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New wholesaler

 

A medicinal product wholesale licence is required to purchase, store and distribute medicines and other medicinal products, as well as goods utilised in healthcare or body care, medical products for persons with disability, pharmacy equipment, medical instruments and equipment.

In order to receive a licence for wholesale distribution of human medicinal products, an “Application for compliance evaluation and issuance or renewal of special permit (licence) for establishment (operation) of medicinal product wholesaler"  must be submitted to the State Agency of Medicines (SAM). 

Submission options: in person – at SAM Client Service Centre (Room 11), via mail or by sending an e‑signed application to the following e‑mail address: info@zva.gov.lv.

 

Payment procedure

Prior to issuance of the aforementioned licence, the client must pay the state tax in accordance with the requirements pursuant to Paragraph 75 of the Cabinet of Ministers Regulation No. 800 of 19 October 2011 “Procedure for Licensing of Pharmaceutical Activity”. The payment of the state tax shall be transferred to the state treasury account: LV48TREL1060000921500, (please indicate the name of the pharmaceutical activity company, licence type (medicinal product wholesale distributor) and recipient).

Payment for issuance of medicinal product wholesale licence shall be made in accordance with the SAM paid service pricelist. The licence for operation of medicinal product wholesale distributor shall be sent within 5 working days to the legal address of the applicant or to the address indicated in the application if the applicant has provided another address for correspondence.

 

Additional information

Administrative Procedure Law

Pharmaceutical Law

Cabinet of Ministers Regulation No. 441 of 17 June 2008 “Procedures for the Purchase, Receipt, Storage, Distribution, Dispensation, Accounting and Destruction of Narcotic and Psychotropic Substances and Medicinal Products in Manufacturing of Medicinal Products and Veterinary Medicinal Products, at Drug and Veterinary Drug Wholesalers and Pharmacies

Cabinet of Ministers Regulation No. 416 of 26 June 2007 “Regarding Procedure for Distribution and Quality Control of Medicinal Products”.