Application for an activity licence for wholesale distribution of medicinal products

You need to apply for an activity licence for wholesale distribution of medicinal products for the:

  • import and export,
  • procurement,
  • warehousing and
  • storage of medicinal products for the purpose of wholesale distribution or any other manner of wholesale distribution.

NB! You need an activity licence for manufacture of medicinal products in addition to an import authorisation, if you wish to import and export medicinal products from countries outside of the European Economic Area. For importation of medicinal products, you also have to apply for an import authorisation from the State Agency of Medicines.

Activity licences are issued by the State Agency of Medicines.

The wholesale distribution of medicinal products is regulated by:

  • Medicinal Products Act;
  • Act on Narcotic Drugs and Psychotropic Substances and Precursors thereof;
  • Regulations of the Minister of Social Affairs:
    1. The conditions and procedure for the import and export, carrying for personal use and sending of goods that require a special authorisation of the State Agency of Medicines, the forms of special authorisations and the list of goods that require a special authorisation of the State Agency of Medicines”;
    2. „Conditions and procedure for the wholesale of medicinal products”;
    3. “The conditions of and procedure for repackaging of starting materials for medicinal products by holders of an activity licence for wholesale distribution of medicinal products”;
    4. “The conditions and procedure for storage and transportation of medicinal products”;
  • 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”;
  • Good Distribution Practice prepared on the basis of Article 47(4) and Article 84 of the Directive 2001/83/EC of the European Parliament and of the Council;
  • Requirements of Qualifications of Competent Persons and List of Evidence of Formal Qualification.

Requirements for the applicant

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

  • You are a self-employed person or a private company (non-profit associations excluded) or you are a legal person governed by public law.
  • You do not hold a valid activity licence for manufacture of medicinal products or provision of pharmacy service (exception: the holder of an activity licence for wholesale distribution of medicinal products may concurrently hold an activity licence for altering the labelling and outer packaging of medicinal products, for re-packaging of starting materials used for preparation of medicinal products and for the import of medicinal products from third countries to Estonia and release thereof).
  • You and your subsidiaries are not shareholders or members of a legal person in private law holding an activity licence of a general or veterinary pharmacy.
  • A member of a legal person governed by private law holding an activity licence for a general, hospital or veterinary pharmacy or its subsidiary is not a shareholder or member of you.
  • You are not providing veterinary services.
  • You have the suitable conditions, means and personnel for the wholesale distribution of medicinal products: a veterinarian employed by a wholesaler of medicinal products must not provide veterinary services; a dispensing chemist employed by a wholesaler of medicinal products must not work as a head of pharmacy or a competent person of a manufacturing enterprise; a competent person of a wholesaler of medicinal products must not, at the same time, work at a pharmacy.
  • You have the suitable technical means and qualified personnel for the conditions required for the handling of medicinal products.
  • You have no tax arrears or they have not been staggered.
  • You are not subject to liquidation proceedings, a decision of termination or a declaration of bankruptcy.
  • 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 have paid the state fees.

Cross-border operation

A trader who operates in the field of wholesale distribution of medicinal products in another country of the Europe an Economic Area and wishes to start operations in Estonia must apply for an activity licence for wholesale distribution of medicinal products 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.

Filling and submission of an application

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.

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 1000 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 the amendment of an activity licence, please pay the state fee established for each amendment:

  • 500 euros (changing the place of business);
  • 150 euros (changing the competent person 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 granting an activity licence by e-mail on the address designated in the application form or, in its absence, by letter delivered by regular mail.The activity licence shall be issued on paper by regular mail to the address of the place of business.

If the information in the application or the submitted documents is incomplete, the State Agency of Medicines shall contact you within 10 days as of the submission of the application. You will be granted 14 days for the elimination of deficiencies. The activity licence shall be issued in 60 days as of the elimination 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 the latter case, you can send the State Agency of Medicines an application for a new activity licence at the end of the term.

Changing the data of an activity licence

If you wish to change the 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 amending an activity licence with relevant documents to the State Agency of Medicines.

NB! Please check before submitting your application, if a state fee has been established for the amendment applied for, 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 activity of wholesale distribution of medicinal products;
  • you are subject to a prohibition of wholesale distribution of medicinal products.

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

  • the wholesale distribution of medicinal products 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 wholesale distribution of medicinal products is not continued for a period of 12 months;
  • you fundamentally breach the requirements of the manufacture of medicinal products 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 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 wholesale distribution of medicinal products 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 fulfillment of the requirements of the wholesale distribution of medicinal products or secondary conditions of the activity licence, the breach of which was the cause for revocation of the previous activity licence.

Supervision

The State Agency of Medicines exercises supervision of the wholesale distribution of medicinal products.

Contact information

Substantive information

State Agency of Medicines, phone: +372 737 4140, e-mail: info@ravimiamet.ee

Last amended: 02-12-2016 16:26 | Compiled by: State Agency of Medicines