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Products used against health pests

2013.04.25. Print
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wProduct:

Insecticides, acaricides and other products used for the control of health pests.

  • Main Group III. Product Type 18. (Insecticides, acaricides and products to control other arthropods)

Applicable law:

Process description:

  1. a.) 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, Albert Flórián út 2-6.) and the application for the expert’s report (addressed to Dr. Judit Szlobodnyik) together with the requested attachments should be sent to the following address:

    National Center for Epidemiology (Országos Epidemiológiai Központ)
    Department of vector and public health pest control
    H-1097 Budapest, Albert Flórián út 2-6.
    Hungary

    b.) The National Center for Epidemiology requests, if it is needed, additional documents then considers the documentation and performs efficacy tests.

  2. Expert’s report, which means a suggestion for authorisation of the product, 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)

Contact person:
Dr. Judit Szlobodnyik szlobodnyik.judit@oek.antsz.hu
Phone:    00 36 1 476 1294  

National Center for Epidemiology (Országos Epidemiológiai Központ)
Department of vector and public health pest control (Dezinszekciós és deratizációs osztály)
1097 Budapest, Albert Flórián út 2-6.

Documents requested for the experts' report: 

  1. Name of the product

  2. Exact composition (Confidential Statement of Formula) of the product (with chemical name, CAS and EINECS number of each component (100 %))

  3. Name and address of the applicant (which is the Hungarian distributor of the product with company seat in Hungary)

  4. Name and address of the manufacturer

  5. Material Safety Data Sheet of the active substance(s) and other component(s) in original language from the manufacturer

  6. Material Safety Data Sheet of the product in original language from the manufacturer

  7. Material Safety Data Sheet of the product in Hungarian

  8. Shelf life of the product

  9. Filling mass or filling volume per packaging(s) (g or ml)

  10. Form and material(s) of packaging(s)

  11. Storage conditions

  12. Documentation of the biological efficacy on target organisms, especially of the duration of efficacy (e.g. weeks or months of the insecticide activity – for PCO spraying concentrates, CIK aerosols and sprays)

  13. In case of a foreign product original Using Instruction

  14. Hungarian draft Using Instruction

  15. In case of a foreign product a sample is needed (quantity depends on the features of the product) for performing efficacy tests

  16. A statement from the manufacturer that the applicant has a right to distribute the product in Hungary and use the name of it

Duration of issuing the expert’s report:
Depending on the laboratory tests according to the product properties and area of use.

Administration fee for the expert’s report:
333.500 HUF (according to the fee regulation 1/2009. (I.30.) EüM)

II. AUTHORISATION:

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

 (Országos Tisztifőorvosi Hivatal)

Contact Person:
Ms Ágnes Szabó szabo.agnes@oth.antsz.hu
Phone: 00 36 1 476 1351
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, Albert Flórián út 2-6.

Administration fee: 
96000 HUF (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