Possible consequences of delayed payment in case of renewal applications
Ctgb uses the term formal registration date when both the application with essential submission documents and the application fee have been received by Ctgb. Ctgb’s general policy is that legal timelines only start at the formal registration date and that no work will be done until that time. This also applies to art 43 applications for renewal of product registrations. Applicants should be aware that in case payment of the application fee takes longer than the standard 2 weeks payment term, this not only delays the evaluation of the application itself, but also may jeopardize the legal grounds for an administrative extension under article 43.6.
Generally within 1 to 2 weeks after the application is received, Ctgb will invoice the application fee. The standard payment terms are 2 weeks. So in general the payment can be arranged within 1 month after submitting the application. Applicants are advised to budgetize for paying the application fee and further costs, with help of the Ctgb tariffs Decree.
Applicants generally benefit from timely payment of the application fee, as the application will then be released for intake and evaluation. However, for article 43 renewal applications, it is extra important to pay the application fee in time, as legal time lines are relatively short; 6 months for the Core evaluation and additionally 3 months for the CMSs. Moreover, the current authorization expires 12 months after the Date of Application stated in the EU renewal regulation for the active substance.
Article 43.6 of (EU) 1107/2009 states that member states may administratively extend the current authorization in case the evaluation takes more than the 6 (+ 3) months, but only on the condition that the delay is beyond control of the applicant. Applicants should be aware that in case payment of the application fee takes longer than the standard 2 weeks payment term, this not only delays the evaluation of the application itself, but also may jeopardize the legal grounds for an administrative extension under article 43.6. So applicants for article 43 renewal applications are strongly advised to fulfil the invoice within the 2 week payment term and in case this deadline cannot be met, to actively contact Ctgb to agree on a (short) extension of the payment deadline.