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Update - MRP in Hungary as CMS

Regulatory Affairs - Hungary

Written by David

Saturday, 24 May 2008

Update - New applications for marketing authorisation with Hungary as Concerned Member State

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

4 copies of Application Form (being published in Notice to Applicants, Volume 2B)
the supporting documentation in CTD-format (Common Technical Document) being 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 of fees (see: http://www.ogyi.hu/?tPath=/view/&documentview_type=save&documentview
_site=3208&documentview_id=9019); (fees have to be paid in advance)
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 National Institute of Pharmacy.
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. The Authority will accept expert’s opinion concerning the Braille text from any association of blind people officially registered in Hungary or in the EU.

Typical deficiencies in MRP applications

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 day 85.
Risk Management Plan – Module 1.8
Annex 6.22
coloured mock-up

Special requirements:

Fees to be paid in advance, please insert the proof of payment to the application documentation

Mock ups or Braille decl.: if you do not have HUN mock-ups with Braille, the MAH have to declare that you will apply mock-ups with Braille within the 90 days

Readability test decl.: if you do not have readability test, the MAH have to declare that you will apply readability test within the 90 days

Additional data:

patent + data exclusivity statement,

TSE table or statement or Certificate of Suitability,

Identity statement that the documentation is the same is the approved RMS one,

Statement of compliance with GMP

Samples (you have to submit them before day 40)

Active substance: 5 g with a corresponding analytical certificate which must include - name of manufacturer (or supplier if different), date of manufacture and analytical results (with cert. of analysis)

Finished product: One sample of medicinal product (per strength) from each type of immediate packaging should accompany the application, or should be submitted before the day 40 of the procedure. The sample in final immediate packaging may be submitted without final labelling, but analytical certificate is needed.

Copies:

Either: 1 full paper documentation

Or: (if you have low quality electronic CTD documentation – not eCTD) Modules 4-5 can be submitted only on CD, other modules as paper documentation

Or: (If you have a complete eCTD - with hyperlinks - or an Electronic CTD with bookmarks and hyperlinks, Modules 2-5 can be submitted on CD. Module 1 is still needed in paper format.

Additional copies:

1 paper copy of Module 1.1,

3 paper copies of Application Form + Annexes, and

2 paper copies of Module 1.3

Address:

National Institute of Pharmacy
Zrínyi u. 3.
1051 BUDAPEST
Hungary

Payment details

Fees

MRP, Hungary is CMS, Generic application: HUF 1,175,000 per strength

MRP, Hungary is CMS, Original application: HUF 2,250,000 per strength

Bank details

Name: National Institute of Pharmacy - Hungary
Address: 1051 Budapest, Zrínyi u. 3.
Name of Bank: Hungarian State Treasury
Address of Bank: 1139 Budapest, Hungary, Váci út 71.
Account number: 10032000-01492695-00000000
Tax number: 15310037-2-41
VAT number: HU 15310037
IBAN number: HU25 1003 2000 0149 2695 0000 0000
SWIFT code: MA NE HU HB

Please, contact FarmavitaR+ for local regulatoy affairs suuport in Hungary.

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