Information necessary for submitting an application for the registration of a new medicine

Official duties in relation to marketing authorization of the medicines belong to the scope of authority of the National Institute of Pharmacy (NIP).The process for issuing the marketing authorization starts on request.

For the evaluation of new registration application you are requested to submit the documents as follows:

• the documentation supporting the application, according to Annex 1 of the 52/2005 (XI. 18.) EüM Decree, in CTD format (Common Technical Documents),
• proof of payment (see Rules: Decree No. 32/2005. (VIII.11.) Eü.M. of the Minister of Health on fees to be paid for administration services related to the authorization procedures of medicinal products for human use),
• additional important information about the details of compiling the dossier can be found in the Notice to Applicants, Volume 2A, Chapter 7 (copy numbers, national characteristics, etc.).
• actual marketing of the pharmaceutical preparation can start, if the final sample is submitted to our Institute, and is accepted by our Institute.
  Your attention is called for §2 (7) of the Decree 30/2005 (VIII. 2.) of the Minister of Health on labelling and package leaflet of medicines of human use, according to which„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”. 
  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 should meet the requirements set out in this Decree for labelling and package insert not later than 31st December, 2010.

The expert opinion of any organization or institution representing the interests of the blind and partially sighted – officially registered in Hungary (or in the territory of EU) – related to the Braille writing is accepted by our Institute!

Validation criteria

- Electronic documentation in CTD structure, in 1 copy

- 1 original, signed copy:

• Application form (declaration and signature)
• Cover letter
• Identity declaration
• Data exclusivity declaration
• Patent declaration (only in case of applications with art 8(3) and art 10b legal base)
• Authorization– Annex 5.4

- Module 1.3.1 documents in electronic (MS Word) format

• Module 1.3.2 Colour mock-up
• Module 1.3.4 Readability test/bridging report

- Proof of payment – with accurate notice (according to the information found on the homepage)

- Sample of the active ingredient- and the final product