National procedure

Application

Product samples (Swedish)

A validation period of 14 calendar days starts when the application has been submitted. The application is checked in and the Swedish Medical Products Agency (Swedish MPA) verifies that the application is complete to enable start of the procedure.

Procedure

The procedure is divided into three rounds, with a total processing time of 210 calendar days.

Round 1

Once the application is valid, the procedure starts with day 0.

The primary assessment is completed at day 110 and the Swedish MPA send a request for supplementary information to the applicant. The response deadline is 90 days.

The applicant’s first response will be their principal response. With this response, new and comprehensive data can be included. The response deadline of 90 days must be observed. In case no response is received within the stipulated timeframe, a decision on the application may be taken by the Swedish MPA.

An extended response deadline can only be approved under exceptional circumstances provided that the request for extension has been received sufficiently in advance of the specified response date.

Round 2

The procedure is restarted when a complete response has been submitted. This is considered day 111. Responses submitted to the Swedish MPA must be complete - partial responses submitted separately at different times are not accepted. Responses are assumed to be complete and consequently a new round is started when the responses have been received.

The secondary assessment is completed at day 165. If the application cannot be approved, the Swedish MPA send a request for supplementary information to the applicant. The response deadline is 40 days.

The applicant’s second response shall only contain replies to questions together with clarifications - new comprehensive data is not accepted at this stage. The principle is the same as applied in the decentralised and centralised procedures.

Round 3

The procedure is restarted when a complete response has been submitted. This is considered day 166.

If the application still cannot be approved at day 190 after the tertiary assessment:

• the Swedish MPA send a notice of impending rejection, upon which the company is given the opportunity to withdraw the application, or
• communicates the outstanding issues to the applicant.

The applicant is expected to reply promptly to any outstanding issues that may remain during the third round. All outstanding issues must be resolved no later than by day 195 in order to enable approval by day 210.

No further round with an extended response deadline will be granted. After day 195, the Swedish MPA prepares the decision, which is sent by day 210.

If final labelling is not agreed by day 195, the approval can be issued without final labelling. In that case, the approval is conditional so that marketing may only take place once the labelling is approved.

Rejection

The assessment of the Swedish Medical Products Agency must be well-founded in order to guarantee that the requirements of quality, efficacy and safety are demonstrated.

A medicinal product is authorised in Sweden if the applicant’s documentation fulfils the requirements in respect to pharmaceutical quality, safety and efficacy.

An application for marketing authorisation can be rejected if there exists, for example:

• negative benefit risk balance
• insufficient documentation regarding GxP
• insufficient qualification of impurity levels
• substandard analysis methods
• deficiencies in process validation

During the assessment the applicant can submit supplementary information to outstanding questions in the assessment report. If the supplementary information is not deemed sufficient or has not been submitted on time, the application may be rejected.

In case of refusal, a Public Assessment Report (PAR) is published, describing briefly the reasons for refusal: