Review of submitted names
- Published: May 13, 2024
- Last updated: May 13, 2024
- Topics: Package leaflet, Veterinary medicinal products, Labelling
The Swedish Medical Products Agency reviews the submitted names for all new applications in national, decentralised, mutual recognition and subsequent procedures.
A submitted name will only be approved in conjunction with the medicinal product being approved or registered in Sweden.
Name changes for already approved or registered medicinal products
Review of a new name prior to a variation request
A name change request for an already approved or registered veterinary medicinal product shall be made through a variation, by registering the information in the Union's database on veterinary medicinal products (UPD). However, the Swedish name must before that have been reviewed and accepted by the Swedish Medical Products Agency (Swedish MPA) in a ”national pre-process”, by the applicant sending an email to the Swedish MPA requesting a name change.
If the proposed name is accepted, the Swedish MPA sends a confirmation letter (”Confirmation of name suggestion”) to the applicant. This document must be uploaded in the UPD as a supporting document when the variation is submitted.
Name change
The change must be registered in the UPD within 30 days after the company has received the Swedish MPA's confirmation letter from the national pre-process. However, if other Member States are affected by the change, registration shall take place no later than 30 days after receipt of the last confirmation (classification code A.2). The Swedish MPA and the applicant must agree on a time for the implementation of the new name. The implementation date may be set a maximum of one year in advance from the date of the confirmation letter.
In connection with the implementation of the new name, the Swedish MPA will update its database, as well as update and publish the product information under the new name. Packages with the old and the new name may only be available in parallel for one month from the agreed implementation date.
The MAH change must be completed before a name change to a generic name plus new MAH can be made.
Special rules for medicinal products subject to parallel trade
A name change request for an already licenced veterinary medicinal product subject to parallel trade shall be made through a variation application.
The name is reviewed and approved by the Swedish MPA. The Swedish MPA and the applicant agree on a time for the implementation of the new name.
In connection with the implementation of the new name, the Swedish MPA will update its database, the UPD as well as update and publish the product information under the new name. Packages with the old and the new name may only be available in parallel for one month from the agreed implementation date.
The change of wholesale distributor in the destination Member State must be completed before a name change to a generic name plus a new wholesale distributor in the destination Member State can be made.
Review of submitted names
- Published: May 13, 2024
- Last updated: May 13, 2024
- Topics: Package leaflet, Veterinary medicinal products, Labelling
The Swedish Medical Products Agency reviews the submitted names for all new applications in national, decentralised, mutual recognition and subsequent procedures.
A submitted name will only be approved in conjunction with the medicinal product being approved or registered in Sweden.
Name changes for already approved or registered medicinal products
Review of a new name prior to a variation request
A name change request for an already approved or registered veterinary medicinal product shall be made through a variation, by registering the information in the Union's database on veterinary medicinal products (UPD). However, the Swedish name must before that have been reviewed and accepted by the Swedish Medical Products Agency (Swedish MPA) in a ”national pre-process”, by the applicant sending an email to the Swedish MPA requesting a name change.
If the proposed name is accepted, the Swedish MPA sends a confirmation letter (”Confirmation of name suggestion”) to the applicant. This document must be uploaded in the UPD as a supporting document when the variation is submitted.
Name change
The change must be registered in the UPD within 30 days after the company has received the Swedish MPA's confirmation letter from the national pre-process. However, if other Member States are affected by the change, registration shall take place no later than 30 days after receipt of the last confirmation (classification code A.2). The Swedish MPA and the applicant must agree on a time for the implementation of the new name. The implementation date may be set a maximum of one year in advance from the date of the confirmation letter.
In connection with the implementation of the new name, the Swedish MPA will update its database, as well as update and publish the product information under the new name. Packages with the old and the new name may only be available in parallel for one month from the agreed implementation date.
The MAH change must be completed before a name change to a generic name plus new MAH can be made.
Special rules for medicinal products subject to parallel trade
A name change request for an already licenced veterinary medicinal product subject to parallel trade shall be made through a variation application.
The name is reviewed and approved by the Swedish MPA. The Swedish MPA and the applicant agree on a time for the implementation of the new name.
In connection with the implementation of the new name, the Swedish MPA will update its database, the UPD as well as update and publish the product information under the new name. Packages with the old and the new name may only be available in parallel for one month from the agreed implementation date.
The change of wholesale distributor in the destination Member State must be completed before a name change to a generic name plus a new wholesale distributor in the destination Member State can be made.