Application for an activity licence for pharmacy services

You need to apply for an activity licence for pharmacy services, if you wish to operate in the field of retail distribution of medicinal products. Pharmacies are divided into the following categories based on the contents of the service:

  • a general pharmacy, which provides the service of wholesale distribution of medicinal products for human use and veterinary medicinal products;
  • a hospital pharmacy, which supplies medicinal products for a hospital or a state authority;
  • a veterinary pharmacy, which sells veterinary medicinal products.

An activity licence is issued by the State Agency of Medicines.

The provision of pharmacy services is regulated by:

  • General Part of the Economic Activities Code Act;
  • Medicinal Products Act;
  • Act on Narcotic Drugs and Psychotropic Substances and Precursors thereof;
  • Regulations of the Minister of Social Affairs:
  • “Health protection requirements for pharmacies and their structural units”;
  • “The conditions and procedure for the transportation and storage of medicinal products”;
  • “The procedure for collection of unusable medicinal products from consumers at a general pharmacy and veterinary pharmacy and forwarding for destruction thereof”;
  • ”Conditions and procedure for the preparation, divide-up and inspection of medicinal products in pharmacies and the list of medicinal products prepared as officinal formulae”;
  • ”A list of herbal substances, and the conditions and procedure for handling thereof and labelling of packaging”;
  • ”Conditions and procedure for handling of narcotic drugs and psychotropic substances for medical and research purposes, and conditions and procedure for maintaining records and reporting in that area and schedules of narcotic drugs and psychotropic substances”;
  • Regulation of the Government of the Republic “Threshold values for mark-ups in wholesale and retail trade of medicinal products and the procedure for their implementation”.

Requirements for the applicant

To receive an activity licence, you must comply with the following requirements:

  • You are a self-employed dispensing chemist, you have a majority holding in a private company (non-profit associations excluded) or you are a legal person governed by public law.
  • The shareholders of the company do not include owners of an activity licence for wholesale distribution or manufacture of medicinal products for or provision of health care services nor any traders whoare connected to the company through control in the meaning of the Competition Act, persons qualified to prescribe medicinal products or veterinarians holding a valid activity licence.
  • You do not have a valid activity licence for wholesale distribution or manufacture of medicinal products (exception: the applicant for an activity licence for hospital pharmacy may have an activity licence for manufacture of medicinal products for manufacture of whole blood and blood components and the packaging, labelling, re-packaging or re-labelling of medicinal products for clinical trials).
  • The holder of an activity licence for hospital pharmacy may not have a secondary field of activity besides the provision of pharmacy service, manufacture of whole blood or blood components or activities specified in subsection 22 (3) of the Health Services Organisation Act.
  • The holder of an activity licence for general pharmacy and veterinary pharmacy must not provide health care or veterinary services.
  • You are not subject to any other limitation listed in sections 42–43 of the Medicinal Products Act.
  • You have suitable conditions, means and personnel for the provision of pharmacy services, namely: a person employed as the head of a pharmacy must not, at the same time, be employed by the holder of an activity licence for wholesale distribution or manufacture of medicinal products; the head of a pharmacy in a city with more than 4000 residents must not work in another pharmacy; a person employed as a competent person with a wholesaler of medicinal products must not, at the same time, work at a pharmacy; a veterinarian employed by a general pharmacy or veterinary pharmacy must not provide veterinary services.
  • You have no tax arrears or they have not been staggered.
  • The records of the Criminal Records Database show that your business, the representative of your business or a competent person have not been punished for a crime of the first degree, an offence against the state or property, or an offence committed while handling medical products, and that you are not a fugitive or a suspect or the accused in a criminal offence.
  • You are not subject to liquidation proceedings, a decision of termination or a declaration of bankruptcy.
  • You have paid the state fees.

Cross-border activity

A trader who operates in the field of pharmacy services in another country of the European Economic Area and wishes to start operations in Estonia must apply for an activity licence for pharmacy services from the State Agency of Medicines.

A dispensing chemist or a pharmacist who has received his/her professional certificate in a foreign state and wishes to work in Estonia must be registered in the Health Board’s register for dispensing chemists and pharmacists.

Information about operating in another state of the European Economic Area is available at the EUGO Point of Single Contact of the relevant state.

An activity licence for pharmacy services issued in Estonia is valid only in the Republic of Estonia.

Completing and submitting a notice

For the receipt of an activity licence, please submit an application and the requested documents to the State Agency of Medicines. A person authorised to represent the applicant (e.g. a Member of the Board) and a competent person must sign the application.

Application for activity licence for a general pharmacy (.doc, 32kB).

Application for activity licence for a hospital pharmacy (.doc, 29 kB.)

Application for activity licence for a veterinary pharmacy (.doc, 29 kB).

You can submit the application:

NB! Please pay the state fees before submitting your application.

Payment of state fee

Please pay the state fee for the application for an activity licence in the amount of 150 euros to the bank account of the Ministry of Finance, adding the reference number 2900082281:

  • Swedbank - EE93 2200 2210 2377 8606;
  • SEB - EE89 1010 2200 3479 6011;
  • Danske Bank - EE40 3300 3334 1611 0002;
  • Nordea - EE70 1700 0170 0157 7198.

For an application for distance selling rights (internet pharmacy), an additional state fee in the amount of 75 euros applies (225 euros in total).

For the amendment of an activity licence, please pay the state fee established for each amendment:

  • 75 euros (changing the place of business, adding a structural unit or opening an online pharmacy)
  • 20 euros (changing the head of pharmacy or secondary conditions).

Processing of an application

The State Agency of Medicines shall process a submitted application that complies with the requirements for up to 60 days.

You will be notified of the decision on the grant of an activity licence by e-mail on the address specified in the application form or, in its absence, by letter delivered by regular mail.

If the information in the application or the submitted documents is incomplete, the State Agency of Medicines shall contact you at the earliest opportunity. You will be given an opportunity to eliminate deficiencies within a set term. If the deficiencies are not eliminated by the term set, the State Agency of Medicines can refuse from processing the application. When deficiencies are eliminated, the decision on granting the activity licence shall be made within 60 days from the removal of deficiencies.

If a need to ask for clarifications or additional information arises or circumstances preventing the issue of an activity licence become evident upon processing an application, and such circumstances can be eliminated, the State Agency of Medicines will grant the applicant a reasonable term for the provision of additional information or elimination of the circumstances.

The term prescribed for processing an activity licence is extended until the clarifications or information is provided or the preventing circumstances are removed.

An activity licence is granted without a term unless you request an activity licence issued for a specified term. In this case, you can send the State Agency of

Medicines an application for a new activity licence at the end of the term.

Changing the conditions of a licence

If you wish to change information of your activity licence (e.g. information about the holder of activity licence, place of business, competent person, secondary conditions), please submit an application for amendment of an activity licence with relevant documents to the State Agency of Medicines.

Application for the amendment of an activity licence for a general pharmacy (.doc, 30 kB).

Application for the amendment of an activity licence for a hospital pharmacy (.doc, 29 kB).

Application for the amendment of an activity licence for a veterinary pharmacy (.doc, 30 kB).

NB! Please check before submitting your application, if a state fee has been established for the amendment for which you applied, and pay it, if necessary.

You can submit the application:

Suspension of an activity licence and termination of economic activity

If you wish to suspend or terminate your activity, please submit a written application to the State Agency of Medicines:

  • by e-mail to info@ravimiamet.ee;
  • by regular mail to the State Agency of Medicines at Nooruse 1, 50411 Tartu.

Please state the reasons for suspending or terminating activity and the period of suspension in your application.

The application must be signed by a person authorised to represent the holder of the activity licence (e.g. a Member of the Board). Please submit the application at least 30 days before the suspension or termination of activity.

Revocation of an activity licence

The State Agency of Medicines revokes an activity licence, if:

  • you intentionally submitted incorrect information upon application for an activity licence, which affected the grant of a licence, provided that if such information had not been submitted, the grant of an activity licence would have been denied;
  • you terminate the provision of pharmacy services;
  • you are prohibited from providing pharmacy services.

The State Agency of Medicines may revoke an activity licence, if:

  • the provision of pharmacy services is not commenced within 12 months as of the issue of the activity licence or within a term prescribed in the activity licence or the pharmacy service is not provided for a period of 12 months;
  • you fundamentally breach the requirements of providing pharmacy services or secondary conditions of the activity licence;
  • a secondary condition of the activity licence, which serves as a prerequisite for the validity of the activity licence , has not been fulfilled.

If an activity licence for pharmacy services has been revoked, you can apply for a new one at any time. If an activity licence has been revoked during the preceding year because of a breach of requirements of the provision of pharmacy services or secondary conditions of the activity licence, you must add a plan for compliance with diligence obligation to your application. The plan of compliance with diligence obligation must demonstrate how you plan to ensure the future fulfilment of the requirements of the provision of pharmacy services or secondary conditions of the activity licence, the violation of which was the cause for revocation of the previous activity licence.

Supervision

The State Agency of Medicines exercises governmental supervision over the provision of pharmacy services.

The Health Board exercises supervision over medical devices sold in pharmacies.

The Veterinary and Food Board exercises supervision over food supplements sold at pharmacies.

Contact information

Substantive information

State Agency of Medicines

Phone: +372 737 4140, e-mail: info@ravimiamet.ee

Last amended: 01-12-2016 15:51 | Compiled by: Agency of Medicines