Disposal of unusable medication - licencing step by step

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

The disposal of unusable medication refers to the liquidation of medication of an inadequate quality, expired lifetime and the liquidation of obviously damaged or unused medications by a natural person or legal entity based on consent granted by the regional authority.

Applicants for the disposal of unusable medication must first obtain a trade license for a business in handling hazardous waste, and then request consent from the respective regional office.

Procedure for obtaining authorisation:

  1. Notification of a professional trade
  2. Application for granting of consent

1) Notification of a professional trade

The notification is submitted:

  1. at any trade licence office
  2. via public administration contact points (the so-called Czech POINT) – in Czech only
  3. electronically, via the information system provided by the Register of Trade Business

Form of submission

Notification may only be submitted using the so-called Single Registration Form.

Conditions for conducting the trade + notification requisites and appendices

Further details/appendices relating to the notification

Documents evidencing professional competence should be attached to the notification. In this instance, professional competence shall mean the following:

  1. Higher education and one years’ experience in the profession, or
  2. further vocational education in a technical or scientific field of study and 3 years’ experience in the profession, or
  3. secondary education with a school-leaving examination in a technical or scientific field of study and 3 years experience in the profession, or
  4. a retraining certificate or other evidence of professional qualification for the relevant employment activities, issued by an establishment accredited in accordance with specific legislation, or by an establishment accredited by the Ministry of Education, Youth and Sports, or by a ministry in whose purview the sector in which the trade is operated falls, and 4 years’ experience in the profession.

Besides these documents, no other facts need to be evidenced for this trade.

If the conditions for trade notification stipulated by the Trade Licensing Act have been met, the trade licence office shall make an entry in the Trade Register within 5 days of the delivery of the notification and shall issue a copy of the entry to the business person.

2) Application for granting of consent

  • The application is submitted to the relevant regional authority.
  • There is no prescribed form for the application.

The application shall be supplemented with:

  1. Trade license (see above)
  2. Document of ownership of the facility or lease contract
  3. Operation code with the following requirements:
    • Basic information about the facility
    • Character and purpose of the facility
    • Brief description of the facility
    • Technology and servicing of the facility
    • Monitoring facility operation
    • Organisational assurance of facility operation
    • Waste record management
    • Measures to limit the negative impact of the facility and emergency measures
    • Operational safety and environmental protection and human safety
    • Proposal for introduction of an operational log book
  4. Receipt of payment of the CZK 500 administrative fee

Additional information about the conditions of granting authorisation and permit proceedings

The authority will grant the license within 30 days.

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

Related information:

If you have any questions, you can contact Points of Single Contact (PSC) set up at 15 municipal trade licence offices in all regions. More information on PSCs.

You can write your comments and proposals in the discussion forum.