Handling addictive substances and preparations and activities with drug precursors – conditions

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

This document contains the conditions for issuing authorization and additional information about the licensing procedure for activities with handling addictive substances and preparations and handling precursors.

Back to the document “Handling addictive substances and preparations and handling precursors”

Conditions for granting a licence

Permission is granted by the Ministry of Health. There is no legal right to permission to handle addictive substances and precursors.

The permission to handle addictive substances and precursors is authorized only for those activities referred to therein, and in the case of a production permit, the maximum permissible volume of producing addictive substances and preparations can be set therein. Changes in authorized activities or their renewals can be made only on the basis of new authorization to handle these articles. The existing authorization to handle these articles expires upon the issue of new authorization.

The permission to handle these articles can only be issued to a natural person with good character who has permanent residence in the Czech Republic or a legal person established in the Czech Republic. The condition of permanent residence or a registered office in the Czech Republic does not apply in the case of a citizen of a Member State of the European Union, a citizen of the Czech Republic who does not reside in the Czech Republic, or a legal person established in a Member State of the European Union. For legal entities, the good character of natural persons entered in the Commercial Register as persons authorized to act for it shall be demonstrated; for legal entities not entered in the Commercial Register, the good character of natural persons identified in the founding documents as persons authorized to act for it shall be demonstrated. For the purposes of this law, good character means that the natural person has not been convicted of an intentional crime or offence committed by negligence in relation to handling addictive substances, precursors and drugs. In order to demonstrate the good character of the applicant, the Ministry of Health requires an extract from the Crime Register in accordance with special legal regulations. The request for an extract from the Crime Register and the extract from the Crime Register shall be transmitted in electronic form, in a manner allowing remote access.

Permission to handle these articles can be issued only to legal or natural persons with an appointed responsible representative. This does not apply if a natural person – entrepreneur proves that he meets the requirements for the responsible representative.

Application requirements

The application for authorization to handle these articles is submitted on a form issued by the Ministry of Health.

If authorization is sought for the production of addictive substances and preparations, the technological specifications of the intended production shall be included in the application.

Requirements connected to the provision of services by a provider from a different Member State

The entity must have a permit to handle addictive substances and preparations by the Ministry of Health of the Czech Republic.

Further information on the licence proceedings

Respective authority

  • Ministry of Health

Control and supervisory bodies

  • Ministry of Health

Procedure for granting a licence

  • The applicant shall send the application for the permit to the Ministry of Health. The procedure will proceed in accordance with the Administrative Procedure Code.

Application clearing deadline

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

Fees

  • CZK 5,000

Validity period of licence

  • 5 years
  • A person whose permit to handle these articles expires and he intends to continue handling addictive substances and preparations shall submit a request to the Ministry of Health to issue a new permit to handle these articles no later than 6 weeks prior to the expiration of the permit to handle them.

Legal regulation

  • Act No. 167/1998 Coll., on addictive substances

Related legal regulations

  • Act No. 500/2004 Coll., Administrative Code
  • Decree No. 123/2006 Coll., on the record-keeping and documentation of addictive substances and preparations
  • Decree No. 125/2006 Coll., laying down the application forms under Act No. 167/1998 Coll., on addictive substances and on amending certain other acts, as amended
  • Ministry of Health Decree No. 83/2002 Coll., as amended, laying down the list of legal and natural persons with their workplaces, whose activities do not require permission to handle addictive substances, preparations containing them, and precursors
  • Act No. 500/2004 Coll., as amended (Administrative Procedure Code)
  • Act No. 378/2007 Coll., Pharmaceuticals, and on amendments to some related acts (Pharmaceuticals Act), as amended
  • Waste Act and on amending certain other acts, No. 185/2001 Coll., as amended

Current Community regulations

  • Council Decision of 13 September 1999, whereby 4-MTA is designated as a new synthetic drug, which must be subject to control measures and criminal sanctions. (1999/615/JHA)
  • Council Decision of 28 February 2002 concerning control measures and criminal sanctions in respect of a new type of synthetic drug PMMA. (2002/188/JHA)
  • Council Decision 2003/847/JHA of 27 November 2003 concerning control measures and criminal sanctions in respect of new synthetic drugs 2C-I, 2C-T-2, 2C-T-7 and TMA-2
  • Council Decision 2008/206/JHA of 3 March 2008 on designating 1-benzylpiperazine (BZP) as a new psychoactive substance, which is to be subject to control measures and criminal provisions

Back to the document “Handling addictive substances and preparations and handling precursors”