1. solis /
In order to fully assess the conformity of the product referred to in the application with the definition of medicinal products, the documents and data listed in paragraph 127 of Regulation No 376 'Procedures for the Registration of Medicinal Products' shall be submitted to the ZVA:
- the name, registration number and address of the manufacturer and distributor (distributor) firm;
- the name of the product, the ingredients and their quantity (s) in units of mass or volume per unit of packaging;
- regulatory technical documents approved by the manufacturer or a description of the product showing the characteristics, composition, specific components and their quantity;
- the recommended daily dose;
- the type and size of the packaging;
- the labelling text;
- a model for the instructions for use;
- other information materials on the product under consideration.
Types of submission:
Zva in the Customer Service Centre (office 11), by post (address: Jersik Street 15, Riga, LV-1003) or by email: firstname.lastname@example.org (documents must have been signed using an e-signature).
The execution of the service is commenced only when a full prepayment for the service has been performed in accordance with the State Agency of Medicines charge schedule.