Translated using Hugo.lv
Registration of the manufacturer, distributor and importer of active substances (change)
Selected Organization: Zāļu valsts aģentūra
Brief description:
Active substances used for the manufacture or manufacture of medicinal products for human use in a pharmacy must register pharmaceutical activity for the performance of manufacturing, distribution or import activities and obtain a registration certificate.
In case of changes, it is necessary to submit information to the State Agency of Medicines regarding the changes that have occurred.
Beneficiaries:
Legal persons governed by public law, Private law legal persons
Legal person of public law or private law, who has registered in the Enterprise Register of the Republic of Latvia, deals with pharmaceutical activity
Period:
Pharmaceutical Law or the Administrative Procedure Law, within the time limit specified in the special legislation (30-120 days)
Process description
Documents and forms
Other information
1. solis / Service requests
In order to register his or her type of activity or to inform about the changes, the State Agency of Medicines (SAM) “Application for the Registration of Importers, Producers and Distributors of Active Substances” should be submitted.

Types of submission:
- e-signed e-mail application: info@zva.gov.lv.;
- SAM in the Customer Service Centre (Jersik Street, 15, Riga, 11 th Cabinet);
- by post (address: Jersik Street 15, Riga, LV-1003).
Payments: View payments
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

After receipt of the documents, an invoice regarding the expert-examination of the documentation will be sent to the SAM to the e-mail address indicated in your submission, in accordance with the SAM fee service schedule (p. 32):

- the first (one) produced, imported or redistributable active substance (1 dossier expert-examination) (32.1 p.) – EUR 100,00

- each subsequent active substance manufactured, imported or redistributed (1 dossier expert-examination) (32.2 p.) – EUR 20,00

If in relation to the registration of a merchant it is necessary to perform an inspection (inspections), an additional invoice shall be prepared regarding the performance thereof in accordance with the fee service schedule of the SAM (35. p.):

- first day of inspection (35.1 p) - EUR 2000,00

- the next day of each inspection (35.2 p) - EUR 1000,00

If the performance of the examination is related to the outing of experts of the SAM, the merchant shall, in accordance with Paragraph 9 of Regulation No 641, cover the expenses of the SAM in relation to the outing necessary for the performance of the examination.

After providing the service, we will send an invoice to the specified email address. When you pay an invoice, you must specify the invoice number and date in the payment target.

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
The registration certificate for active substances may be obtained in the form of an electronic document.

If the applicant wishes to obtain a paper-based registration certificate for active substances, the SAM should be informed thereof, which, after taking the decision, will send it to the applicant's registered office or, if the applicant has indicated a different address for correspondence, the certificate will be sent to the address indicated by the applicant.

The certificate can only be obtained after the invoice has been paid.

The SAM shall enter the information in the Eudra GMDP database within three working days after taking a decision on the registration of the manufacturer, importer or distributor of active substances.

Information on the active substance for production, import and distribution to registered persons is available on the website of the SAM in the list of manufacturers, importers and distributors of the registered active substances.
Payments: View payments
Mail State Agency of Medicines
Adrese: Jersikas iela 15, Rīga, LV-1003
Tālrunis: 67078424
Fakss: 67078428
Other contact details:
Working hours
Another https://www.zva.gov.lv/