Validation criteria for new application

The requirements concerning the submission of application.

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

• 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,
• 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.

Validation criteria

- Electronic dossier in CTD structure (1 CD or DVD)

- Originally signed paper:

• Application form (declaration and signature)
• Cover letter
• Declaration of identity
• Data exclusivity declaration
• Patent declaration (only for applications with legal basis Art 8(3) and Art 10b)
• Annex 5.4 Power of attorney - ( Hungarian person who is authorised for communication)

81 § (1) At the time of establishing contact, the client shall designate an agent for service of process, with the relevant power of attorney attached, if:

a) he does not have a home address or registered office in Hungary;

b) he did not officially appoint a representative; and

c) electronic communication is not permitted.

- Module 1.3 product information texts in MS Word

• Module1.3.2 coloured mock-up
• Module1.3.4 readability test/bridging report