Medicinal products for animals

Centralised procedure

The scientific investigation is the same as for medicinal products for human use.

The application is sent to the European Medicinal Agency (EMA) where the Committee for Medicinal Products for Veterinary Use (CVMP) appoints two National competent authorities (NCA) who, based on competence and national priorities have nominated interest in assessing the application and thus become Rapporteur or Co-Rapporteur.

This procedure is mandatory for medicinal products for animals that:

• Is developed by means of certain biotechnological processes.
• Is performance enhancing for growth.
• Contains an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application.
• Biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells.
• Novel therapy veterinary medicinal products.

For veterinary medicinal products other than those referred to above, a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union. For details, refer to Regulation (EU) 2019/6 of the European parliament and of the council, article 42.

Decentralised procedure

In the decentralised procedure (DCP), the medicinal product is not previously approved for the applicant in the EU nor Iceland, Liechtenstein and Norway. Applicants choose to which countries they want to submit their application and which one of these should take responsibility as the Reference Member State. Request for Sweden as reference member state is possible.

Reference Member State

The main assessment of an application in DCP is carried out by the national authority which has accepted the applicant’s Reference Member State (RMS) request. Other countries included in the procedure will be Concerned Member States (CMS). An application in DCP is only submitted after a time slot have been agreed by the prospective RMS and applicant.

The total assessment time shall not exceed 210 calendar days. Applicants are given the opportunity to supplement their application based on the questions asked by RMS and CMS. The applicant prepares the response during a so-called clock-stop, which is not included in the assessment time. If the applicant answers all questions satisfactorily and the benefit-risk balance is judged to be positive, all countries involved agree upon approval before end of procedure.

Sweden as RMS in a DCP

The applicant is asked to submit their RMS request no later than three months before the planned submission date.

• The form is sent via email to registrator@lakemedelsverket.se.
• Write "DCP RMS request veterinary medicinal product" in the header of the email.
• All requests will be answered as soon as possible but no later than three weeks after the request was received.
• Applicants who have been notified that the Swedish MPA will act as RMS for their application must be able to keep the planned submission date and notify the agency immediately if there are delays.

Mutual recognition procedure and Subsequent Recognition procedure

The mutual recognition procedure can be used when a medicinal product is already approved in an EU country, called a Reference Member State (RMS), and wishes to get the product approved in additional countries within the EU or Iceland, Liechtenstein and Norway.

For a medicinal product which is already approved through the National Procedure (NP), the Mutual Recognition Procedure (MRP) can be used to expand the registration to one or more other countries (Concerned Member States, CMS). A minimum of six months is required between the decision granting the national MA and submission of an application for a MRP.

For a product which has been approved through the decentralised procedure (DCP) or which has previously undergone MRP, the corresponding procedure is called SRP (Subsequent Recognition Procedure, former repeat use procedure).

Update the dossier if needed

It is important that applicants, before submitting the request, consider whether any variations need to be submitted to update the dossier for it to comply with current legislation and guidelines.

Please note that any variations must be approved before the request is submitted. If there are ongoing variations, the request will not be further handled until these have been approved. No variations may be ongoing in parallel with the update of the assessment report.

Sweden as RMS in MRP/SRP

The request must be submitted at least three months before the preferred starting date of the procedure. Applicants do not need to book a time slot in advance. The request is considered valid when there are no ongoing variations and all relevant attachments have been submitted.
This is a formal request to the Swedish MPA to begin updating the assessment report. The invoice for the application fee will be issued when the Swedish MPA has received the request.

• Form and relevant attachments as detailed in the form are sent via email to RIC@lakemedelsverket.se
• Write "MRP RMS request veterinary medicinal product" in the header of the email.

National procedure

Authorisation through the national procedure can be obtained for medicinal products intended for marketing only in Sweden. A national application for a marketing authorisation can be submitted to the Swedish Medical Products Agency without any prior request for a time slot. The validation period is 15 calender days and starts when the application has been submitted. Thereafter the procedure is the same for veterinary medicinal products as for human medicinal products.

Duplicate application

The applicant may get marketing authorisation for one product by sending in one or serveral duplicate applications.

Electronic application

The Swedish Medical Products Agency follows the EU eSubmission Roadmap. This means that all applications for marketing authorisations should be submitted electronically. It is mandatory to use the VNeeS format for all products for veterinary use both within EU procedures and the national procedure.

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