Authorisation for Import and Export of Narcotic and Psychotropic Substances or Medicinal Products
Import – the physical movement of narcotic and psychotropic substances and medicinal products from the territory of another state to the territory of Latvia, by bringing them in to the territory of Latvia.
Export – the physical movement of narcotic and psychotropic substances and medicinal products from the territory of Latvia to the territory of another state, by taking them out of the territory of Latvia.
Import or export of substances or medicinal products included in registers II and III of narcotic, psychotropic substances and precursors controlled in Latvia may be conducted only following receipt of authorisation issued by the State Agency of Medicines (SAM) in accordance with the requirements of the United Nations (UN) Economic and Social Council’s Commission on Narcotic Drugs.
Authorisations for import, export of narcotic and psychotropic substances or medicinal products are issued in the format of a paper document:
- In case of import, three copies of the authorisation are issued to the client. If the shipment comes from a country that is not a European Union (EU) member state, four copies of authorisation are issued.
- In case of export, two copies of the authorisation are issued to the client. If the shipment is made to a country that is not a European Union (EU) member state, three copies of authorisation are issued.
The client receives the issued import and export authorisations at the Agency, signing for receipt in the corresponding register.
In order to receive the aforementioned authorisation for import or export, the marketing authorisation holder, that has received a special permit (licence) for pharmaceutical activity permitting activities with psychotropic or narcotic substances or medicinal products, must submit the following documents:
- Application for receipt of authorisation;
- In addition to the application for export authorisation, the MAH must submit import authorisation issued by the competent authority of the import country (if stipulated by the laws of the relevant country).
The application may be submitted in person, via mail or signed with a secure electronic signature and sent to the following e‑mail address: firstname.lastname@example.org (in case of import or export – only if submission of import authorisation issued by the competent authority of the import country is not required).
Information that must be included in the application is laid down by Paragraph 20 of the Law of “On Procedures for the Legal Trade of Narcotic and Psychotropic Substances and Medicinal Products”
After receipt of service
The volume of substances or medicinal products actually imported or exported must be indicated on one of the import or export authorisation copies, respectively, and submitted to SAM.
- Payment for expertise on application documentation for import or export of psychotropic and narcotic substances and medicinal products, as well as precursors is determined in accordance with Article 27 of the SAM paid service pricelist.
- Payment for issuance of authorisation for import or export of psychotropic and narcotic substances and medicinal products, as well as precursors is determined in accordance with Article 36 of the SAM paid service pricelist.
After issuance of authorisation an invoice will be issued. Upon making payment, the invoice number and date, as well as name, surname or title of payer must be indicated in the “purpose of payment”.
Cabinet of Ministers Regulation No. 847 of 8 November 2005 “Regulation Regarding Narcotic Substances, Psychotropic Substances and Precursors Controlled in Latvia”