The State Agency of Medicines increases the number of various e-permits

The State Agency of Medicines increases the number of various e-permits

The State Agency of Medicines informs that it has initiated the issuance of electronic documents (permits, authorisations etc.) as laid down in the normative acts of the Republic of Latvia*.

Clients of the State Agency of Medicines may receive the following documents in electronic format:

1. Authorisations for a person performing intermediary operations with medicinal products;
2. Permits for import of samples of medicinal products in the Republic of Latvia;
3. Permits for distribution of parallel imported medicinal products in the Republic of Latvia;
4. Permits for distribution of remaining stock of medicinal products;
5. Permits for distribution of medicinal products authorised in a European Economic Area member state, but not authorised in the Republic of Latvia;
6. Permits for distribution of individually approved medicinal products not authorised in the Republic of Latvia.

In order to receive these electronic documents please note the following conditions - when submitting the application, please indicate a safe electronic mail address that ensures the receipt of electronically signed documents, thus, assuming responsibility for the safe work environment and the appropriate software of your computer. If the client wishes to receive the aforementioned documents in paper format, it should be indicated upon the initial submission of documents.

Furthermore, please note that in accordance with normative acts starting from July 1st, 2014, the aforementioned documents will be issued in paper format only for an additional fee.

 
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18th April 2006 CM Regulation No 304 “Regulations Regarding the Procedures for the Manufacture and Control of Medicinal Products, the Requirements for the Qualification and Professional Experience of a Qualified Person and the Procedures for the Issuance of the Certificate of Good Manufacturing Practice to a Medicinal Products Manufacturing Undertaking”; 26th June 2007 CM Regulation No 416 “Procedures Regarding Distribution and Quality Control of Medicinal Products”; 26th June 2007 CM Regulation No 436 “Procedures Regarding Importation and Exportation of Medicinal Products”.