Central Institute for Supervising and Testing in Agriculture

The Institute performs the administration and carries out some other administrative activities, expert and testing tasks and control and monitoring activities in accordance with special acts in the areas of plant variety testing, feedingstuffs, agrochemical testing of soils, soils and plant nutrition, seeds and seedlings of the grown plants, perennial plants (viniculture and hops), protection against harmful organisms and plant protection.

News in process of authorising of PPPs after 1 July 2023

27. 4. 2023

On 1 July 2023, an amendment to Act No. 326/2004 Coll., on Phytosanitary Care, as amended, will enter into effect and bring changes related to the process of authorising plant protection products (PPPs).

This information provides an overview of the most significant changes that will affect applicants for or holders of authorisations of PPPs and it is recommended to pay special attention to them:

1. Amendment and withdrawal of authorisation

New letters f) and g) have been added to Article 35(1), which impose on the Central Institute for Supervising and Testing in Agriculture (ÚKZÚZ) the obligation to withdraw the authorisation of PPP in the following cases:

f) the decision on the authorisation of the product is valid, but the approval of the active substance has expired and there is no ongoing procedure for renewal of approval of the active substance or renewal of authorisation of PPP, or

g) the approval of the active substance of PPP has been renewed, but the application for the related renewal of the authorisation of PPP and related documentation has not been submitted by the applicant within the deadline set by the directly applicable European Union regulation on placing PPP on the market.

Particularly important for the authorisation holder is the new letter g), which emphasizes the obligation of the authorisation holder to submit an application for renewal of the authorisation of all plant protection products placed on the market in the Czech Republic within the set deadline. In this case, the authorisation holder IS REQUIRED TO submit an application for renewal of the authorisation of a PPP in accordance with Article 43(2) of Regulation (EC) No. 1107/2009, NO LATER THAN 3 months after the entry into effect of the European Commission’s regulation renewing the approval of the active substance. If the authorisation holder fails to do so, an ex officio procedure will be initiated by ÚKZÚZ to withdraw the authorisation of the PPP. The decision on the withdrawal of the authorisation will include deadlines for the sale and use of existing stocks of PPP in accordance with Article 46 of Regulation (EC) No. 1107/2009.

The holders of PPP authorisations are reminded that from the date of entry into effect of the Regulation on the renewal of approval of the active substance, it will be NO LONGER POSSIBLE, due to the wording of Article 35(1)(g) of Act No. 326/2004, to authorise another trade name for a product containing an active substance whose approval has been renewed, until the decision on the renewal of the authorisation of the reference product, from which the other trade name is to be derived.

2. Mutual recognition of authorisations

As from 1 July 2023, the applicant is NO LONGER REQUIRED to submit a binding opinion of the Ministry of Health based on the evaluation carried out by the National Institute of Public Health in the procedure for the application for mutual recognition of a plant protection product. This applies both to the authorisation of a new PPP and to amendments to an existing authorisation carried by way of mutual recognition of authorisations.

After 1 July 2023, the applicant shall submit an application for authorisation of a PPP only to ÚKZÚZ. There will be no further changes in the existing procedure of ÚKZÚZ for mutual recognition of authorisations after the entry into effect of the amended Act.

In proceedings for mutual recognition of authorisations of a PPP or amendments to an existing authorisation by way of mutual recognition initiated and not completed before 1 July 2023, for which a binding opinion of the Ministry of Health is required, ÚKZÚZ shall proceed as follows:

if the applicant submits an application for mutual recognition of authorisations to the National Institute of Public Health by 30 June 2023, it is necessary to provide the binding opinion issued by the Ministry of Health and ÚKZÚZ will take its wording and conclusions into account in the decision issued, even if the decision is issued after 1 July 2023.

if the applicant submits an application for mutual recognition of authorisations after
1 July 2023, there is no longer a need to provide a binding opinion of the Ministry of Health.