01.01.2016 - When the Ordinance on Fees for Therapeutic Products (HGebV, SR 812.214.5) came into force on 1 January 2013, it introduced a procedure with prior notification (PPN).
The purpose of the PPN is to enable applicants to notify their submission date at an early stage, so that Swissmedic can in turn plan as accurately as possible and in advance the necessary human resources required and draw up a streamlined and precise schedule for the review. The 20% faster processing time and fixed planning offered by this procedure are subject to a fee surcharge of 100%.
Following a two-year pilot phase (2013 – 2014), 2015 was used to collate, evaluate and exchange the experience gained with this procedure by industry and Swissmedic. One of the platforms for these activities was a joint workshop held in April 2015. The focus was on shortening the time frame for requests, the possibility of switching flexibly between the fast-track procedure and the PPN, earlier review of relevant sections of the information for healthcare professionals and appropriate remuneration of the effort expended by Swissmedic. Swissmedic subsequently defined several measures designed to make the procedure more attractive in the future, to facilitate planning by the applicant and by Swissmedic and to ensure appropriate remuneration.
The PPN will be modified as follows with effect from 1 January 2016:
- The prior notification period for a request for a PPN will be shortened from between 8 and 5 months before planned submission to between 6 and 3 months beforehand.
- Companies can request a PPN directly when submitting an application for a fast-track procedure. If the application for a fast-track procedure is rejected, a PPN could be started for the application at the agreed time.
- In a PPN, the corrected packaging materials and the corrections to the information for healthcare professionals under the four headings: 4. Indications/Uses, 5. Dosage / Administration, 6. Contraindications and 7. Warnings and precautions can be sent to applicants with the List of Questions (LoQ).
- Medicinal products with orphan drug status (ODS) cannot be pre-notified for a PPN or reviewed using this procedure.
The following features of the PPN will not be changed:
- Requests for a PPN will remain free of charge.
- Swissmedic can issue a negative response to a request for a PPN if the conditions are not fulfilled (e.g. lack of personnel).
- Evaluation phase II will not be shortened and will continue to last 90 calendar days (as in the "standard procedure").
- The PPN will not be incorporated into the Therapeutic Products Ordinance (TPO, SR 812.212.21).
- The PPN will not be extended to other types of application. It may be used for:
First approvals of human medicinal products with new active substances (NAS) and additional indications for human medicinal products that were originally approved as NAS.
- As is already being done, Swissmedic will start the corresponding review phases as soon as the responses from the company have been received as announced.
- Additional time may also be charged for a PPN, including time charged for additional effort (as stipulated in the Administrative Ordinance on Deadlines for Authorisation Applications).
- The response deadlines of 90 days after the LoQ and preliminary notification are maximum periods and as such cannot be extended in a PPN.
- Preclinical and clinical trials should be completed by the time the application is submitted. Subsequent submission of additional trial data, results or other documents relevant for the evaluation will delay the process.