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Authorisation procedure with Latvia as reference member state

Application for decentralised and mutual recognition procedures with Latvia as a reference member state


In order to authorise medicinal products via the decentralised, first or repeat mutual recognition procedure with Latvia (SAM) as a reference member state, the applicant must first inform the State Agency of Medicines (SAM). Applications with the request for Latvia (SAM) to act as the reference member state should be sent to the following SAM e-mail address: rms-lv@zva.gov.lv:

1) In the case of decentralised procedures, a completed “Request form” should be attached to the electronic report – the form is available on CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) website – and the preferred date for submission of documents should also be indicated.

2) In case of the first or repeat mutual recognition procedure, a completed “Request form” should be attached to the electronic report – the form is available on CMDh website – and the preferred date for submission of documents should also be indicated.

 

Applicants shall be informed regarding the reservation for submission of documents within the indicated time period. SAM shall provide information regarding all changes in submission dates of approved documents as soon as possible.

 

Taking over the functions of the reference member state

There are cases where the marketing authorisation holder may require a change in the reference member state.

Requests for Latvia (SAM) to take over the role of the reference member state should be sent to the following e-mail address: rms-lv@zva.gov.lv. A completed “Request form” should be attached to the electronic report – the form is available on CMDh website.

The submitter of the request shall be informed whether Latvia (SAM) is able to take on the role of the reference member state. If Latvia (SAM) agrees to take over the functions of RMS, a new procedural number shall be assigned to the procedure and the submitter of request, the “original” RMS and concerned member states shall be informed of this fact.

The procedure for taking over the functions of RMS in Latvia (SAM) is free of charge.

 

Additional information

See additional information regarding the procedure for taking over the functions of a reference member state on CMDh website:

1) Procedure

2) CMDh extension of the pilot for splitting of procedures.