Prior to initiation of medicinal product distribution or temporary or permanent discontinuation of medicinal product supply, the marketing authorisation holder must inform the State Agency of Medicines (SAM).
- The notification regarding the date of initiation of medicinal product distribution must include the following information:
- For medicinal products authorised and parallel imported in Latvia: product number in the Medicinal Product Register.
- For centrally authorised and parallel distributed medicinal products: the European Union number assigned by the European Medicines Agency for every packaging size of the authorised pharmaceutical form.
- The product number must be indicated in the notification regarding discontinuation of supply. This notification must be submitted to SAM at least two months prior (except extraordinary circumstances) to discontinuation of medicinal product release on the market.
A free-form notifications in both cases should be sent to the following e-mail address: info@zva.gov.lv.
Additional information
Cabinet of Ministers Regulation No. 416 of 26 June 2007 “Procedure for Distribution and Quality Control of Medicinal Products” (Subparagraph 153.3).
