1. National Marketing Authorisation Procedure, Decentralised Procedure, Mutual Recognition Procedure

1.1  National Marketing Authorisation Procedure

1.1.1 What is the time frame for getting a national approved Marketing Authorisation? 

The time frame for the procedure is approximately one year.
Processing time totals 210 days, with two breaks for collecting additional information. The first round is 110 days, the second is 55 days and the final round is 45 days.

1.1.2 What is a clock-stop period and how long is it? 

A clock-stop period is the time during which the Swedish Medical Products Agency awaits further data in response to questions raised. Days counted during the clock-stop period are not counted into the total processing time of 210 days for the approval process for a national approved marketing authorisation.

The first clock-stop period is 90 days. After the second processing round the MPA can request additional information and the clock stop period is then 40 days.

1.1.3 Do we have to pre-book a slot time before submitting an application?

Pre-booking is not needed.

1.1.4 How do we get the assessment report during the procedure and the final Authorisation?

A positive decision, an approval, can be sent electronically. These decisions are not signed.

A negative decision, a rejection, will still be sent on paper and signed.

1.1.5 Production has not started yet, so we have no samples that we can send with the application. What do we do?

The MPA accepts samples from stability studies, which should be completed before the application is submitted.

1.1.6 The label is not approved yet, so we have no samples of labelling in English or Swedish. Can we send in samples without labelling or labels in a different language? 

Yes, samples which are sent at this stage of the application is primarily to investigate the usability and need not to be marked. It is appreciated however, if there is some mark that facilitates the identification of the sample, such as the Asp number or procedure number.

1.1.7  We want to withdraw our application, is it possible to avoid the application fee?

No, usually not. If special reasons apply, the applicant might request for a reduction of the application fee.

1.1.8  Do you require original signatures on application forms relating to the approval of medicinal products?

No, it is not necessary.

1.2  The Decentralised Procedure

1.2.1 How do we get the Swedish Medical Products Agency, MPA, to act as reference member state (RMS) in a decentralised procedure (DCP)?

A request for the MPA to act as RMS in a DCP can be submitted at any time and requests will be handled continuously. You are asked to request the MPA to act as RMS at least 3 months before planned submission. See the following link for the request form and details on the procedure.

 DCP with Sweden as RMS

1.2.2 The MPA has previously acted as RMS in a DCP for our product. How do we apply for a duplicate through DCP?

Also for duplicates you are asked to request the MPA to act as RMS at least 3 months before planned submission, see the following link for the request form and details on the request procedure. 

 DCP with Sweden as RMS

For further information on the MPA’s view on duplicates see the documents ”Practical guidance for submission of applications for human medicinal products” for human medicinal products and ”Practical guidance for submission of applications for veterinary medicinal products” for veterinary medicinal products which can be found at

 New applications  

Here you can also find the form “Statement for Duplicate applications” which we request you submit together with your planned application.

1.2.3 The MPA has previously acted as RMS in a DCP for our product. How do we apply for an extension through DCP?

Also for extensions you are asked to request the MPA to act as RMS at least 3 months before planned submission, see the following link for the request form and details on the request procedure.

 DCP with Sweden as RMS 

1.2.4 If the MPA will not be able to accommodate our application according to our request, do you have a waiting list?

No, we have no waiting list. We do, however, have a mailing list and companies can sign up to receive information through email when the MPA has available slots due to e.g. cancellations. Since we accept requests 3 months before planned submission this would only apply to slots being available with short notice. In order to sign up for this mailing list please send an email to DCP-RMS-booking@lakemedelsverket.se and include “DCP RMS mailing list” in the heading of the email.

1.2.5 Production has not started yet, so we have no samples that we can send with the application. What do we do?

The MPA accepts samples from stability studies, which should be completed before the application is submitted.

1.2.6 The label is not approved yet, so we have no samples of labelling in English or Swedish. Can we send in samples without labelling or labels in a different language?

Yes, samples are sent at this stage of the application is primarily to investigate the usability and need not be marked. It is appreciated however, if there is some mark that facilitates the identification of the sample, such as the procedure number.

1.2.7  We want to withdraw our application, is it possible to avoid the application fee?

No, usually not. If special reasons apply, the applicant might request for a reduction of the application fee.

1.3  The Mutual Recognition Procedure 

1.3.1 How do we get the MPA to act as reference member state (RMS) in a mutual recognition procedure (MRP)?

You are asked to submit a request that the MPA should act as RMS at least 3 months before planned submission.

See the following link for the request form and details on the procedure.

 MRP with Sweden as RMS

1.3.2 Do we have to prebook a slot time before submitting the application?

Prebooking is not needed.

1.3.3 Is it possible to submit MRP request for a product while the national authorisation procedure is ongoing?

 

No, the national authorisation should be granted for the product concerned before a MRP request is submitted to the MPA.

1.3.4 Is it possible to start the MRP procedure while variations are ongoing for the concerned product?

 

No, all the variations and renewal should be finalised in order to start the procedure.

 
 

Contact us

National Market Authorisation Procedure
Magdalena Eriksson 
magdalena.eriksson@lakemedelsverket.se

Decentralised procedure
Catarina Wallén
catarina.wallen@lakemedelsverket.se

Procedure for Mutaul Recognition
Helena Malm
helena.malm@lakemedelsverket.se

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information