Medical license in Latvia

The procedure for issuing a license for the sale of medicines in Latvia (hereinafter referred to as the License) is established by the Law “On Licensing Procedures for Pharmaceutical Activities” (hereinafter referred to as the Law on Licensing). The authority in the field of issuing such a license, in accordance with the legislation of Latvia, is exercised by the Agency for Conformity Assessment and the issuance or re-registration of licenses for the production or import of medicines (hereinafter referred to as the Agency). It should be noted that activities that involve the circulation of narcotic drugs or psychotropic substances are additionally regulated by special regulatory legal acts.

To obtain a License, the following documents must be submitted to the Agency:

1. Application of the established form.
2. List and description of medicines to be imported/exported.
3. Detailed description of the manufacturer of the indicated medicines.
4. Description of operations for the production/import of medicines.
5. Indicate the website of the manufacturer of medicines, as well as the website of the company that controls the quality of the medicines produced.
6. Description of the premises, technical means and devices that will be used in this type of activity.
7. Personnel data.

In addition, in the case of trafficking in narcotic drugs or psychotropic substances, the Agency will require additional information and documents in accordance with the legislation governing the trade, storage and transportation of such medicines.

It is also worth noting that the concept of “description” means not only general information, but documentary evidence of the latter. For example, when describing premises, technical means and devices, it will also be necessary to provide documents for storage facilities (lease or sale agreement, floor plan, technical specifications), vehicles (lease or sale agreement, description of equipment that vehicles are equipped), documentary evidence of the availability and characteristics of refrigerating chambers (if necessary, their use) and other documents.

Corporate Legislation of Latvia