Czech Republic Drug Product Registration

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 foet uses, 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.