Distribution of Medicinal Products - licencing step by step

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

The activity consists of distributing registered and non-registered medicinal products, their parallel import, distributing specific medicinal programmes and promotional samples.

Persons wanting to conduct this activity must first obtain the relevant trade licence. In this case, notification of an unqualified trade will suffice, whereby the notifier becomes entitled to trade on the day of notification. Subsequently, a permit to distribute medicinal products must be applied for from the State Drug Control Institute. For providers based in another EU Member State, notification need only be made that the activity is being carried out in the Czech Republic.

Procedure for obtaining authorisation:

  1. Notification of an unqualified trade
  2. Licence application for the distribution of medicinal products

1) Notification of an unqualified 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:

The notification may only be submitted using the so-called standard registration form.

Conditions for carrying out a trade + notification requirements and appendices

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) Licence Application for the distribution of medicinal products

The application shall include the following:

  • an extract from the Commercial Register or Trade Licence and/or Memorandum of Association or Statute issued by the relevant state authority. An extract from the Commercial Register may be applied for at any public administration contact point (the so-called Czechpoint).
  • a document attesting to right of use of the distribution space, which typically involves a lease agreement or entry from the list of ownership
  • approval to process personal data and a questionnaire for distributors of medicinal products indicating details on compliance with the requirements for good distribution practice, which is a part of the sample application
  • Documentary proof attesting to payment of the administrative fee. Payment of the fee shall be governed by the SUKL - UST 29 practice.

Further information on the licence proceedings

The authority shall grant the licence within 90 days.

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

Licence holders from another EU Member State

Notification that distribution of medicinal products is to commence

The licence to distribute medicinal products issued in another Member State shall be appended to the notification.

The authorisation shall become valid upon notification.

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

Related information: