1. Handling the “stop of the clock” in product authorisation
Background:
Agreed actions list in Sept to minimise delays in PA:
“6. ECHA/COM: monitor delays, particularly in refMSs”
Detailed reports by ECHA at CG-21 (January 2017): significant delays before the refMS releases the PAR for MR
Several reasons, but most important are:
- Content of the dossier and
Handling of the “stop of the clock” provision:
Requirement of additional information,
Delays by applicants when submitting that information,
Time needed to assess the submitted information,
 In some cases, the above-mentioned "process" is repeated several times until an acceptable outcome is found.

2. Handling the “stop of the clock” in product authorisation
Background:
Need to take action, in order to:
- Identify any technical or regulatory issues arising from the assessment of the applications by different evaluating bodies at the same time
4. refMSs: early identify any emerging issue and to refer it to the relevant EU fora
5. ECHA/MSs: ensure assistance in WGs to product authorisation issues
- Make the product authorisation process more efficient and allow all MSs (or COM) to deliver the product authorisations within the three-year period referred to in Article 89(3) of the BPR.

3. Handling the “stop of the clock” in product authorisation:
MRP
Existing products under the transitional rules (Article 89(2) – 3 years)
Application for PA
Products authorised under the BPR
“confort zone”
Validation up to 5 months ( days)
MR + NA up to 9 months
MR: 90 d
CG: 60 d
COM dec: +/-90 d
NA: 30 d
Evaluation by refMS (365 + up to 180 days)

4. Handling the “stop of the clock” in product authorisation:UA
Existing products under the transitional rules (Article 89(2) – 3 years)
Application for PA
Products authorised under the BPR
“confort zone”
Validation up to 5 months ( days)
Peer review BPC (270 days)
Evaluation by refMS (365 + up to 180 days)
UA by COM
(120 d left!)

5. Handling the “stop of the clock” in product authorisation:
MR-P or UA
Existing products under the transitional rules (Article 89(2) – 3 years)
Validation up to 5 months ( days)
Application for PA
Evaluation (365 + > 180 days)

6. Handling the “stop of the clock” in product authorisation:
MR-P or UA
Existing products under the transitional rules (Article 89(2) – 3 years)
Validation up to 5 months ( days)
MR + NA or UA
Products authorised under the BPR
“concern zone”
Application for PA
Evaluation (365 + > 180 days)

7. Handling the “stop of the clock” in product authorisation:
MR-P or UA
Existing products under the transitional rules (Article 89(2) – 3 years)
Evaluation + “stop(s) of the clock”
MR + NA or peer review + UA
E- body 1
E- body 2
E- body 3
E- body 4
E- body 5
Identification of technical or regulatory issues

8. Handling the “stop of the clock” in product authorisation:
MR-P or UA
Existing products under the transitional rules (Article 89(2) – 3 years)
Evaluation + “stop of the clock”
MR + NA or peer review + UA
Products authorised under the BPR
“confort zone”
E- body 1
E- body 2
E- body 3
Consistency between e-CAs
Harmonised approach for all products
Less MR disagreements
E- body 4
E- body 5
Send “list of all questions” to the applicants
Identification of technical or regulatory issues for CG/WGs in time