Variations

Human medicines

Application

Applications are sent electronically in all procedures. The recommendation is that the application is sent in the EU approved electronically format eCTD.

You can find the application forms on the EMA website.

Submission of application

The documentation to be supplied for different types of variations is listed in the classification guideline for variations.

In addition to this the following should be submitted:

• cover letter with the scope and reference to the procedure number
• application form
• power of attorney if the contact person is someone else than MAH or the local representative.

Guidelines on the details of the various categories of variations

Variation procedure number

Allocation of variation procedure number for human medicinal products are handled by the applicant according to guidelines from CMDh. However, there are two exceptions:

Planned super-grouping

For grouped applications including more than on  MA (type IA only) the variation procedure number needs to be obtained from the Reference Authority.

For human medicinal products the request should be submitted using the template for the letter of intent, available on the CMDh website.  

Worksharing

Request for worksharing should be submitted using the template for the letter of intent for the submission of a worksharing procedure, available on the CMDh website. Submit the request for human medicinal products to the preferred Reference Authority. For more information see Chapter 7 of the CMDh Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure.

Requests for variation procedure numbers when Sweden is RMS should be sent by email to RIC@lakemedelsverket.se.

Procedural guidance

Fees

An invoice on the application fee will be sent upon receipt of the application, so no payment should be made in advance.

Changes to the product information

If the variation affects the product information updated product information should be submitted.

For type IA variations that affect the product information, only changes resulting from the variation applied for will be considered. If the MAH wish to make minor editorial corrections in the texts in connection with a variation type IB or II under Chapter C in the classification guideline and that affects the product information, the corrections should be clearly outlined in the application form under scope and present/proposed, and marked as tracked changes in the product information.

When a variation affecting the labelling or package leaflet has been approved, no packages with previously approved labelling or package leaflet may be released onto the market after six months. After assessment in each individual case, the Swedish MPA can decide that the implementation period should be longer or shorter than six months. For non‍-‍urgent, or purely administrative changes, to the package leaflet and labelling, the Swedish MPA can decide on an implementation period of up to twelve months. This mainly applies to changes that do not affect safety, handling or administration of the medicinal product.

In section 23 of the Swedish Medical Products Agency’s Provisions (HSLF‍-‍FS 2021:96) there is more information on how different types of changes to the labelling or package leaflet may be assessed.

Product information 

Timetables

Prior to start of variation procedures, there is a mandatory auto validation period (7 calendar days for type IB, and 14 calendar days for type II).

The evaluation time is stated in days, both the days for the primary round and the total number of days excluding clock stop.

In the mutual recognition procedure, a clock stop includes both the applicant's reply limit and the authorities’ time to assess the response.

In the national procedure, the procedure is re-started upon receipt of the response.

Mutual recognition procedure

National procedure

Communication at the closure of the procedure

For applications in the national procedure, a confirmation letter/approval letter is sent to the applicant when the case is closed.

For applications in the mutual recognition procedure, the RMS/‌Reference Authority always notifies the end of the procedure.

In cases where the product information is affected, updated Swedish texts and confirmation letter/approval letter will be sent separately from the Swedish MPA.

Regulation

The variation regulation (EC) No 1234/2008

Veterinary medicines

Variation not requiring assessment (VNRA)

The marketing authorisation holder for a veterinary medicinal product should register a variation not requiring assessment in the union product database (UPD) within 30 days following implementation.

Timetables

The processing time for a VNRA is 30 days.

Change in product name

Change in the product name for a veterinary medicinal product should be recorded in the UPD as a VNRA. Before the change can be recorded in the UPD a confirmation that the new name is acceptable for the Swedish MPA is needed. A notification should be submitted to the Swedish MPA in order to agree on a new product name.

How to submit the notification to the Swedish MPA, acceptability review process

The notification should be submitted via email to RIC@lakemedelsverket.se.

The following should be submitted:

• Cover letter containing a short description of the notification. The suggested name should be included. Maximum two name suggestions can be stated.
• Power of attorney if the contact person is someone else than MAH or the local representative.

Timetable

The evaluation time is 30 days.

Communication at the closure of the pre‍-‍procedure

The Swedish MPA will provide a confirmation via email when the procedure is closed. The confirmation of the new name is valid for one year. Please note that the variation must be recorded in the UPD within 30 days following the last MS‍-‍confirmation.

Name of medicinal products

The Swedish Medical Products Agency’s provision HSLF‍-‍FS 2021:97 for labelling and package leaflets and guideline for naming medicinal products can be found on the web page How to prepare the product information for submission.

Communication at the closure of the procedure

For national applications, the Swedish MPA will record the outcome of the procedure in the UPD.

For applications in mutual recognition procedure, the RMS will record the outcome of the procedure in the UPD. In cases where the product information is affected, updated Swedish texts and approval letter will be sent separately from the Swedish MPA.

Variation requiring assessment (VRA)

Submission of application

Applications should be sent electronically. The recommendation is that the application is sent in the EU approved electronically format VNeeS. For ASMF the EU approved electronically formats are eCTD, NeeS and VNeeS.

You can find the application forms on the EMA website.

Submission of application

The documentation to be supplied for different types of variations is listed in the classification guideline for variations requiring assessment.

In addition, the following should be submitted:

• cover letter with the scope and reference to the procedure number
• application form
• power of attorney if the contact person is someone else than MAH or the local representative
• CESP delivery file.

Variation procedure number

Allocation of variation procedure number for veterinary medicinal products should be handled according to guidelines from CMDv.

However, there are two exceptions:

Planned grouping

For grouped applications including more than one MA, the variation procedure number needs to be obtained from the RMS. The templet for letter of intent should be used. The template is available on the CMDv website.

Requests for variation procedure numbers when Sweden is RMS should be sent by email to RIC@lakemedelsverket.se.

Worksharing

Request for worksharing should be submitted using the template for the letter of intent for the submission of a worksharing procedure, available on the CMDv website. Submit the request for veterinary medicinal products to the preferred Reference Authority.

Requests for variation procedure numbers when Sweden is Reference Authority should be sent by email to RIC@lakemedelsverket.se.

Fees

An invoice on the application fee will be sent upon receipt of the application, so no payment should be made in advance.

Changes to the product information

If the variation affects the product information updated product information should be submitted.

When a variation affecting the labelling or package leaflet has been approved, no packages with previously approved labelling or package leaflet may be released onto the market after six months. After assessment in each individual case, the Swedish MPA can decide that the implementation period should be longer or shorter than six months. For non‍-‍urgent, or purely administrative changes, to the package leaflet and labelling, the Swedish MPA can decide on an implementation period of up to twelve months. This mainly applies to changes that do not affect safety, handling or administration of the medicinal product as well as QRD template changes according to classification VRA G.I.18.

In section 6 of the Swedish Medical Products Agency’s Provisions (HSLF‍-‍FS 2021:97) there is more information on how different types of changes to the labelling or package leaflet may be assessed.

Timetables

Prior to start of variation procedures, there is a mandatory auto validation period of 15 days. The evaluation time is stated in days. The total time is given excluding clock stop.

In the mutual recognition procedure, a clock stop includes both the applicant's reply limit and the authorities’ time to assess the response. In the national procedure, the procedure is re-started upon receipt of the response.

Mutual recognition procedure

National procedure

Communication at the closure of the procedure

Regulation