In order to facilitate export of medicinal products and to ensure fulfilment of import requirements of other countries, upon request 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.
SAM issues a Certificate of Pharmaceutical Product (CPP) based on an application by the national competent authority of a medicinal product manufacturing, exporting or importing country. A product is a medicinal product for human use in its final pharmaceutical form and active substance for use in such pharmaceutical forms subjected to control in both exporting and importing countries pursuant to pharmaceutical regulatory acts. CPP is compliant with the form recommended by the World Health Organisation (WHO) and determines product status, as well as the status of the certificate applicant in the exporting country. The certificate is intended only for a single type of product.
The procedure for issuance of CPP 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” (hereinafter – Regulation No. 436), Chapter IV “Exportation of Medicinal Products”, Articles 33, 35, 36, 38 and 383.
Article 33 of Regulation 436 states that medicinal products may be exported only by a medicinal product manufacturer or wholesaler registered in the Republic of Latvia or by a person who authorised to represent of a licence holder. According to Article 351 of the Regulation, a marketing authorisation holder has the right to request from SAM a CPP for a medicinal product manufactured in another European Union (hereinafter – EU) member state, if this medicinal product is being exported from Latvia.
According to the abovementioned, SAM has the right to issue a CPP for medicinal products for human use subject to control both in the exporting country (Republic of Latvia) and importing country (third country) according to pharmaceutical regulatory acts, and with the CPP SAM confirms compliance of the medicinal product under its control that is being exported from Latvia as an exporting country to a third country.
If the product is manufactured in another EU member state and is exported via Latvia to a “third country” with accompanying documentation where a different EU member state is indicated as the exporting country, the CPP for such a medicinal product is not issued by the State Agency of Medicines of Latvia, but by the competent authority of the relevant member state.
SAM issues the Certificate of Pharmaceutical Product within 30 days after receipt of application.
Submission of documents to request a Certificate of Pharmaceutical Product
1. In order to receive a CPP, medicinal product manufacturer submits to SAM an application for issuance of a CPP. The application must be signed with a secure electronic signature (a) or in paper format (b):
a) Via e-mail to email@example.com; 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 submit all of the information required pursuant to Article 36 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 CPP to SAM, the medicinal product manufacturer sends a completed CPP form in Word format via e-mail to firstname.lastname@example.org.
The fee for this service has been determined in accordance with the Paid Service Pricelist of the State Agency of Medicines (Art. 60) – 100.00 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