You must apply for an activity licence for brokering of medicinal products, if you wish to operate in the field of the organisation of purchase and sales transactions of medicinal products without the physical handling of medicinal products. The activity licence for brokering of medicinal products does not extend to activities related to the wholesale distribution of medicinal products.
The activity of a broker only serves the purpose of introducing traders licenced to handle medicinal products, so that they could conclude a transaction and then physically handle medicinal products. A purchase and sales transaction is concluded between the persons licenced to handle medicinal products.
Activity licences are issued by the State Agency of Medicines.
Legal bases
The brokering of medicinal products is regulated by:
- Medicinal Product Act;
- General Part of the Economic Activities Code Act;
- 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 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 a legal person governed by public law.
- No liquidation proceedings have been initiated against you, no termination decision has been taken or bankruptcy has been declared.
- You have paid the state fees.
Cross-border activity
Activity licences for brokering of medicinal products are issued by the country of the European Economic Area, which is the permanent residence of the broker.
Filling in 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. The application must be signed by a person authorised to represent the applicant.
You can submit the application:
- 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 the state fee
Please pay the state fee for the application for an activity licence for brokering of medicinal products in the amount of 300 euros to the bank account of the Ministry of Finance with the reference number 2900082281:
- Swedbank - EE93 2200 2210 2377 8606;
- SEB - EE89 1010 2200 3479 6011;
- Luminor Bank - EE70 1700 0170 0157 7198;
- LHV Pank EE77 7700 7710 0381 3400.
Additional information on state fees
A state fee of 100 euros applies for the amendment of permanent residence on the activity licence.
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 the deficiencies within a term prescribed. The State Agency of Medicines may refuse to process an application, if the deficiencies have not been eliminated by the term prescribed. The State Agency of Medicines shall make the decision on granting an activity licence within 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 conditions of a licence
If you wish to change the information of your activity licence, please submit an application for the amendment of an activity licence with relevant documents to the State Agency of Medicines. The application must be signed by a person authorised to represent the applicant.
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:
- 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 brokering activities, please submit a written application to the State Agency of Medicines:
You can submit the application:
- 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 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 brokering medicinal products;
- you are prohibited from brokering medicinal products.
The State Agency of Medicines may revoke an activity licence, if:
- you do not commence the brokering activity of medicinal products within 2 years as of granting an activity licence or the activity of brokering medicinal products is not continued for 2 years;
- you materially violate requirements for the brokering of medicinal products or secondary conditions of the activity licence;
- secondary conditions of the activity licence change.
If an activity licence for brokering of medicinal products 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 for brokering 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 fulfilment of the requirements for brokering 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 brokering of medicinal products.
Contact details
Substantive information
State Agency of Medicines, tel: +372 737 4140, e-mail: [email protected]