Validation criterions for new application

In case of a new application for marketing authorisation applicant should submit the documentation according to the following requirements:

• 4 copies of Application Form beeing published in Notice to Applicants, Volume 2B,
• the supporting documentation in CTD-format (Common Technical Document) beeing compiled according to Annex I. to the Decree No. 52 of 18 November, 2005 of the Minister of Health; this is harmonized with the Annex I. to Commission Directive 2003/63/EC,
• proof of payment,
• submission of electronic format (eCTD) is also possible – if so, please submit 4 copies of Application Form and the certificates in paper form, the CD should contain the remaining parts in hyperlinked version,
• further details of the dossier can be found in Notice to Applicants, Volume 2A, Chapter 7 (number of copies, special national requirements etc.).
• the actual marketing of the medicinal product may be started after the final sample is submitted, to and accepted by our institute.
  Please note, that according to §2 (7) of the Decree 30/2005 (VIII. 2.) of the Minister of Health on labelling and package leaflet of medicines of human use „The name of the medicinal product and its strength, if more than one strengths are marketed, must also be expressed in Braille format on the outer packaging. If there is no outer packaging, this information should be expressed on the immediate packaging.”
  Measures regulated by above mentioned Decree shall first be implemented in the case of marketing applications submitted after the date of coming this Decree into effect.( October 30,2005) Medicinal products already having marketing authorization at the time of coming this Decree into effect shall meet the requirements set out in this Decree for labelling and package insert not later than 31st December, 2010.

Our Authority will accept expert's opinion concerning the Braille text from any officially registered in Hungary or in the European Economic Area-blind and partially sighted people union/association.

Typical deficiencies

• samples of the active substance and the final medicinal product with analytical certificates

- if the samples cannot be submitted during the validation period, please declare to do so until day 50 of the procedure

• Patent Declaration in case of generic applications
• declaration of Braille – to be on the final product
• Readability Test

- if the test cannot be submitted during the validation period, please declare that it will be completed until

- day90 in a national procedure

- day85 in an MRP

- day106 in a DCP

• Risk Management Plan – Module 1.8
• Annex 6.22