National applications for authorisation in Sweden

During 2010 the Medical Products Agency changed the procedure for national applications for authorisation of medicinal products, which places greater demands on both the authority and the applying company. The timetable has been revised and the number of possible response rounds has been reduced, whereby the national procedure follows the model for a decentralised procedure to a greater extent than before. This enables faster processing by the Medical Products Agency, but also means that companies have less time than before to complete their applications while processing is in progress.

New timetable

The processing of national applications is divided into three rounds, with a total processing time of 210 calendar days. The Medical Products Agency applies a validation period of 14 calendar days for the check-in of the application and to verify that it is complete. This period may be extended if any complementary information is not received within the validation period.

Overview of the timetable

Round 1
Day 0 Start of procedure when application is validated and complete
Day 110 Primary assessment complete, request for complementary information
response deadline 90 days

Round 2
Day 111 Resumption when complete response received
Day 165 Secondary assessment complete, injunction with request for complementary information to the applicant if the application cannot be approved
response deadline 40 days

Round 3
Day 166 Resumption when complete response received
Day 190 Tertiary assessment complete, notice of impending rejection or communication on outstanding issues to the applicant if the application cannot be approved
Day 195 Outstanding issues resolved, if the application can be approved
Day 210 Preparation of decision complete, decision sent

How the timetable works

Applying companies are given the opportunity for a principal response following the primary assessment, in which new and comprehensive data can be included. The response deadline of 90 days must be observed, and if the response has not been received in time then the case can be decided anyway. An extended response deadline can only be approved in case of exceptional circumstances and where the request for extension has been received in good time before the specified response date. The response to the secondary assessment shall only contain replies to questions together with clarifications, and not new, comprehensive data. The principle is the same as that applied to the decentralised and centralised procedure. Responses received 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.
During the third round, all outstanding issues must be resolved no later than by day 195 in order to enable approval by day 210. In the event that there are any issues outstanding on day 190 the company is expected to reply promptly. No opportunity is granted for a further round with an extended response deadline.
For applications that cannot be approved by day 190, a notice of impending rejection is sent, upon which the company is given the opportunity to withdraw the application.
If final labelling is not agreed by day 195 then the approval can be issued without final labelling. The approval is then conditional so that marketing may only take place once the labelling is approved.  
This page is updated continuously with any changes.

Decision documents

  • Transition to electronic documents. Decisions granting authorisations may be sent in electronic form. In these cases the electronic document replaces a decision on paper.  
  • A decision granting an authorisation is not signed. Decisions on new authorisations, including parallel imports, changes in product information and renewals that are fully in accordance with the aims of the applicant will not be signed by hand. To avoid the lack of a signature leading to the validity of a decision being questioned, the following information will be included in all decisions: ”The decision document does not include the decision-maker’s signature. This does not affect the validity of the decision”.
  • Decisions rejecting applications (full or partial rejection) will continuosly be sent on paper and be signed by the decision-maker.

Refusal

The Medical Products Agency’s assessment must be well-founded in order to guarantee that the requirements of quality, efficacy and safety are demonstrated. A medicinal product is authorized in Sweden if the applicant’s documentation fullfils the requirements in respect to pharmaceutical quality, safety and efficacy. An application for marketing authorization can be rejected if there exists, for example, negative benefit risk balance, insufficient documentation regarding GxP, insufficient qualification of impurity levels, substandard analysis methods or 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 sufficient or has not been submitted on time, the application may be rejected.

In case of refusal, a Public Assessment Report (PAR) will be published on the MPA website, describing briefly the reasons for refusal.

 
 
 
 

Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information