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Veterinary hygiene biocidal products

2013.06.03. Print
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Product:

Products in this group are used for animal hygiene purposes which get in contact with the animal body, especially disinfectants for skin, mucous membranes, udders, hooves, and impregnated wipes and paper towels used on the animal body.

  • Main Group I: Product type 3. (Veterinary hygiene biocidal products)

Applicable law 

Process description:

  1. Request for the authorisation has to be sent together with the attachments needed to Central Agricultural Office Directorate of Veterinary Medicinal Product (Mezőgazdasági Szakigazgatási Hivatal Központ Állatgyógyászati Termékek Igazgatóságára -MgSzH ÁTI). After issuing the expert’s report, in case of a positive decision, the authorisation will be granted.

  2. The applicant has to register the product within 90 days after placing the product on the market at the National Institute of Chemical Safety (Országos Kémiai Biztonsági Intézet).

  3.  In case of hazardous materials a separate registration has to be made within 90 days after placing the product on the market at the National Institute of Chemical Safety.

I. EXPERT’S REPORT and AUTHORISATION:

Issuer of the Expert’s report and the Authorisation:
Central Agricultural Office Directorate of Veterinary Medicinal Product (MgSzH ÁTI)

Contact Person:
Dr. Györgyi Horváth horvathg@oai.hu,
Phone: 00 36 1 433 0330 extension: 151
Direct phone: 00 36 1 433 0332
Fax: 00 36 1 262 2839

Central Agricultural Office Directorate of Veterinary Medicinal Product (MgSzH ÁTI)
Department for Registration of Medicinal Products (Gyógyszer-törzskönyvezési Osztály)
Address: H-1107 Budapest, X. Szállás u. 8.
www.mgszh.gov.hu

Documents requested for the experts' report:
The application for the authorisation must be submitted in two copies, in Hungarian. The application documentation shall be stapled, provided with a table of contents and numbered pages, and submitted in English or Hungarian. The label and the instructions for use must also be attached in electronic format. The application must be accompanied by a product sample in commercial packaging, and the analytical report issued by the manufacturer and certifying the quality of the sample.
The application documentation for the authorisation of the biocidal product shall contain the following information:

1.      applicant's name, address, contact information (telephone, fax, e-mail address);
2.      a copy of the site authorization for both the manufacturer of the biocidal product and active substance (name, address, phone, fax, e-mail address) and the product manufacturing site;
3.      the trade name of the veterinary biocidal product;
4.      the complete quantitative and qualitative composition, the description of the functions of the ingredients;
5.      the physical, chemical and biological characteristics;
6.      the product type and form, the intended use;
7.      the area of utilization and the range of uses and users;
8.      the method of use and dosage, dose, dilution ratio, time of impact, application methods; for disinfectants: the antimicrobial spectrum, the ventilation or waiting time following the treatment before using the premises again;
9.      for disinfectants: the mode of action, the impact on the target organisms, and the efficacy testing in accordance with current European standards, and the laboratory efficiency tests and the field tests performed depending on the product type;
10.  the results of field tests performed for biocidal products intended for use on the body surface of animals or in the area where the animals are kept, with pest-control purposes against lesser mealworm beetles, red mite and Argasidae sp.
11.  the presentation of the analytical test methods, quality control methods and parameters used;
12.  the classification, packaging, labelling, Hungarian language labels, instructions for use and the final printing samples in accordance with the requirements of the Act on chemical safety, and specific regulations on the detailed rules on certain procedures and activities related to hazardous substances and preparations, and on the production and marketing biocidal products;
13.  the packaging units to be marketed;
14.  the Material Safety Datasheet (in the original language and in Hungarian) of the hazardous biocidal product: Material Safety Datasheet of the hazardous active substances included in the biocidal product, compiled in accordance with the provisions of Regulation 1907/2006/EC, Chapter IV and Annex II;
15.  the storage instructions and the shelf life for the product and its dilution, certified by the stability test;
16.  the warnings related to users and the animals, first-aid regulations, as well as the known antidote;
17.  the toxicological and ecotoxicological test documentation of the preparation,
18.  for udder disinfectants: the certification of TSE requirements of the materials used for their production;
19.  the copies of application documents, labels and instructions for use previously submitted in other Member States,
20.  the material compatibility tests for preparations used on surfaces;
21.  the waste disposal requirements;
22.  the description of the direct and outer packaging;
23.  the residue tests and establishing of the withdrawal period for veterinary drugs, if necessary.

Duration of issuing the expert’s report:
30 days after the administration fee is arrived and the documentation is complete

Administration fee for the expert’s report and the authorisation:
108.000 HUF+ fee of the analytical test

Duration of the authorisation:
22 working days in case of a complete documentation and arriving of the fee after issuing of the expert’s report

III. REGISTRATION:

To register a biocidal product first you have to register yourself at the ÁNTSZ (National Public Health and Medical Officer Service porta, go to: www.antsz.hu/regisztracio

ATTENTION: Foreign companies may also register at the homepage of ÁNTSZ, they are supposed to fill the form as follows:

1. As tax numbers are formatted according to the Hungarian rules on this webpage, so please do not enter here a foreign tax number, rather enter the following number 000000-1-00
(it just shows us that it is a foreign company).

2. Foreign companies should writer Budapest into the city field with postal code 1111.

3. On the bottom of the registration page there is a text box. Foreign applicants should include the data of their companies into this text box.( It has to contain the following data:

Full name of the company

Tax number

Address, in the following structure: Country, Postal code + City, street number

(If any other accessibility data and the responsible person’s name are also given, then these data will be put in the system and you do not have to give them in the partner service box.

4. Based on the above information the company data are entered into the Chemical Safety Information System, (processing time is about one or two days).

User name and password to enter the ÁNTSZ (National Public Health and Medical Officer Service) portal will be sent to the e-mail address given on the registration form.

Required data:

1. Applicant’s:
1.1. name
1.2. office’s address (please specify the county)
1.3. phone number, fax number, e-mail address
2. Responsible person’s:
2.1. name
2.2. address (post address)
2.3. phone number, fax number, e-mail address
3. Name of the biocidal product
4. Main group and Product type of the biocidal product
5. Indicate if the biocidal product will be marketed in more product types (PT). All Product types have to be listed.
6. Authorisation number/Expert’s opinion’s number (only in case these are needed)
7. Name of active substance(s) according to paragraph 8 point 9*
8. CAS or EC number(s) of active substance(s)
9. Exact and detailed composition of the product [name (common name, IUPAC/CA name), CAS-/EC-number, amount]
10. The following statement: „I certify that the biocidal product and the components in the biocidal product fulfil the requirements laid down in the law XXV/2000 for chemical safety (2000. évi XXV. törvény a kémiai biztonságról) and the decree 44/2000. (XII. 27.) EüM rendelet about detailed rules of procedures and activities concerning hazardous substances and materials (a veszélyes anyagokkal és a veszélyes készítményekkel kapcsolatos egyes eljárások, illetve tevékenységek részletes szabályairól szóló 44/2000. (XII. 27.) EüM rendelet).”
11. Date and signature
12. Information that a stamped and addressed envelope has to be attached to the registration

Material Safety Data Sheet has to be attached in Hungarian.

*Name of active substance has to be given as it is classified in the EU register of hazardous materials or (if the name is not stated there) as it is listed in EINECS. In case the active substance is not listed in any of these registers the name of the actives substances has to be given according to the current ISO name (International Organisation for Standardization). In case it is none of the above the material has to be named according to the IUPAC rules.

Administration fee:
Free of charge

Contact person:
Mrs. Istvánné Vándor vandor.istvanne@okbi.antsz.hu
Phone: 00 36 1 476 1180

National Institute of Chemical Safety (Országos Kémiai Biztonsági Intézet)
Department for Registration and Notification of Dangerous Substances and Preparations (Veszélyes Anyagok és Készítmények Bejelentése és Törzskönyvezése Osztály)
H-1097 Budapest, Nagyvárad tér 2.

IV. HAZARDOUS MATERIAL REGISTRATION

Data to be submitted:
In case of hazardous materials please fill in Appendix 5 of the decree 44/2000. (XII. 27.) EüM rendelet. The data has to be submitted in Hungarian.
For English translation please click here.

Administration fee:
9200 HUF

Contact person:
Mrs. Istvánné Vándor vandor.istvanne@okbi.antsz.hu
Phone: 00 36 1 476 1180

National Institute of Chemical Safety (Országos Kémiai Biztonsági Intézet)
Department for Registration and Notification of Dangerous Substances and Preparations (Veszélyes Anyagok és Készítmények Bejelentése és Törzskönyvezése Osztály)
H-1097 Budapest, Nagyvárad tér 2.

National Public Health and Medical Officer Service
www.antsz.hu/en