Procedures to apply for / establish grace periods
Procedures to apply for / establish grace periods
- Application for grace periods
a. In applications for (voluntary) restriction of the use or withdrawal of the authorization, the applicant can state the desired grace periods and the argumentation in the application form WI. Additionally he has to provide a sound explanation why the expiration of the product was or could not be communicated to the supply chain and end users in advance. Lack of timely communication by the applicant on its own is not considered a valid ground for granting grace periods.
b. In order to apply for grace periods, an application for voluntary withdrawal of the product authorization or use may also be submitted when the product authorization is about to expire LINK; e.g.:
i. No product renewal was applied for
ii. Active substance approval expires
iii. Non – renewal of the active substance approval
Such an application must be submitted at the latest 3 months in advance of the scheduled expiration date. Earlier applications (in case the applicant acts pro-actively and takes his responsibility in an early stage) will not be jeopardized by the fact that the applicant shows that he is aware of the expiration and thus the surprise element is less valid. However, again the applicant has to provide a sound argumentation for the need of grace periods in this situation. See also 1a.
c. In case of other applications that normally take longer to evaluate, e.g. applications for extension art. 33, renewal art 43, etc. lead to a restriction of the WG, the applicant will be contacted by the project manager in the finalizing stages of the concept decision. The applicant should then submit his desired grace period and argumentation tuned to the actual situation within a few working days.
- The project manager prepares a proposal for grace periods to the Board. In this proposal the following elements and principles are balanced against one another to determine whether grace periods can be allowed and for how long:
a. Length of grace periods desired by the applicant + argumentation.
i. Timing of the decision relative to the application season
ii. Amount of stocks in the market and with the end user – costs of removal or relabelling for the producer and end user.
iii. Surprise element
iv. Lack of alternatives for the end user
v. Other arguments from the applicant
In case the applicant does not apply for grace periods, they will be set to zero, even if there is no risk involved.
b. The maximum grace periods of 6 months for distribution and additionally 12 months for use, or otherwise if stated so in an EC regulation relevant for the specific product.
c. Only in case the restriction of the label is not linked to a risk for humans, animals or environment the maximum grace periods may be approved.
d. Severity of risk triggering the restriction of the use. In case of proven or highly unacceptable acute risk for humans, animals or environment, the grace period will be minimized or zero. In most cases risk cannot be excluded because of lack of data but is not proven; in that case there may be more room for grace periods, but the maximum grace period for use is usually not proposed. Risks for various aspects identified within one decision may add up together. The project manager may ask for expert judgement from the Ctgb experts. The severity of the risk may also be derived from the EU Active Substance evaluation or a recent evaluation of similar products.
e. Risk permitting, the proposed grace period will cover use in the current application season or in the upcoming application season in case the decision is taken in a period that the product is not being used. The GAP is leading to determine the application season, and for year round greenhouse uses, the season is considered to run from January 1 to December 31 in the same year. However, a grace period for sales and distribution is limited to a maximum of 6 months and consequently may not reach to the end of the current or a new application season.
f. Risk permitting, to avoid need for removal and destruction of remaining stocks.
g. The history and duration of the product authorization.
h. Grace periods issued for similar products.
i. Whether or not other authorizations with a similar use are on the market and may still be used without the new restrictions.
- As a standard process, the proposed grace periods will be peer reviewed within the Ctgb secretariat to guard consistency of the proposals.
- The Board will consider the balancing of factors set out above for her decision on the proposed grace periods and may change the proposed grace periods for the approved final decision.
- A concise argumentation for the length of the grace periods will be included in the Dutch text of the Board decision. In appendix I of the decision the grace periods and applicable W-code versions of the WG are specified with end dates under: ‘Toelatingsinformatie’.
- After the final Board decision is signed and published the grace periods will be specified for each WG version in the Ctgb database.
Important warning for authorizations under re-evaluation; reregistration or renewal – grace period for sales may not be effective
Practice learns that a re-evaluation of an existing authorization often leads to restriction of the label in one or more aspects. This means that a new version of the WG will be established upon the Board decision and grace periods apply to the current version of the WG. Applicants are advised not to produce huge amounts of labelled stocks of such products during the re-evaluation, especially if the application is bound to a short season. Also holders of derived trade permits or parallel trade permits have to consider this. Authorization holders run the risk that at the date the decision enters into force, even a maximum grace period for distribution of 6 months will not reach to the next application season. When faced with the dilemma of having to produce new stocks for the upcoming season while the Board decision is expected within a short time frame, applicants are advised to contact the project manager in charge of the re-evaluation. However, Ctgb is bound to take decisions as soon as the re-evaluation is ready and is bound to the maximum grace period for distribution of 6 months.