Disposal of unusable medication - conditions for obtaining the licence

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

This document contains the conditions for granting the consent for the activity of unusable medication disposal.

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Conditions for granting a licence

The entity must be a business entity based on a trade license for handling hazardous waste

Application requirements

  • Commercial name or title, legal form and registered office (for a legal entity), name and surname, commercial name, address and place of business
  • Identification number, where available
  • Identification and address of all operation facilities
  • Name, surname and address of permanent residence or residence of the natural person or natural persons authorised to act on behalf of the applicant (statutory representative)
  • Name, surname of the waste manager
  • Name, purpose and technical description of the facility including all related facilities, description of the technological procedure for handling waste at the facility
  • List of the types of waste which will be handled at the facility
  • Description of access routes to the facility in relation to individual types of waste transportation into the facility
  • Way of storing waste at the facility
  • Proposal for monitoring the impact of facility operation on the environment and human health corresponding to the type of facility and types of waste
  • Plan of professional education for the facility staff
  • Document on permission of the facility according to the Building Code
  • Proposal of the operation code and proposal for introduction of an operation log book

Further information on the licence proceedings

Type of licence

  • Consent

Respective authority

  • Regional authority with local competence

Procedure for granting a licence

  • The applicant must acquire a trade license for handling hazardous waste, and then request a consent from the respective regional office.

Application clearing deadline

  • 30 days from the day when the respective office receives the application, including attachments.


  • 500 CZK

Validity period of the licence

  • Period of validity is not determined.

Legal regulation

  • Act No. 378/2007 Coll., on pharmaceuticals and amendments to some co-related Acts (Pharmaceuticals Act), as amended
  • Act No. 185/2001 Coll., on waste and the amendment of some other Acts, as amended
  • Decree No. 383/2001 Coll., as amended
  • Decree No. 381/2001 Coll., which stipulates the waste catalogue, as amended

Related legal regulations

  • Act No. 500/2004 Coll., Administrative Code

Current Community regulations

  • 32001L0083 as amended by 32114L0027 –  the member states will ensure an implementation of suitable systems for collecting unusable medication or medication with an expired lifecycle

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