16 January 2012

The State Agency of Medicines (SAM) of Latvia is planning to introduce an online system for exchange Regulatory Documentation (Product Information).

The State Agency of Medicines (SAM) is planning to introduce an online system for exchange of documentation between The State Agency of Medicines (SAM) and the party submitting their Regulatory Documents.

The SAM Human Medicines Evaluation Department is preparing to organize an electronic evaluation and correction of product information (summary of product characteristics /package leaflet/ labels) submitted for marketing authorization, renewal and variations in the national procedure similarly as it is already being done in the national phase of mutual recognition/ decentralized procedures.

SAM is requesting parties to use the currently available e-mail np_pi@zva.gov.lv to submit electronic versions of product information.

While sending the electronic mail to SAM need to indicate the following information

The name, Authorization number and Type of application (authorization, renewal, variation) for the medicine and the date of document submission to SAM.

SAM requested do not use or limit the use of CD’s to submit the electronic version of the product information.

Kindly note: The above mentioned e-mail address is not intended for submitting questions or other documentation.

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