Handling addictive substances and preparations and activities with drug precursors

1. 5. 2014 | Source: Point of Single Contact (PSC) Czech Republic

Handling addictive substances and preparations means the research, production, processing, collection, storage, delivery, and use of addictive substances and preparations, and purchase and sale of addictive substances and preparations, as well as acquiring or losing substantive rights or obligations associated with them, mediating contracts and providing representation when concluding them.

Activities with drug precursors means the export, import and marketing of scheduled substances in category 1, 2 and 3 on the European Union market, business with unscheduled substances, and the supply of reactants and excipients on the EU market.

Application for a permit to handle addictive substances and preparations

  • Those interested in handling addictive substances and preparations must apply for a permit from the Ministry of Health. The application shall be made on a form.

More information on the application and the conditions for obtaining the permit

The application shall be supplemented with:

  1. For the activities in question, a decision documenting permission to handle medicines under the Pharmaceuticals Act or a certificate of compliance with the conditions for engaging in veterinary therapeutic and preventive activities under the Chamber of Veterinary Surgeons Act
  2. Personal information for the extract from the Crime Registry
  3. Proof of permission to conduct business (trade license, business license)
  4. Document containing the consent of the owner of the property with the activities listed in the application
  5. Contract for professional veterinary activities, if this activity is to be performed
  6. Proof of the appointment of the responsible representative
  7. Medical opinion on the medical fitness of the responsible representative
  8. Document validating the education of the responsible representative
  9. Statement of the applicant on the choice of the appropriate safeguards
  10. For obtaining a production permit, the technological specification of the intended production
  11. Proof of payment of the administrative fee of 5,000 CZK.

Application for a license to work with scheduled substances of category 1

  • Those interested in working with scheduled substances of category 1 must apply for a license from the Ministry of Health. The application shall be made on a form.
  • More information on the application and the conditions for obtaining the license

The application shall be supplemented with:

  1. Proof of the appointment of the responsible representative
  2. Proof of the employment or service relationship of the responsible representative
  3. Medical opinion on the medical fitness of the responsible representative
  4. Document validating the education of the responsible representative
  5. For the activities in question, a decision documenting permission to produce or permission to distribute under the Pharmaceuticals Act
  6. For obtaining a production permit, the technological specification of the intended production
  7. Personal information for the extract from the Crime Registry
  8. Proof of payment of the administrative fee of 3,000 CZK.

Application to register for activities with scheduled substances of category 2 or 3 or with reactants and excipients

  • Those interested in activities with scheduled substances of category 2 or 3 or with reactants and excipients must register with the Ministry of Health. The application shall be made on a form.
  • More information on the application and the conditions for registration

The application shall be supplemented with:

  1. Personal information for the extract from the Crime Registry
  2. Proof of the appointment of the responsible representative or contact person
  3. Proof of the employment or service relationship of the responsible representative
  4. Foundation charter
  5. For production, the technological specification of the intended production
  6. Proof of payment of the administrative fee of 3,000 CZK or 500 CZK in the case of reactants and excipients

Further information on the licence proceedings

The authority shall grant authorization within 30 days, for first-time applicants usually within 60 days.

The business may be conducted after fulfilling all the above stated requirements.

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