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Czech Republic Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH: Ministry of Health of the Czech Republic

MoH Website: https://www.mzcr.cz/en/the-ministry-of-health/

Regulatory Agency: State Institute for Drug Control (SUKL)

Regulatory Agency Website: http://www.sukl.eu/

Local Authorised Representative: Yes

Application for Marketing Authorisation,  national procedure Fees:

  • New active substance: 9 600,00 €
  • generic application: 8 000,00 €

Application for Marketing Authorisation , MRP/DCP – CMS fees

  • New active substance: 6 000,00 €
  • Generic application: 5 000,00 €

Application for Marketing Authorisation, MRP/DCP – RMS Fees

  • New active substance: 11 000,00 €
  • Generic application: 9 000,00 €

Marketing Authorisation Renewal Fees

  • National procedure: 5 000,00 €
  • DCP/MRP – CMS: 4 000,00 €
  • DCP/MRP – RMS: 5 000,00 €

Type II Variations Fees

  • National procedure: 4 000,00 €
  • DCP/MRP – CMS: 3 200,00 €
  • DCP/MRP – RMS: 5 000,00 €

Type 1A, 1B Variations Fees

  • National procedure: 200,00 €
  • DCP/MRP – CMS: 200,00 €
  • DCP/MRP – RMS: 200,00 € 

Marketing Authorization of Pharmaceuticals

  • the Market Authorization Holder (MAH) must meet all the requirements listed out by the European Union (EU) and European Economic Area (EEA)
  • Any patented pharmaceutical product is subject to marketing authorization prior to its placement on the market in the Czech Republic.
  • A dossier including evidence of the product’s quality, safety, and efficacy is evaluated as part of the marketing authorization procedure by the future marketing authorization holder (MAH).
  • In addition, the indications, contraindications, product dose, general classification for supply, and the package leaflet for the patient and proposed texts on the labelling of the medicinal products are evaluated.
  • The Summary of Product Characteristics (SPC) forms is a part of the marketing Authorisation.
  • For physicians and other healthcare professionals, it is the key source of information on medical products.
  • Application forms for marketing authorisation of medicinal products for human use, their renewal or variation are currently being revised, till then the following guideline should be followed:

 EUDRALEX, Volume 2 – Pharmaceuticals Legislation: Notice to Applicants.

Pharmacovigilance

  • Post-authorization surveillance for pharmaceuticals aims to ensure the highest level of safety and as beneficial risk/benefit ratio of the product.
  • These activities include the identification, evaluation, understanding, and prevention of adverse drug reactions or problems such as medication abuse or misuse, drug interaction, effects on developing foetuses, impacts on breast-fed infants, etc.

Legislation

  • Act No 378/2007 Coll., on pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”) came on December 31. 2007. Title V, section 90 – 96.
  • Decree No 228/2008 Coll., on the marketing authorisation of medicinal products, as amended; section 14-17.
  • SUKL guidelines: PHV 3; Non-interventional post-authorization safety studies; PHV 4: Electronic Adverse Drug Reaction Reports; and PHV 5: Plan for transfer of pharmacovigilance responsibility.
  • Volume 9 of the European Union’s Guidelines on Pharmacovigilance for Medicinal Products for Human Use contains the rules governing medicinal products.

Adverse Drug Reaction (ADR) reporting 

  • The newly expanded EudraVigilance database was put into place on 22nd November 2017.
  • As of this date, reports from all EV stakeholders must be immediately submitted to the EV database (centralized reporting system) within the legally mandated time frames:
    • All EU serious reports: Report to the EV database within 15 days (From the date the expanded EudraVigilance database is put into operation)
    • All EU non-serious reports: Report to the EV database within 90 days (From the date the expanded EudraVigilance database is put into operation)
    • Non-EU serious reports: Report to the EV database within 15 days (From the date the expanded EudraVigilance database is put into operation)
  • Reports (ICSRs) of drug overdose, drug interaction, MP abuse, medication error, or MP off-label usage should not be submitted to the EV database if they are not connected to a concurrent adverse drug response. For the goal of possibly evaluating the particular product’s risk/benefit ratio, they should be noted and observed by the MAH.