Medicinal products, including investigational medicinal products, may be exported by a person to whom, according to 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 manufacturer, competent authority of an exporting or importing country, SAM issues a statement regarding product certification status. This statement shall be intended for a representative of the importer of medicinal products, who participates in international offers (tenders) in accordance with the requirements of the invitation. This statement shall denote that the specific medicinal products have been registered in the Republic of Latvia (exporting state) and they are permitted to be distributed. Upon request of the applicant and the medicinal product authorisation holder, if they are different persons, the State Agency of Medicines shall issue the certificate of a pharmaceutical product referred to in Sub-paragraph 35.1 of this Regulation for each product referred to in the statement.
The procedure for issuance of statement regarding product certification status 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, 35, 37, 38 and 383.
SAM issues the statement of product registration status within 30 days after receipt of application.
Submission of documents to request a product certificate
1. In order to receive a statement regarding product registration status, a person submits to SAM an application for issuance of statement regarding product registration status. 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 contain all of the information required pursuant to Article 37 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. The data required for statement of product registration status must be sent in electronic format to the e-mail address: 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. 12) – 41.00 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
Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce
Adopted guidance: WHO certification scheme on the quality of pharmaceutical products moving in international commerce: Questions and Answers (Q & A)
Statement of licensing status of pharmaceutical product(s)
WHO certification scheme on the quality of pharmaceutical products moving in international commerce: with an updated list of participating countries, Rev. 5