Quality defect
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>
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
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
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.
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.
Guideline for applicants for wholesale distribution with veterinary medicinal products
The application for the authorisation for wholesale distribution should be submitted to the local government. In case all conditions concerning personnel, layout, documentation system etc. are met, the authorisation for the wholesale is issued by the the local government based on the DVMP's decision.
These conditions are regulated by the Good Distribution Practice. The expenses of the authorization process (including the inspection) are charged to the applicant.
In case any company wishes to perform retailing activity concurrently with the wholesale trade, separate licences have to be applied for and the different activities have to be clearly separated regarding the records of each trading activity.
According to the decree cited, all trading procedures “which can have an influence on the quality of the products or the course of the trading activity” shall be regulated by written operational procedures.
Manufacture and import
Manufacture of veterinary medicinal products shall only be carried out in possession of an authorization. Applications for manufacturing authorisation have to be submitted to IVMPalso in case of partial manufacture, including the quality control of the product. If the marketing authorization holder of a veterinary medicinal product entrusts a contract manufacturing sitemanufacturing, while keeping certain responsibilities of the production (e.g. qualification of the basic ingredients, batch qualification, product release), for those a pharmaceutical manufacturing authorization should also be asked.
The importation is also ranked as a manufacturing process, so the requirements relating to the manufacturing should be applied for the authorization process of that activity as well.
The holder of the manufacturing authorization has to apply for a permission in case of manufacturing for exportation, too. The manufacturing must be carried on according to the GMP requirements.
The applications for the manufacturing authorization should be submitted to the IVMP in two copies. Data should be given according to the operative legislation. Procedure fees are to be paid in advance.
Field trial
A veterinary medicinal product not having a marketing authorization yet, can only be used for testing purposes listed in the j) point of 12.§ (5) article of the Decree No. 128/2009.(X.6.) MARD with the permission of the DVMP.
The requirements for field trials are detailed in Appendix 1 of the Decree.The application shall be submitted to DVMP in a single copy. Apart from the signed experimental protocol the following data shall be listed in the application:
Marketing Authorization
Marketing authorization
Legislation
National and EU Legislation
National Legislation
National Legislation only in Hungarian
Other useful sites
Official Journal of Hungary online
Search engine for Hungarian legislation
SZIE Veterinary Library
Hungarian Veterinary Journal
EU Legislation
Distribution
Wholesalers, Retailers, Retail pharmacies, Veterinary medicinal products with formal defect
Paramedical products
The veterinary animal health care products can be released , distributed and used in Hungary only following a registration procedure according to the 128/2009 (X.6.) MARD as amended by 33/2010 (IV.7.) MARD.
Veterinary biocides
Current legislation is for the marketing authorization of veterinary biocidal products: 33/2010. (IV. 7.) Decree of the Minister of Agriculture and Rural Development on the amendment of FVM (MARD) Decree No. 128/2009. (X.6.) on medicinal products for veterinary use. The 9. § of the current Decree completes the basic Decree with a new section (114/B (2). §) which is concerning the placing on the market, distribution and use of veterinary biocidal products.
As regard the veterinary hygiene biocidal products, for any matters not regulated in this Decree, it is required to apply the rules of the legislation: 38/2003. (VII.7.) ESZCSM-FVM_KvVM on the conditions of production and placing on the market of biocidal products.
Our directorate gives veterinary assessment report to marketing authorization of product-type 3. surface disinfectants from veterinary hygiene biocidal products, and of product-type 5. drinking water disinfectants for animals and disinfection of its water system. Marketing authorization is issued by Office of the Chief Medical Officer of State.
Marketing authorization of product-type 4: Food and feed area disinfectants is issued by National Institute of Food and Nutrition Science (OÉTI).
Public information
List of products, Manufacture, Distribution
List of products
Manufacture
Distribution
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 issuedThe 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
Legislation
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>
Annual report
Representation of DVMP in international organisations
Hungary is represented in the different preparatory and decision-making working-groups in the authorisation and manufacturing of veterinary medicinal products, acting at the Council of Europe and the European Union by the members of the staff of DVMP according to their special expertise. The working-groups operate within the following organizations:
European Medicines Agency (EMA)
European Commission, DG Enterprise (DG Enterprise)
European Directorate for the Quality of Medicines (EDQM)
|
EMA |
|
|
CVMP (Committee for Medicinal Products for Veterinary Use) |
Dr. Gábor Kulcsár |
|
CVMP (Committee for Medicinal Products for Veterinary Use) alternate member |
Dr. Tibor Soós |
|
|
|
|
CVMP WORKING PARTIES |
|
|
Safety Working Party |
Fehérvári Györgyné |
|
Efficacy Working Party |
Dr. Melinda Terényi |
|
Quality Working Party |
Dr. Lívia Németh-Konda |
|
QRD Working party |
Dr. Annamária Mosolygó-Telepó |
|
Immunological Working Party |
Dr. Gábor Kulcsár |
|
GMP ad hoc Working Party |
Dr. János Kovács |
|
Pharmacovigilance Working Party |
Dr. Edit Nagy |
|
Eudravigiliance JIG Working Party |
Dr. Edit Nagy |
|
IT Directors Group |
Edit Tóthné Hajdu |
|
|
|
|
OTHER EXPERT COMMITTEES |
|
|
HMA |
Dr. Gábor Kulcsár |
|
Coordination Group for MR and Decentralised Procedures – Vet (CMD-V) |
Dr. Dóra Földesi-Lukáts |
|
HMA Quality Manager Working Group |
Dr. Livia Németh-Konda |
|
HMA Working Group of Enforcement Officers |
Dr. János Kovács |
|
|
|
|
DG ENTERPRISE |
|
|
Standing Comittee for Veterinary Medicinal Products |
Dr. Melinda Terényi |
|
Veterinary Pharmaceutical Comittee |
Dr. Melinda Terényi |
|
Notice to Applicants |
Dr. Dóra Földesi-Lukáts |
|
|
|
|
EDQM |
|
|
EP Committee for Veterinary Vaccines (Group 15 V) |
Dr. Ernő Horváth |
|
Official Medicinal Control Laboratories |
Dr. Livia Németh-Konda |
|
VBRN (Veterinary Batch Release Network) Advisory Group |
Dr. Gábor Kulcsár |
|
Biological Standardisation program (BSP) Steering Committee |
Dr. Gábor Kulcsár |
Code of Conduct
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 ${text.getData()}
12</article>
Quality policy
The following has evaluated to null or missing:
==> dateTool [in template "10155#10195#22629" at line 7, column 33]
----
Tip: If the failing expression is known to legally refer to something that's sometimes null or missing, either specify a default value like myOptionalVar!myDefault, or use <#if myOptionalVar??>when-present<#else>when-missing</#if>. (These only cover the last step of the expression; to cover the whole expression, use parenthesis: (myOptionalVar.foo)!myDefault, (myOptionalVar.foo)??
----
----
FTL stack trace ("~" means nesting-related):
- Failed at: #assign publish_date = dateTool.toDat... [in template "10155#10195#22629" at line 7, column 9]
----
1<article class="article-details">
2 <h2>${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 ${text.getData()}
12</article>
Quality defect
The following has evaluated to null or missing:
==> dateTool [in template "10155#10195#22629" at line 7, column 33]
----
Tip: If the failing expression is known to legally refer to something that's sometimes null or missing, either specify a default value like myOptionalVar!myDefault, or use <#if myOptionalVar??>when-present<#else>when-missing</#if>. (These only cover the last step of the expression; to cover the whole expression, use parenthesis: (myOptionalVar.foo)!myDefault, (myOptionalVar.foo)??
----
----
FTL stack trace ("~" means nesting-related):
- Failed at: #assign publish_date = dateTool.toDat... [in template "10155#10195#22629" at line 7, column 9]
----
1<article class="article-details">
2 <h2>${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>
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
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
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.
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.