Go to content

Requirements for administrative extension around Renewals

In practice the date of expiry of active substances is often postponed by the EC. Therefore, PPP authorizations may need to be extended accordingly, as renewal applications cannot yet be submitted. Also, once an application is submitted, PPPR (EC) 1107/2009, Article 43.6 states that Member States can issue extensions for the current authorization in case the reason for delay in the evaluation process is beyond control of the authorization holder/applicant.

Monitoring the expiry dates and timely action to prevent unintended expiration is the explicit responsibility of the authorization holder. So in case applicants are not sure, please contact the Ctgb Service Desk or the Ctgb project manager assigned to the specific PPP renewal application. Be aware that in case a product contains more than 1 active substance, the first active substance to expire or (to be) renewed triggers the expiration date for the PPP authorization.

See also the basic information about our policy on administrative extensions.

For product authorizations that are not in line with the AS expiry dates or in case renewal applications cannot be finished before the deadline of Date of Application (DoA)  + 12 months, additional information is given in the table below.

 

In case

Action
1.

Product authorization expires before DoA + 12 months

  • AS renewal is positively decided on but DoA + 12 months is in the future
  • AS renewal is ongoing and not yet decided on
  • AS renewal is ongoing and AS date of expiry is postponed

Ctgb will extend the date of expiry of the product authorization in line with:
-    the (new) date of expiry - in case the active substance renewal is ongoing
-    or DoA  - in case the active substance renewal regulation has already been decided on
of the active substance + 12 months (article 32 of PPPR (EC) 1107/2009).
No application nor notification is required as a prerequisite*.
2.

An application for art 43 PPP renewal was submitted in time, but cannot be finished before DoA + 12 months. Valid reasons are:

  • agreed delay of the submission of the dRR to the deadline applicable for the second active substance because the renewal of two active substance in the product is expected within 1 year.
  • confirmed approval of delay for the submission of category 4 studies and the dRR by the zRMS or Ctgb as zRMS.
  • delays in the evaluation process caused by the zRMS or Ctgb (as zRMS or cMS).
 Ctgb will extend the PPP authorization for the period estimated to be needed to complete the evaluation,  on the condition that the delay is beyond the control of the applicant (art 43.6 of PPPR (EU) 1107/2009).
3. Non-renewal; the EC has taken a negative decision on the renewal of the active substance, but the product authorization expires before the confirmed date of expiry of the active substance set in the non-renewal regulation.

The product authorization can be extended to maximum the confirmed date of expiry of the active substance approval or if applicable the date specified in the non-renewal regulation for expiry of products based on that active substance*.

Article 32 of PPPR (EC) 1107/2009 does not apply in these cases. As the approval of the active substance is terminated, the conditions set in article 29 sub 1a are no longer fulfilled.
4.

It is confirmed that the active substance approval is not going to be renewed and the product authorization expires before the confirmed date of expiry of the active substance:

  • No renewal applied for – original AS date of expiry stands
  • Renewal aborted – original date of AS expiry stands or in case it was already postponed, the EC may set a new AS date of expiry.

The product authorization can be extended to maximum the confirmed date of expiry of the active substance approval*.

Article 32 of PPPR (EC) 1107/2009 does not apply in these cases. As the approval of the active substance is terminated, the conditions set in article 29 sub 1a are no longer fulfilled, and according to article 44 sub 3 product applications should be terminated on the same date as the active substance approval.

* In case a PPP authorization cannot be renewed (active substance approval expires) or no application for renewal was received before DoA + 3 months and the authorization expires close to the deadlines set out above,  Ctgb may actively approach authorization holders with the question whether they agree with the scheduled expiration date or an administrative extension is required.