Translated using machine translation service Hugo.lv
Assessment of the product documentation on its compliance with the definition of medicinal products
The selected organisation: Zāļu valsts aģentūra
Short description:
The manufacturer of the product or his representative shall request an assessment to determine whether the product produced by it complies with the definition of the medicinal product.
Beneficiaries:
Legal persons governed by public law, Private law legal persons
Duration:
Within 2 months
Process description
Documents and forms
Other information
1. solis / Service requests
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: info@zva.gov.lv (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.
Payments: View payments
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details: Klientu apkalpošana 11. kabinets.
Working time
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details:
Working time
2. solis / A service charge
Procedures for Settlement

This service should be prepayed in full in accordance with the State Agency of Medicines Charge Schedule (Annex, p. 9) - EUR 650,00.

To receive a prepayment invoice, please send the Payment Application for Prepayment to e-mail: rekini@zva.gov.lv.

After you have received a payment application, we will send a prepayment invoice to the email address you specified. When you pay, you must specify the number and date of the prepayment invoice for the payment purposes.

Properties
State Agency of Medicines
Jersika Street 15, Riga LV-1003
Sales tax exempt. No. LV90001836181
The TREASURY
LV24TREL9290579005000
BIC TRELLV 22XXX
Payments: View payments
3. solis / Receipt of services
Receipt of an opinion

An opinion on whether the product concerned meets or does not comply with the definition of the medicinal product shall be delivered by the ZVA within two months.
An opinion regarding the conformity of the product with the definition of medicinal products specified in the Pharmaceutical Law may be received in the form of an electronic document. If the applicant wishes to obtain an opinion in paper form, the ZVA should be informed thereof, which will, after preparing the opinion, send it to the applicant's registered office or, if the applicant has indicated a different address for correspondence, the opinion will be sent to the address indicated by the applicant.
If the product does not comply with the definition of the medicinal product, the ZVA does not determine which category it corresponds to.

If the product complies with the definition of medicinal products, such product must be registered in accordance with the requirements specified in the regulatory documents applicable to medicinal products in order to be distributed.
Payments: View payments
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Phone number: 67078424
Fax: 67078428
Other contact details:
Working time