Activity licence for manufacture of medicinal products

An activity licence for manufacture of medicinal products is required for the total or partial manufacture of medicinal products. Medicinal products include, among other things, blood products, medicinal products for clinical trials, active substances of medicinal products and herbal substances categorised as medicinal products. The manufacture of medicinal products is deemed the

  • preparation,
  • sterilisation,
  • packaging and re-packaging,
  • labelling and re-labelling,
  • quality control, and
  • release of batches of medicinal products together with related procuring, receipt, storage and distribution of materials.

An activity licence for manufacture of medicinal products is not mandatory, if the activities are carried out by the holder of an activity licence of general pharmacy, hospital pharmacy or veterinary pharmacy within the scope of the activity licence.

An activity licence for manufacture of medicinal products is not mandatory for t he manufacture of investigational medicinal products, if the packaging, labeling, re-packaging or re-labeling of the medicinal products is carried out at a hospital pharmacy, and the medicinal products are used exclusively at the hospital operated by the person who formed the hospital pharmacy.

You also need an activity licence for manufacture of medicinal products for the importation of medicinal products from countries outside of the European Economic Area and the dispensing thereof. You additionally need to apply for an import authorization from the State Agency of Medicines for the importation of medicinal products.

Activity licences are issued by the State Agency of Medicines.

The manufacture of medicinal products is regulated by:

  • General part of the Economic Activities Code Act;
  • Medicinal Products Act;
  • Act on Narcotic Drugs and Psychotropic Substances and Precursors thereof;
  • Good Manufacturing Practice prepared on the basis of the directive of the European Parliament and of the Council;
  • Good Distribution Practice prepared on the basis of the directive of the European Parliament and of the Council;
  • Regulations of the Minister of Social Affairs: ”A list of herbal substances, and the conditions and procedure for handling thereof and labelling of packaging”; ”Rules for manufacture of medicinal products”; “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”; “Conditions and procedure for storage and transportation of medicinal products”; “Requirements for Qualifications of Competent Persons and List of Evidence of Formal Qualification”; ”Conditions and procedure for handling of narcotic drugs and psychotropic substances for medical and research purposes, and conditions and procedure for maintaining records and reporting in that area and schedules of narcotic drugs and psychotropic substances”.

Requirements for the applicant

Recipients of an activity licence 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.
  • You do not hold a valid activity licence for the wholesale distribution of medicinal products or for provision of pharmacy service, with the exception of: a holder of an activity licence for a hospital pharmacy who applies for an activity licence for manufacture of medicinal products for the manufacture of full blood and blood components and for packaging, labelling, re-packaging or re-labelling of investigational medicinal products; a wholesaler of medicinal products who applies for an activity licence for manufacture of medicinal products 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 governed by private law holding an activity licence for a general or a 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 manufacture of medicinal products: o a dispensing chemist employed by a manufacturer of medicinal products must not, at the same time, be employed as a head of pharmacy; a person employed as the competent person or a substitute for the competent person with a manufacturer must not, at the same time, be employed by a manufacturer of medicinal products or a pharmacy; a veterinarian employed by a manufacturer of medicinal products must not, at the same time, provide veterinary services.
  • You have the suitable technical means and qualified personnel for the conditions required for the manufacture 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 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.
  • You have paid the state fees.

Cross-border activity

A trader, who operates in the field of manufacture of medicinal products in another country of the European Economic Area, and also wishes to start operations in Estonia, must apply for an activity licence for manufacture 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.

Completing and submitting a notice

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 the state fee

For the packaging of herbs, please pay a state fee of 150 euros and for other acts of manufacture of medicinal products – a state fee 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;
  • Luminor Bank - EE70 1700 0170 0157 7198.

Additional information on state fees. For the amendment of an activity licence, please pay the state fee established for each amendment:

  • €500 (changing the place of business);
  • €150 (changing the competent person or secondary conditions);
  • €60 (changing the place of business of a packaging enterprise of medicinal products);
  • €20 (changing the competent person or secondary conditions of a packaging enterprise of medicinal products).

Processing of an application

The State Agency of Medicines shall process a submitted application that complies with requirements for up to 60 days.

You will be notified about the decision on the grant of an activity licence by e-mail on the address designated in the application form or, in its absence, by a 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 for the term prescribed. The State Agency of Medicines shall make the decision on the grant of an activity licence within 60 days from 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 (e.g. information about the holder of activity licence, place of business, competent person, secondary conditions), please submit an application for the amendment of the 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 your application:

Suspension of an activity licence and termination of economic activity

If you wish to suspend or terminate manufacturing activities, 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 manufacturing medicinal products;
  • you are prohibited from manufacturing medicinal products.

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

  • the manufacturing activity of medicinal products is not commenced within 24 months from the issue of the activity or within a term prescribed in the activity licence or the manufacturing of medicinal products is not continued for a period of 24 months;
  • you fundamentally breach the requirements of the manufacture of medicinal products or secondary conditions of the activity licence;
  • you cause significant damage or danger to public order with your manufacturing activity; 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 for the manufacture 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 violation of requirements for the manufacture 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 the manufacture of medicinal products or secondary conditions of the activity licence, the violation of which was the cause for revocation of the previous activity licence.

Supervision

The State Agency of Medicines exercises supervision of the manufacture of medicinal products.

Contact details

Substantive information

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

Last amended: 01-12-2016 15:04 | Compiled by: Agency of Medicines