Types of activity licenses
The Agency of Medicines issues four types of activity licenses for handling medicinal products:
- Manufacturing of medicinal products
- Wholesale distribution of medicinal products
- Pharmacy services
- Brokering of human medicinal products.
One authorisation holder may have multiple premises, and each premise location has to have a separate activity licence.
Application for activity licences
Procedures related to activity licences for handling and brokering of medicinal products are regulated by the General Part of the Economic Activities Code Act and the Medicinal Products Act.
Each general pharmacy, veterinary pharmacy, hospital pharmacy, or a place of business for wholesale distribution or manufacturing of medicinal producuts mst have a separate activity licence.
An application must be submitted to the State Agency of Medicines for:
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issuing of activity licences;
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amendment of activity licences.
Application forms
Application forms are here (applications are only available in Estonian). Please submit your application electronically to [email protected] or through the Client portal of the State Agency of Medicines.
Signing the application
The application must be signed by a member of the board or an authorized person. The application for an activity licence should be submitted sufficiently in advance, considering the time limit set for its processing. The State Agency of Medicines makes its decision on granting an activity licence within 60 days after the submission of all required documents.
Specific types of activities
For re-labelling and secondary re-packaging, please use the application for an activity licence for manufacturing of medicinal products. In section 7. „ACTIVITIES – specific information on medicinal products“ please indicate „secondary packaging“ under item 1.5 „Packaging“, and add clarifications if necessary. There is a separate sub-section for investigational medicinal products.
For manufacturing of blood components and handling of herbal substances, please use the application for an activity licence for manufacturing of medicinal products. At the top of section 7. „ACTIVITIES“ please indicate „blood components“ or „herbal substances“. Other sub-items of section 7 do not need to be filled in.
Competent person
The application for the handling of medicinal products must be signed (in addition to the applicant for the activity licence) by a competent person designated at the place of business. The main requirements and responsibilities of a competent person are specified in Division 7 “Competent person” of the Medicinal Products Act. The qualification criteria are set forth in the Minister of Social Affairs Regulation No. 42 of 11 March 2005 “Requirements for Qualifications of Competent Persons and List of Evidence of Formal Qualification”.
The competent person must have the required qualifications. They have sufficient knowledge and work experience in the pharmaceutical field. The competent person must have a permanent place of residence in Estonia and be familiar with Estonian legislation. In order to know the Estonian legislation, it is important for the competent person to be able to understand Estonian at a good level.
Accompanying documents
The application for an activity licence must be submitted with accompanying documents listed in the Medicinal Products Act: subsections 46 according to which authorisation is applied.
STATE FEE
The applicant must pay the state fee. More information can be found HERE.
Decision-making process for activity licences
The State Agency of Medicines makes its decision on granting an activity licence within 60 days after the submission of all required documents. If a voluntary revocation of an activity licence is applied for, the decision is made at the earliest opportunity.
The time limit of the decision is extended (by up to 30 days), if the State Agency of Medicines sets a term for:
- the submission of a suitable application or documents;
- the elimination of essential deficiencies hindering the granting of an activity licence;
- providing clarifications.
If an application or documents are submitted, deficiencies are eliminated and explanations are provided before the end of term, the term of processing is concluded with the submission of documents, elimination of deficiencies or provision of explanations.
If a suitable application or documents are not submitted to the State Agency of Medicines within the set term, the State Agency of Medicines can refuse processing the application.
Before making its decision, the State Agency of Medicines checks, within the limits of its competence, the compliance of the conditions of the place of business, the activity of the applicant of the activity licence, and also the staff, if necessary, with the requirements in force. The inspection is mostly executed in the place of business, but the State Agency of Medicines can also use other results and measures of supervision. Please bear in mind that the place of business must meet the requirements in force at the time of processing of the application for an activity licence – otherwise, the State Agency of Medicines cannot determine its suitability and the processing of the application shall be suspended until a term set by the State Agency of Medicines, during which the place of business must be brought into compliance with requirements.
The applicant is asked for additional clarifications or a term is set for elimination of essential deficiencies hindering the grant of an activity licence, if necessary.
An application for an activity licence can be satisfied, if the applicant for an activity licence, the place of business, and the activity of an applicant, on the basis of an activity licence issued earlier, meet the requirements in force.
The State Agency of Medicines satisfies the application for an activity licence in the absence of grounds for refusal to grant an activity licence as set forth in Section 25 of the General Part of the Economic Activities Code Act. Activity licences are granted without a term, unless an applicant requests an activity licence to be issued for a specified term. On the third working day as of the making of the decision at the latest, the State Agency of Medicines forwards to the applicant the decision on the satisfying or refusal to satisfy an application for an activity licence for the handling or brokering of medicinal products, and the activity licence issued for handling of medicinal products.
The owner of an activity licence has:
- the right to operate in accordance with the procedure and on the conditions provided by the Medicinal Products Act and legislation established on the basis thereof in the area of activity, place of business and on the conditions set out in the activity licence.
- the obligation to comply with the requirements arising from the Medicinal Products Act. The holder of the activity licence is always liable for the assurence of proper handling of medicinal products.
- to consider the limitations set forth in sections 42 and 43 of the Medicinal Products Act.
Public disclosure of activity licences for the handling and brokering of medicinal products
Information concerning the activity licence shall be available at the Activity Licence Register from its effective date. Activity licences for the wholesale and manufacturing of medicinal products are additionally available in the EudraGMDP database.
Overview of required documents
(Grounds: Section 46 of the Medicinal Products Act, Clauses 15 (2) 3) and 4) of the General Part of the Economic Activities Code Act and section 19, and section 2 of the Minister of Social Affairs Regulation No. 42 of 11 March 2005 “Requirements for Qualifications of Competent Persons and List of Evidence of Formal Qualification”)
1. Issuing of an activity licence
Application documents:
- Application form published on the website of the State Agency of Medicines
- Proof of payment of the state fee
- Copy of the instrument of incorporation or foundation resolution of the company (for legal persons not entered in the Business Register)
- Document certifying the right of use of the premises (including branch pharmacies)
- Layout and description of the premises (including branch pharmacies)
- Description of the technical equipment (including branch pharmacies)
- Description of the storage of medicinal products (including branch pharmacies)
- Arrangements for the quality control of medicinal products (including branch pharmacies)
Documents regarding the Head of Pharmacy:
- Copy of a document certifying education
- Copy of a document certifying the change of name (if applicable)
- Document certifying the professional career or a CV (workplaces, periods of employment, fields of activity)
- List of completed in-service trainings
Other required information:
- List of professional employees (name, position, professional experience) (including branch pharmacies)
- When applying for the first time – planned number of professional employees (pharmacists, assistant pharmacists)
- Confirmation that there have been no changes to the documents submitted earlier (all must be listed separately
2. Application for amendments to an activity licence
Making amendments to a valid activity licence (e.g. opening a branch pharmacy, change of business name, replacement of the Head of Pharmacy, change of location or name of the pharmacy, etc.)
Required documents:
- Application form published on the website of the State Agency of Medicines
- All documents listed in Section 1 relevant to the amendment applied for
- Documents on the organisation of [distance selling of medicinal products] (opens in a new tab), if the right of distance selling is applied for
- Confirmation that there have been no changes to the documents submitted earlier (all must be listed separately)
1. Issuing of an activity licence
To apply for an activity licence, please submit the following documents:
- Proof of payment of the state fee
- Document certifying the right of use of the premises
- Layout and description of the premises of the place of business
- Description of the technical equipment
- Description of the storage of medicinal products
- Description of the transport of medicinal products
- Copy of the contract for storage and dispensing of medicinal products concluded with a wholesale distribution authorisation holder, if the applicant does not have suitable storage facilities
- Organisation chart reflecting the structure of the wholesale company
- List of professional employees (name, position, professional experience)
- Documents regarding the qualified person:
- Copy of a document certifying education
- Copy of a document certifying the change of name (if applicable)
- Document certifying the career or CV (workplaces, periods of employment, fields of activity
- List of completed in-service trainings
2. Application for amendments to an activity licence
An application for amendments to a valid activity licence must be submitted in the following cases: (e.g. expanding or reducing the scope of authorisation, change of business name, replacement of the competent person, change of location, etc.)
Required documents:
- Application form published on the website of the State Agency of Medicines
- All documents listed in Section 1 relevant to the amendment applied for
- Confirmation that there have been no changes to the documents submitted earlier (all must be listed separately)
1. Issuing of an activity licence
To apply for an activity licence for the manufacture of medicinal products, please submit the following documents:
- Proof of payment of the state fee
- Document certifying the right of use of the premises
- Layout and description of the premises of the place of business
- Description of the technical equipment
- Description of the storage of medicinal products
- Description of the transport of medicinal products
- List of medicinal product groups, pharmaceutical forms or medicinal products to be produced
- List of groups of medicinal products, pharmaceutical forms or medicinal products that are released upon import from non-EEA states
- Scheme and brief description of the manufacturing processes
- Description of sterilisation methods and stages
- List of equipment to be used for manufacturing and quality control, indicating the purpose of each device
- Description of the organisation of maintenance of the premises and equipment
- Description of the organisation of validation and calibration
- List of manufacturing and quality control enterprises performing contract work, including the substance of the contract work
- Description of the quality assurance system
- Description of the organisation of product release
- Classification of the production premises, types of construction and finishing materials
- Schemes of staff and material movement
- Simplified scheme and description of the ventilation system, including filter types
- Simplified scheme and description of the water system and water quality classes used in manufacturing
2. Application for amendments to an activity licence
An application for amendments to a valid activity licence must be submitted in the following cases (e.g. expanding or reducing the scope of authorisation, change of business name, replacement of the competent person, change of location, etc.).
Required documents:
- Application form published on the website of the State Agency of Medicines
- All documents listed in Section 1 relevant to the amendment applied for
- Confirmation that there have been no changes to the documents submitted earlier (all must be listed separately)
Last updated: 29.10.2025
