Translated using Hugo.lv
Assessment of the product documentation on its compliance with the definition of medicinal products
Selected Organization: Zāļu valsts aģentūra
Brief 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
Period:
Within 2 months
Process description
Documents and forms
Other information
1. solis / Service requests
In order to receive an opinion regarding the conformity of the product with the definition of medicinal products, the applicant for an opinion must submit an application to the ZVA, accompanied by the documents and data listed in paragraph 127 of Regulation No 376 of the BOM:
• 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 quantities of the product;
• recommended daily dose;
• the type and size of the packaging;
• labelling text;
• a model of the instructions for use;
• other information materials about the product under consideration.

Types of submission

Documents may be submitted electronically at the address of info@zva.gov.lv or ZVA if they have been signed with a secure electronic signature, indicating “Product compliance with the definition of medicinal products” and the name of the product in the subject box.

For information on a secure electronic signature, see: https://www.eparaksts.lv/lv/

The transmission of documents in the ZVA e-address does not confer legal force on the document, but only guarantees its delivery. The documents submitted in the Zva e-address must be signed with a secure electronic signature, similar to what would be done through other communication channels, such as e-mail.

If the referred to documents have not been completed in conformity with the regulatory enactments regarding the drawing up of electronic documents, they must be submitted in paper format to the ZVA customer service centre, office 11 (address: Jersik Street 15, Riga, LV-1003), also sending the electronic version of the documents to the e-mail in the info@zva.gov.lv section of the subject, indicating “Product Match for the definition of medicinal products” and the product, confirming in the e-mail that the documents submitted electronically are the same as those submitted in ZVA paper format
Payments: View payments
An e-service in authorities home page Zva e-address
On the spot State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details: Klientu apkalpošana 11. kabinets.
Working hours
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details:
Working hours
2. solis / A service charge
Procedures for Settlement

This service should be prepayed in full according to the State Agency of Medicines Charges Schedule (9. p.) - EUR 650,00.

Upon receipt of the application, the ZVA shall send a prepayment invoice for payment to the e-mail address specified in the application. When you pay a prepayment invoice, you must specify the number and date of the prepayment invoice in the payment target.

After providing an opinion, the ZVA shall send the invoice to the e-mail address indicated in the application as a statement for the performance of the service.

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
Assessment

Each product is evaluated separately on the basis of relevant regulatory documents, the latest scientific literature, etc. available information. The decisions of the European Court of Justice in similar cases are also taken into account.

In assessing all product characteristics, particular account shall be taken of:
• qualitative and quantitative composition;
• pharmacological, immunological and metabolic properties to the extent that they can be ascertained according to the latest scientific knowledge;
• the type and form of administration and the fact that a similar product is registered as a medicinal product;
• consumer awareness;
• risks associated with the use of the product;
• Product information (labelling, package leaflet, promotional materials and other product information).

Receipt of an opinion

An opinion on whether the product concerned complies with or does not comply with the definition of the medicinal product shall be delivered by the ZVA within two months of receipt of the application and prepayment, without including the time required for the receipt of additional information.
An opinion regarding the conformity of the product with the definition of medicinal products specified in the Pharmaceutical Law shall be delivered electronically by sending it to the e-mail address indicated in the submission of the applicant for an opinion. If the applicant for an opinion wishes to obtain an opinion in paper form, the ZVA shall be informed thereof, which, after preparing the opinion, will send it to the applicant's registered office within five working days or, if the applicant has indicated another 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 - in order to be distributed, this product must be registered in accordance with the requirements specified in the regulatory documents applicable to medicinal products.
Payments: View payments
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details:
Working hours