Commentaries: Art. 19

Subject to receipt of the advance on costs, the Notification Authority shall take a decision, without undue delay and at the latest within the following time limits, on:

a. validation of an application for authorisation ALor AnL:	30 days
b. validation of an application for recognition:	30 days
c. validation of additional information for an application for authorisation ALor AnL:	30 days
d. evaluation of an application for authorisation AL:	365 days
e. evaluation of an application for authorisation AnL:	550 days
f. evaluation of an application for recognition:	90 days
g. evaluation of an application for recognition in accordance with Article 34 of Regulation (EU) No 528/2012¹after receipt of the draft assessment report from the reference Member State:	120 days
h. evaluation of an application for simplified authorisation:	90 days
i. evaluation of an application for authorisation for parallel trade:	60 days
j. evaluation of an application for authorisation AN:	60 days
k. assessment of whether, for the renewal of an authorisation ALor AnL, a full evaluation as specified in Article 26 paragraph 5 is required:	90 days
l. full evaluation for the renewal of an authorisation ALor AnL:	365 days
m. non-full evaluation for the renewal of an authorisation ALor AnL:	180 days

For biocidal products for which authorisation is not required, as specified in Article 3 paragraph 3, the Notification Authority shall, if necessary, issue an opinion within the following time limits:

a. biocidal products authorised under a simplified procedure in an EU or EFTA Member State:	30 days
b. biocidal products within an authorised biocidal product family:	30 days
c. biocidal products released for purposes of research and development:	45 days

If the Notification Authority asks for additional documents, the time limit «clock» shall be stopped until the additional information has been submitted. Altogether, the clock shall be stopped for no more than 180 days, unless a longer period is justified on account of the type of additional information requested or exceptional circumstances.
The FDHA may, in consultation with DETEC and the EAER, specify further time limits for processing. Otherwise, the limits specified in the Ordinance of 25 May 2011²on Principles and Time Limits for Authorisation Procedures apply.

Art. 19