In order to facilitate export of medicinal products and to ensure fulfilment of import requirements of other countries, on the basis of an application from a medicinal product exporter (manufacturer or wholesaler) the State Agency of Medicines (hereinafter – SAM) may issue an export certificate – Certificate of Pharmaceutical Product and abbreviated product certificate or Free Sales Certificate.
Medicinal products, including investigational medicinal products, may be exported by a person to whom, in compliance with the regulatory acts regarding procedure for pharmaceutical activity licencing, SAM has issued a special permit (licence) for manufacturing or import of medicinal products or special permit (licence) for wholesale distribution of medicinal products for human use indicating the special activity condition – medicinal product export, or special permit (licence) for opening (operation) of a medicinal product wholesale facility, as well as by a person authorised to represent a licence holder.
On the basis of an application from a medicinal product or active substance (product) manufacturer registered in Latvia or a competent authority of a third country, SAM issues an abridged product certificate – Certificate of Pharmaceutical Product (CPP) or Free Sales Certificate (FSC). FSC is issued only for a single type of product (in English). If a medicinal product has several strengths, they are all considered as a single type of product. If a medicinal product has different pharmaceutical forms (e.g., tablets, solutions), a separate application must be submitted for each pharmaceutical form and separate FSC certificates are issued for each form.
The Free Sales Certificate is prepared according to the requirements of the third country indicated in the application as long as it does not contradict the World Health Organization (WHO) guidelines on the Implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce. A copy of summary of product characteristics, package leaflet and labelling in Latvian is attached to the FSC. If the applicant requires a summary of product characteristics, package leaflet and labelling in English, the applicant submits together with the application a notarial translation of the summary of product characteristics, package leaflet and labelling in English. The aforementioned requirement is not applicable to Free Sales Certificates issued for an active substance.
The procedure for issuance of a FSC is laid down by the Cabinet of Ministers of the Republic of Latvia Regulation No. 436 of 26 June 2007 “Procedures for Importation and Exportation of Medicinal Products”, Chapter IV “Exportation of Medicinal Products”, Articles 33, 351, 352, 353, 354, 371, 381 and 382.
SAM issues the FSC within 30 days after receipt of application. If a CPP has been issued for the product and a repeated compliance evaluation of good manufacturing practice or evaluation of data (pharmaceutical form and active substance specification) mentioned in Article 353 of the aforementioned Regulation is not required, the State Agency of Medicines issues a Free Sales Certificate within 10 days after receipt of application.
Submission of documents to request a Free Sales Certificate
1. In order to receive a Free Sales Certificate, medicinal product manufacturer registered in Latvia submits to SAM an application for issuance of a Free Sales Certificate. The application must be signed with a secure electronic signature (a) or in paper format (b):
a) Via e-mail to firstname.lastname@example.org, please sign the letter using a secure electronic signature (created with a secure tool for creating an electronic signature and verifiable with a qualified certificate).
b) Application in paper format may be submitted to SAM in person (Room 11) or sent via postal mail to the following address: Jersikas Street 15, Riga, LV-1003.
2. The application must contain all of the information required pursuant to Article 371 of the Cabinet of Ministers of the Republic of Latvia Regulation No. 436 of 26 June 2007 “Procedures for Importation and Exportation of Medicinal Products”.
3. Parallel to the submission of request for issuance of a Free Sales Certificate to SAM, the medicinal product manufacturer sends a completed FSC form in Word format via e-mail to email@example.com including the information required in Article 371 of the Cabinet of Ministers of the Republic of Latvia Regulation No. 436 of 26 June 2007 “Procedures for Importation and Exportation of Medicinal Products”.
The fee for this service has been determined in accordance with the Paid Service Pricelist of the State Agency of Medicines (Art. 61) – 55.00 EUR.
After the service has been provided, we will send an invoice to the provided e-mail address. When making payment, the invoice number and date must be indicated in the purpose of payment.
State Agency of Medicines of Latvia
Jersikas iela 15, Riga, LV-1003, Latvia
VAT reg. No. LV90001836181
The Treasury of the Republic of Latvia
BIC TRELLV 22XXX