Activity licence for the procurement and handling of cells, tissues and organs

You need to apply for an activity licence for procurement, if your activity is related to the:

  • removal,
  • labelling,
  • packaging,
  • and distribution of cells, tissues and organs of human origin.

You need to apply for an activity licence for handling, if your activity is related to the

  • description,
  • coding,
  • labelling,
  • testing,
  • preservation,
  • processing,
  • packaging,
  • storage,
  • release, and
  • distribution of cells, tissues and organs of human origin.

The handling of blood products in the meaning of the Blood and the Medicinal Products Act requires an activity licence for the handling of medicinal products.

Activity licences are issued by the State Agency of Medicines.

The activity of a procurer and handler of cells, tissues and organs is regulated by:

Requirements for the applicant

Recipients of the activity licence for procurement and recipients of the activity licence for handling must comply with the following requirements:

  • You have an activity licence for the provision of specialised medical care issued by the State Agency of Medicines.
  • You have suitable conditions, means and personnel for the procurement of the cell, tissue or organ for which you applied.
  • You do not have tax arrears or they have not been staggered.
  • You are not subject to liquidation proceedings, a decision of termination or a declaration of bankruptcy.
  • You have paid the state fees.
  • The records of the Criminal Records Database show that your business, the representative of your business or a competent person has 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.

Cross-border operation

A trader who operates in the field of procurement/handling of cells, tissues and organs in another country of the European Economic Area and also wishes to start operations in Estonia must apply for an activity licence or conclude a corresponding agreement with an undertaking that already has an activity licence for the procurement/handling of cells, tissues and organs in Estonia.

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

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

Filling in and submitting the 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 of 1700 euros for the application for the issue of an activity licence for handling of cells, tissues and organs, and a state fee of 665 euros for the review of an application for an activity licence for handling of cells, tissues and organs to the Ministry of Finance bank account with reference number 2900082281:

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

A state fee shall be paid in the following amount for the review of an application for the amendment of an activity licence for handling of cells, tissues and organs:

  • 640 euros, if the amendment or addition of a place of business of a handler, and amendment or addition of the secondary conditions of an activity licence are applied for;
  • 320 euros if, upon making amendments, the change of the holder of the activity licence, change of the competent person, change or adding of an undertaking providing services related to the handling to a handler, making changes to the ventilation system or water system of handling facilities and changes in the handling process and equipment used, which are caused by handling of infectious biological material, are applied for.

A state fee shall be paid in the following amount for the review of an application for the amendment of an activity licence for procurement of cells, tissues and organs:

  • 255 euros, if amendment or addition of a place of business of a procurement source, and amendment or addition of secondary conditions of an activity licence are applied for;
  • 130 euros, if making amendments due to change of the holder of activity licence, change of the responsible person, change or addition of an undertaking providing services related to the procurement to a procurement source and changes in the procurement process, which are caused by handling of infectious biological material, are applied for.

Processing the 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 data of the activity licence

Applications for amendment of an activity licence must be submitted to the State Agency of Medicines in accordance with the procedure described in the Procurement, Handling and Transplantation of Cells, Tissues and Organs Act.

A handler must apply for amendment of an activity licence for:

  • changing or adding a place of business for handling;
  • changing or adding a secondary condition of activity licence;
  • changing the owner of activity licence;
  • changing the competent person:
  • changing or adding a trader providing handling services to the handler;
  • making changes to the ventilation or water system of the handling facilities;
  • changes in the handling process and equipment used in the handling process of infectious biological material.

The State Agency of Medicines must be notified of an intention to change and of the change to circumstances related to the subject of review of an activity licence no less than 30 days in advance. Please check before the submission of the application if your specific change is subject to a state fee, and pay the state fee, 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 the activity licence

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

  • you intentionally submitted incorrect information upon applying 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 are subject to a prohibition of economic activities.

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

  • you have not commenced economic activities in the field of procurement or handling of cells, tissues and organs within two years from the issue of the activity licence or within the term prescribed in the activity licence;
  • you fundamentally breach a requirement of an economic activity in the subject of review of the activity licence or a secondary condition 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 violation of handling requirements or secondary conditions, 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 handling requirements or secondary conditions, the violation of which was the cause for revocation of the previous activity licence.

Supervision

The procurement and handling, including compliance with the quality and safety requirements of cells, tissues and organs, is supervised by the State Agency of Medicines.

The Health Board exercises supervision over the specialized medical care providers, whose practice involves the transplantation of cells, tissues and organs.

Contact details

Substantive information

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

Last amended: 01-12-2016 11:32 | Compiled by: State Agency of Medicines