You need to apply for an activity licence for procurement, if your activity is related to the:
- selection of a donor,
- removal,
- labelling,
- packaging,
- encoding
- 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.
Legal bases
The activity of a procurer and handler of cells, tissues and organs is regulated by:
- Procurement, Handling and Transplantation of Cells, Tissues and Organs Act;
- Artificial Insemination and Embryo Protection Act;
- General part of the Economic Activities Code Act.
- Criteria for the selection of cell, tissue and organ donors, list of factors excluding the donation of cells, tissues or an organ, list of laboratory testing compulsory for a donor and the and the conditions and procedure for the testing;
- Rules for procurement and handling of cells, tissues and organs;
- Requirements for the preparation of reports on the procurement, handling and transplantation of cells, tissues and organs, the composition of data and the procedure of submission;
Requirements for the applicant
Recipients of the activity licence for procurement must comply with the following requirements:
- You have an activity licence for the provision of specialised medical care issued by the Health Board.
- You have suitable conditions, means and personnel for the procurement of the cell, tissue or organ for which you applied.
- You have paid the state fees.
Recipients of the activity licence for for handling must comply with the following requirements:
- You have suitable conditions, means and personnel for the handling of the cell, tissue or organ for which you applied.
- You have paid the state fees.
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.
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 person responsible for procurement and/or competent person must sign the application.
You can submit the application:
- In the client portal of the State Agency of Medicines (prior registration necessary);
- by e-mail to [email protected];
- by regular mail to the State Agency of Medicines at Nooruse 1, 50411 Tartu.
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;
- Luminor - EE70 1700 0170 0157 7198;
- LHV Pank EE77 7700 7710 0381 3400.
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
The principles of licence application shuold be followed when applying for amendment of an activity licence. For the amendment 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 person responsible for procurement and/or competent person must sign the application.
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.
If such a change has been undertaken for the reasons the licence holder cannot fully control, the State Agency of Medicines must be notified as soon as possible, but not later than within 5 working days after the change in question.
Therefore, State Agency of Medicines must be notified about all the changes in the conditions and documents, based on which the activity licence was issued. Examples of most common changes would be:
- change of the place of business (including within the same building);
- change in the plan of the rooms;
- termination of employment contract of person responsible for procurement and/or competent person;
- change in secondary conditions of activity licence;
- changes related to the holder of activity licence (including change of the legal person in private law or change in the activity licence for the provision of special medical care);
- change in the rental agreement;
- significant reorganisation of the activities etc.
You can submit the application:
- In the client portal of the State Agency of Medicines (prior registration necessary);
- by e-mail to [email protected];
- by regular mail to the State Agency of Medicines at Nooruse 1, 50411 Tartu.
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 [email protected];
- 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: [email protected]
Laws
- Procurement, Handling and Transplantation of Cells, Tissues and Organs Act
- Artificial Insemination and Embryo Protection Act