New Application - English

null New Application

New Application

Veterinary medicinal products can be released, distributed and used in Hungary only when preceded by a registration procedure and the product must have a marketing authorization with a valid MA.

A valid marketing authorization in Hungary is issued

by the European Commission, on the basis of the Regulation of the European Parliament and Council 726/2004/EC following a Centralised Procedure, or
by the DVMP, on the basis of the Decree No. 128/2009.(X.6.) MARD after a National, Decentralised or Mutual Recognition Procedure.

The Application Form to be submitted to the DVMP can be downloaded here: Application form.
For more information about the compilation of the applications see Eudralex Volumes 6A, 6B and 6C.
The Summary of Product Characteristics (SPC), Package leaflet/insert Labelling should be prepared according to the SPC template.
Procedure fees are to be paid in advance.

Attached contents
New Application Form
SPC Template

veterinary medicinal products

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Quality defect

S'ha produït un error mentre es processava la plantilla.

The following has evaluated to null or missing:
==> dateTool  [in template "10155#10195#22629" at line 7, column 33]

----
Tip: If the failing expression is known to legally refer to something that's sometimes null or missing, either specify a default value like myOptionalVar!myDefault, or use <#if myOptionalVar??>when-present<#else>when-missing</#if>. (These only cover the last step of the expression; to cover the whole expression, use parenthesis: (myOptionalVar.foo)!myDefault, (myOptionalVar.foo)??
----

----
FTL stack trace ("~" means nesting-related):
	- Failed at: #assign publish_date = dateTool.toDat...  [in template "10155#10195#22629" at line 7, column 9]
----

1<article class="article-details">

2    <h2>${title.getData()}</h2>

3    <div class="article-image">

4        <img src="${bigimg.getData()}" alt="${title.getData()}" />

5    </div>

6      <#if datebool?? && getterUtil.getBoolean(datebool.getData()) >

7        <#assign publish_date = dateTool.toDate('EEE, dd MMM yyyy hh:mm:ss Z', reserved-article-display-date.getData(), locale) >

8        <date>${dateTool.format("yyyy. MMMM d, EEEE", publish_date, locale)}</date>

9      </#if>

10    <p class="lead">${lead.getData()}</p>

11    ${text.getData()}

12</article>

reporting

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Complaints

In case you have any general question, notice, statement or complaint in connection with the operation of DVMP, or with any veterinary medicinal product, you can download and fill in the Reporting form .

Reporter’s data are handled confidentially.

Without the reporter’s permission DVMP does not inform the other party of reporter’s data.

You may as well report anonymously.

Attached contents
Reporting form

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Quality defect

In case you observe or suspect any change in the physical characteristics or content of a veterinary medicinal product or any disorder during the administration of it, you should immediately report it to the DVMP using the Quality complaint form.

If possible, please attach the objected (open) and an original (intact) sample of the product to the report.
Reporter’s data are handled confidentially.

Without the reporter’s permission DVMP does not inform the other party of reporter’s data.
You may as well report anonymously.

Attached contents
Quality complaint form

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Pharmacovigilance

he aim of the pharmacovigilance system is to increase the safety of the veterinary medicinal products by gathering and analyzing the adverse reactions occurring during their application, see Definitions, as well as the data about assumed lack of efficacy, reactions for the reason of extra label use, eventual residues detected following the end of the withdrawal period and effects damaging the environment, summing up: the pharmacovigilance data. According to the evaluation of the collected data, in well-founded cases, measures limiting the application of the product or amendment of the package leaflet will be able to be taken.

About the details of the pharmacovigilance system see here.

Reports on the observed adverse reactions and other pharmacovigilance data can be made by filling the Reporting form for veterinarians and other health care professionals.

If the marketing authorization holder becomes aware of a serious unexpected and a human adverse reaction, it is obliged to inform the Directorate right away or within 15 days at the latest.
The notification via computer can be made directly by using the Eudravigilance system or after the Directorate's approval, by filling and sending the European Veterinary Pharmacovigilance Reporting Form for MAHs. The Form is to be filled in Hungarian or in English (recommended).

According to the a Decree No. 128/2009. (X.26.) MARD the marketing authorization holder is obliged to prepare a periodic safety update report, and send it to the Directorate.
The content specification and the guideline for the filling are found here: Periodic Safety Update Report (PSUR) and Guideline for PSUR.

Reporting form for veterinarians and other health care professionals

European Veterinary Pharmacovigilance Reporting Form for MAHs

Guideline for the presentation of the Periodic Safety Update Report

PSUR synchronisation - Pilot phase

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Formal Nonconformity

Distribution of veterinary medicinal products with formal defect can be made exclusively in possession of a license. Requests for granting a license related to distribution with formal defect must be submitted to DVMP.

Distribution of veterinary medicinal products with formal defect is regulated by Sections 59-64 of Decree No. 128/2009.(X.6.) FVM (hereinafter referred to as Decree).

Our Directorate published Guidelines and - belonging to it - an Aid, on the rules of licensing procedure of veterinary medicinal products with formal defect.

Distribution of veterinary medicinal products included in the foreign languaged packaging material is regulated by Section 62 of the Decree.

As from 2007, aggregate chart of licences related to distribution with formal defect can be found on the website under menu item Public Information /Pharmaceutical Distribution/ List of Veterinary medicinal products with formal defect.

Expenses of the licensing procedure are regulated by the Tariffs decree.

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