noncompliance?

The penalty for violation of the requirements for advertising of medicinal products committed by a legal person is a fine of up to EUR 32,000.