Post Annex I. Period

Procedure of post Annex I product authorisation and mutual recognition

The picture below shows a chronological figure on the example of sulfuril fluoride and serves for a better understanding of the procedure:

Active substance and Product

1.) Voting at Standing Committee

2.) Coming into force of the amendment Directive of 98/8/EC (in this case for sulfuril fluoride)

3.) Inclusion of the active substance (deadline for the submission of first product authorisation and letter of intent for mutual recognition)

4.) Authorisations to be granted, modified or cancelled.

For Annex I and IA inclusions, click here.

For phasing out of active substances and products, click here.

According to the regulation 38/2003 (VII.7.) ESzCsM-FVM-KvVMthe Hungarian Competent Authority requires the following:

I. For the first authorisation:

• Covering letter stating that the applicant would like to apply for product authorisation.

• One electronic copy of the dossier as stated in the BPD, accepted in Hungarian or English OR letter of access.
  For union level authorisation of biocidal products you can get detailed information of documentation to be handed in, following the bellow link: http://ihcp.jrc.ec.europa.eu/our_activities/health-env/risk_assessment_of_Biocides/guidance-documents . You will get a clear line on the data requirements and information of the subject-matter and outlook of the documentation if you follow the recommendations on this page under point 1. and 5. In case you are in possession of a Letter of Access regarding the active substance, you only have to follow the information concerning the product authorisation (Part B). To prepare a documentation for product authorisation further useful information can be found on this page.

• Fee for product authorisation has to be paid according to our fee regulation 1/2009. (I.30.) EüM rendelet.

II. Mutual recognition of the first authorisation:

1. In the first step the following is required:

• A covering letter confirming that an application is made for mutual recognition of authorisation for the product
• A filled in paper copy of the application form generated via R4BP. Hungarian version is preferred.
• Letter of Access to active substance Annex I. listing data package.
• One electronic copy of the summary dossier for the product as submitted to the first Member State, OR Letter of Access

2. In the second step of mutual recognition the following is required:

• Covering letter that the first authorisation has been granted.
• Certified copy of the first authorisation granted in the Reference Member State. Certified Hungarian translation is required if it is not in English.
• Fee for mutual recognition has to be paid according to the fee regulation 1/2009 (I.30.) EüM rendelet.
• One electronic and one paper copy of the Assessment Report.
• One paper copy of the summary dossier for the product as submitted to the first Member State.
• Label proposal, Safety Data Sheet and using instructions are only accepted in Hungarian.

You are also advised that based on the requirements of the European Commission, DG Environment, the first part of your application be submitted via the European Register for Biocidal Products (R4BP) which is available on the European Commission´s web-site https://webgate.ec.europa.eu/env/r4bp/ . Using the said Register please indicate also your potential interest in having the product placed on the market in other EU Member States based on mutual recognition.
If necessary, please consult any question related to R4BP applications directly with Mr. Pierre Choraine Pierre.Choraine@ec.europa.eu or with the administrator ENV-R4BP-BIOCIDAL-REGISTER@ec.europa.eu.

According the above mentioned fee regulation (1/2009. (I.30.) EüM rendelet.) fees are the following:

§   Product authorisation: 2 500 000 HUF~ 9400 EUR

§   Product registration: 1 250 000 HUF~ 4700 EUR

§   Mutual recognition of PA: 500 000 HUF ~1890 EUR

§   Mutual recognition of PR: 250 000 HUF ~940 EUR

(The fee in EUR depends of the HUF/EUR rates)

The fee without the bank transfer costs should be transferred as follows:

The transfer has to be made to the bank account of the Országos Tisztifőorvosi Hivatal (Office of the Chief Medical Officer of State).

IBAN: HU81 10032000-00281519-00000000.

Our main bank is Magyar Államkincstár (Hungarian State Treasury), (1139 Budapest, Váci út 71.);

SWIFT code: MANEHUHB.

Please specify the treasury transfer code 300 and give the name of the biocidal product in the comments.

For the invoice your EU tax number and company address is needed which have to be specified in the cover letter.

The documents must be sent to the following address:

Dr. Márta Kovács
Head of Public Health Department

National Public Health and Medical Officer's Service
Office of the Chief Medical Officer of State
(Állami Népegészségügyi és Tisztiorvosi Szolgálat, Országos Tisztifőorvosi Hivatal)
H-1097 Budapest
Albert Flórián u. 2-6