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Surface or airspace disinfectant products for veterinary purposes

2013.04.25. Print
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Product:

Products in this group are used for surface or airspace disinfection.

Authorisation and registration of these products are required.

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

Applicable law:

Process description:

  1. The application for authorisation (which should be addressed to: Dr. Lajos Ócsai, Head of Department; Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal); Department of Epidemiology (Járványügyi Főosztály); 1097 Budapest, Gyáli út 2-6.) and the application for the expert’s report together with the requested attachments should be sent to the following address:

    Dr. Márta Melles
    Director General
    National Center for Epidemiology (Országos Epidemiológiai Központ)
    H-1097 Budapest, Gyáli út 2-6.
    Hungary

  2. a.) National Center for Epidemiology coordinates the procedure for giving the expert’s report and asks for a veterinary expert's report in case of surface or airspace disinfectants used near animals’ housing places from the Central Agricultural Office Directorate of Veterinary Medicinal Product (MgSzHK ÁTI). Two copies have to be submitted for every document.

    b.) Expert’s report together with the attachments will be forwarded automatically to the Office of the Chief Medical Officer of State for authorisation. The latter sends a request to the applicant for paying the administrational fee. Authorisation can only be given after the payment of the fee.

  3. 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).

  4. 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:

Issuer of the expert’s report:
National Center for Epidemiology (Országos Epidemiológiai Központ-OEK)

Contact point:

 

National Center for Epidemiology (Országos Epidemiológiai Központ),
Department of Disinfection 
(Dezinfekciós osztály)

Head of the Department: Dr. Márta Milassin
Staff members:
Ms. Ildikó Auer
Ms. Andrea Domokos
Ms. Tünde Takács
Ms. Pálma Cserháti

Adress: H-1097 Budapest, Gyáli út 2-6. Hungary
Centrel phone number: 36 1 476 1100 extension: 2104
Direct phone number: 36 1 476 1367
Fax: 36 1 476 1367

Contact Person (MgSzH ÁTI):
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 (Mezőgazdasági Szakigazgatási Hivatal Központ Állatgyógyászati Termékek Igazgatósága)
Department for Registration of Medicinal Products (Gyógyszer-törzskönyvezési Osztály)
H-1107 Budapest, X. Szállás u. 8.

Documents requested for the experts' report:

  1. Data of the manufacturer of the disinfectant product (name, address, contact person)

  2. Data of the Hungarian distributor of the disinfectant product (name, address, contact person)

  3. Material Safety Data Sheet of the disinfectant product (Hungarian MSDS is needed in case of a foreign product)

  4. Full composition of the biocidal product, name of the active substance(s), CAS- or EC-number, description about the functions of the components

  5. Material Safety Data Sheet of each component

  6. Warranty period of the disinfectant product, utilization time of the solution for work

  7. Information on units of distribution

  8. Information on packaging

  9. Tests (made according to Euronorm standards) reports of an accredited laboratory, which is independent from the manufacturer which confirm the antimicrobial effect

  10. Documentation of toxicological and ecotoxicological studies

  11. Authorisations issued by other countries

  12. Incompatibility tests

  13. Hungarian draft label/Hungarian using instructions (in case of a foreign manufactured product the original label is needed, as well), proposed area of use

  14. Sample of the products for performing tests

  15. List of quality control methods

  16.  In case of a product for disinfection of animal housing places, please give the duration of the time which is needed to readmit the animals into the disinfected area.


Duration of issuing the expert’s report:
MgSzHK ÁTI: 30 days for the veterinary expert’s report after arriving of the administration fee in case of a complete documentation.
OEK: 30 days after the administration fee is arrived and the documentation is complete, and the veterinary expert’s report has arrived.

Administration fee for the expert’s report:
MgSzHK ÁTI: 30.000 Ft + fee of the analitical test
OEK: 40.000 HUF + 25% VAT/product

II. AUTHORIZATION:

Issuer of the authorisation:
Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal)

Contact Person:
Mr. Béla Gergely gergely.bela@oth.antsz.hu
Phone:    00 36 1 476 1222 
Fax: 00 36 1 215 5311

Office of the Chief Medical Officer of State (Országos Tisztifőorvosi Hivatal)
Department of Epidemiology (Járványügyi Főosztály)
H-1097 Budapest, Gyáli út 2-6.

Administration fee: 
96000 Ft (according to the fee regulation 1/2009. (I.30.) EüM)

Duration of the authorisation:
22 working days in case of a complete documentation and arriving of the fee

III. REGISTRATION:

If the product requires authorisation during transitional period, following the authorisation process, OCMO notifies the product in question to the National Institute of Chemical Safety (NICS).

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

In case the biocidal product or active substance is classified as hazardous, and the biocidal product requires authorisation, following the authorisation process, OCMO notifies the product in question to NICS.

Regarding the notified data as well as concerning missing administration fee NICS is the assigned authority. In these cases staff members of NICS contacts the applicant.

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