Distribution of Medicinal products - conditions

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

The document sets forth the conditions for awarding the licence and further information to distribute medicines and the application requirements.

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Conditions for granting a licence

The distribution licence shall be issued to any applicant who has complied with the following requirements:

  1. possesses suitable and adequate space, installed facilities and equipment in order to ensure the proper storage and distribution of medicinal products
  2. has ensured the services of persons meeting the statutory requirements and the services of a qualified person to take responsibility for the distribution, pursuant to the relevant legislation, of the medicinal products and/or medicinal substances and excipients as defined under the scope of the distribution licence; the qualified person must comply with the professional eligibility requirement, according to which they must have completed an accredited university education in the field of healthcare, with a Master’s degree in pharmacy, or an accredited university education in the field of healthcare, with a Master’s degree in general medicine or dentistry, or have an accredited Master’s degree in veterinary science, or Master’s degree in veterinary hygiene and ecology or have completed a Master’s degree in chemistry or biology
  3. demonstrates that they possess the capacity to meet the obligations under Article 77 of the Pharmaceuticals Act

Application requirements

  1. The application for the licence to distribute medicinal products pursuant to Article 76(2) of the Pharmaceuticals Act, shall contain
    1. name, or names, surname, place of business and identification number, (if applicable), of the individual applying for the said licence; where the said licence is requested by a legal entity, their trade name, and/or name, registered address, mailing address and identification number (if applicable)
    2. name, or names and surname of the statutory body or its members where a legal entity is concerned
    3. required type and scope of distribution
    4. addresses of all sites where distribution is performed
    5. name, and/or names, surname, education and experience of the qualified person
    6. phone and fax numbers, e-mail contacts
  2. The appendices to the application for the licence to distribute medicinal products shall consist of:
    1. Extract from the Commercial Register where a person listed in the Commercial Register is concerned, or a Memorandum of Association or Statute issued by the relevant authority in the Czech Republic or another Member State
    2. Documentary proof in support of their right to use premises, buildings, rooms and equipment for the purpose of distributing medicinal products
    3. Information regarding their compliance with the requirements for good distribution practice specified in part 8, in accordance with the requirements published in the Journal of the State Drugs Control Institute, this information should also be presented in way that permits remote access
    4. Documentary proof of their payment of the administrative fee for submitting the application and costs associated with the assessment of the application

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

A holder of a distribution licence issued by the relevant body of another Member State shall enjoy the same rights and obligations in the Czech Republic as a distributor possessing the licence issued by the State Drugs Control Institute. The holder of the distribution licence is obliged to inform the Institute or Veterinary Institute, in advance, of their intention to start distribution in the Czech Republic. In addition, they shall furnish documentary proof of their distribution licence issued by another Member State and provide all data required to ensure co-operation between themselves and the Czech authorities and other information on the scope of distribution and location of distribution warehouses. Where the distribution licence holder establishes distribution warehouses for distribution in the Czech Republic, or where they contract part of their distribution consisting in warehousing in the Czech Republic with another entity that is not a distributor, they shall be liable to the obligation to obtain a permit from the Institute and Veterinary Institute beforehand.

Further information on the licence proceedings

Type of licence

  • Permit by the State Drugs Control Institute – administrative resolution

Respective authority

  • State Drugs Control Institute

Control and supervisory bodies

  • State Drugs Control Institute

Procedure for granting a licence

  • The authority shall grant the permit on the basis of a written request. The authority shall organise an onsite investigation in order to verify the facts stated in the request

Application clearing deadline

  1. request for distribution permit – within 90 days of the request
  2. request for an amendment to the distribution permit – within 30 days, where an on-site inspection is required, within 90 days of the request
  3. request for a withdrawal of the distribution permit  within 30 days of the request

Fees

Administrative fee – Act on the administrative fees – Item 99

Receipt of the Application:

  • permit, or amendment to the permit, to distribute medicinal products – CZK 2,000
  • extension of the distribution permit – CZK 2,000

Reimbursement of costs for professional activities carried out by the State Drugs Control Institute in response to the following requests:

  • request for the distribution permit with an inspection of 1 warehouse – CZK 25,300
    • + for each additional warehouse under a single permit – CZK 13,300
  • rrequest for an amendment to the distribution permit with an inspection of 1 warehouse – CZK 25,300
    • + for each additional warehouse under a single permit – CZK 13,300
  • request for an extension of the licence covering distribution of medicinal products and excipients or human blood and its components or gases used in the provision of health care – CZK 25,300
    • + for each additional warehouse under a single permit – CZK 13,300
  • request for an amendment of the permit without an inspection – CZK 7,400
  • request for withdrawal of distribution licence –  no fee

Validity period of the licence

  • Indefinite term. Where the distributor does not carry out any distribution activities for a minimum duration of 3 years following the date its distribution permit came into legal force, the permit shall cease to be valid

Combined proceedings (recognising qualifications and granting authorisation)

  • Yes, regulated by the Act No. 85/2004 Coll.

Legal Regulation

  • The Act No. 378/2007 Coll., on pharmaceuticals and amendment to some related laws (Pharmaceuticals Act)
  • Decree No. 229/2008 Coll., on manufacturing and distribution of medicinal products
  • Decree No. 143/2008 Coll. on human blood

Related legal regulations

  • Act No. 500/2004 Coll., Administrative Code
  • Act on Administrative Fees
  • Act No. 95/2004 Coll.

Current Community regulations

  • Directive No. 2001/83/EC
  • Guidelines on Good Distribution Practice of Medicinal Products for Human Use as of 5 November 2013 (2013/C 343/01)
  • European Parliament and Council Directive 2002/98/EC as of 27 January 2003, setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/ES
  • Commission Directive 2004/33/EC of 22 March 2004, implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components
  • Commission Directive 2005/61/EC of 30 September 2005, implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events
  • Commission Directive 2005/62/EC of 30 September 2005, implementing Directive 2002/98/EC of the European Parliament and of the Council regarding Community standards and specifications relating to a quality system for blood establishments

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