Marketing authorisation procedure with Latvia as reference member state
Application for decentralised and mutual recognition procedures with Latvia as a reference member state
Decentralised procedure
To authorise medicinal products via the decentralised procedure with Latvia (further in the text - SAM) as the reference member state, the applicant shall request a time slot. For this purpose, as well as to increase efficiency and transparency in planning and use of available capacity a planning tool is established by the SAM.
- Requests for DCP slot allocation: please click on this link, choose DCP applications and a time slot of your interest; fill in a request form for a time slot. Within two weeks after a time slot request’s submission, you will be informed by email whether or not the time slot has been allocated to your procedure.
It is necessary to apply for a DCP time slot in case of applications for marketing authorisation through line extensions. If the parallel/duplicate applications are submitted simultaneously, then it’s considered as one slot – a separate request for a time slot is not necessary.
- DCP slot postponement: the applicant shall apply for a DCP slot postponement as soon as practicable. The request shall be sent by email to the following email address - rms-lv@zva.gov.lv . The applicant will be informed about the postponement within 2 weeks of sending the request.
- DCP slot cancellation: the applicant should inform the SAM about the cancellation of the DCP slot as soon as practicable. The information on cancellation shall be sent by email to the following email address - rms-lv@zva.gov.lv .
- Change of the medicinal product within an already approved DCP slot: Change of the medicinal product (such as changes of the active substance, legal basis, pharmaceutical form) within an already approved time slot are generally discouraged. However, SAM may permit such changes in exceptional circumstances. The applicant shall notify SAM of any proposed changes as early as reasonably possible by sending an email to rms-lv@zva.gov.lv. If SAM does not approve the requested change, the applicant shall apply for a new DCP slot allocation. The allocation procedure is the same as described above. Concurrently, it is necessary to inform about the cancellation of the originally allocated DCP slot.
Mutual recognition/Repeat use procedure
In order to authorise medicinal products within the mutual recognition/repeat use procedure with Latvia as a reference member state, the applicant shall fill in a “Request form” available on the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) website and send a request including the preferred date for submission of MA documentation by email to the following email address - rms-lv@zva.gov.lv.
Within two weeks after a time slot request’s submission, you will be informed by email whether or not the time slot has been allocated to your procedure.
Taking over the functions of the reference member state
In exceptional circumstances, a marketing authorisation holder may request a change of the reference member state for a medicinal product authorised within the mutual recognition or decentralised procedure.
In this case the marketing authorisation holder shall fill in a “Request form” available on CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) website and send a request by email to the following email address - rms-lv@zva.gov.lv.
Within two weeks after a request’s submission, you will be informed by email whether or not the SAM agrees to take over the functions of the reference member state. If the SAM agrees, a new procedure number will be assigned to the procedure, the “original” reference member state and concerned member states will be informed of this fact.
The procedure for taking over the functions of RMS in Latvia SAM is free of charge.
See additional information regarding the procedure for taking over the functions of a reference member state on the CMDh website - https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/01_General_Info/CMDh_039_2002_Rev.9_CMDh_procedural_advice_on_changing_the_RMS_clean.pdf
In case of any questions regarding a time slot allocation, please contact us sending email to rms-lv@zva.gov.lv
