Translated using Hugo.lv
Registration of medicinal products for human use
Selected Organization: Zāļu valsts aģentūra
Brief description:
Registration of medicinal products is necessary to ensure the availability of safe, high-quality and effective medicinal products to the public.
In order to register a medicinal product, the next owner of the Marketing Authorisation must choose the legal basis for the medicinal product (full application; bibliography, generic or mixed application; similar biological medicinal products; fixed combination; application with consent; homeopathic medicinal product or herbal medicinal product) and registration procedure (decentralised procedure, mutual recognition procedure). procedure, national procedure or centralised procedure).
Beneficiaries:
Private law legal persons
Period:
Depending on the type of registration procedure: 60/90/210 days
Process description
Documents and forms
Other information
1. solis / Service requests
The form of the application and the supporting documentation for registration of medicinal products must be submitted electronically, in accordance with the European guidelines for the establishment and submission of dossiers in the format of the eCTD (electronic Common Technical Document).
The prepayment for registration of medicinal products shall be performed in accordance with the invoice, in accordance with the price list of fees of the State Agency of Medicines.
In order to submit documents for registration of medicinal products to the European Common Register of Medicinal Products Portal (CESP) without submitting in parallel the cover letter and the original form of the application, the owner of the Marketing Authorisation must sign a mutual agreement with the State Agency of Medicines regarding the consent to the recognition of the documents submitted BY THE CESP without the original signature.
Documents to be submitted
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
Other electronic channels Common European Submission Portal (CESP) -
https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f
2. solis / A service charge
Procedures for Settlement

This service shall be prepayed in full in accordance with the State Agency of Medicines Charge Service Price List (1, 2, 4):
1) an expert-examination of the application for registration of medicinal products and the attached documentation for one medicinal product (p. 1):
• Application for medicinal products with a new active substance (1.1 p) - 4000,00 EUR
• application for medicinal products of general medical use (1.2 p.) - EUR 4000,00
• application for registration where the medicinal product contains active substances used in the registered medicinal product but not used in such combination (application for a fixed combination) (1.3 p.) - EUR 4000,00
• Application for similar biological medicinal products (1.4 p.) - EUR 4000,00
• application for registration in which the owner of the registration of the original medicinal product has agreed that the applicant for registration of medicinal products uses pharmaceutical, non-clinical and clinical documentation, which is included in the registration documentation of the original medicinal product, which contains the same qualitative and quantitative composition of the active substances and the same type of medicinal product (application with consent) - EUR 4000,00
• Exercise for generic medicines (1.6 p.) - EUR 2500,00
• mixed registration application (1.7 p) - EUR 2500,00
• Application for extension of the authorisation of medicinal products in accordance with Annex 1 to Regulation (EC) No 1234/2008 of the European Commission of 24 November 2008 concerning the examination of modifications to the conditions of marketing authorisations for medicinal products for human use and veterinary medicinal products (1.8 p.) - EUR 1500,00
• Application for medicinal products with identical registration documentation, but with different names of medicinal products and the same or different registration holder (multiple application at the same time) (1.9 p.) - EUR 1500,00
• Application for homeopathic or anthropogenic medicinal products per pharmaceutical form or per medicinal product strength (1.10 p.) - EUR 560,00
• Application for traditional herbal medicinal products (plant medicinal products to be registered in the simplified registration procedure) per pharmaceutical form or per medicinal product strength (1.11 p.) - EUR 560,00
2) an expert-examination of the submission and documentation regarding each additional submission of one strength of medicinal products and/or pharmaceutical form, if submitted at the same time as the initial application for registration of medicinal products (p. 2), except for homeopathic or anthropogenic medicinal products for one pharmaceutical form or for one medicinal product strength (1.10 p.) and traditionally used herbal medicinal products (in the simplified registration procedure) for herbal medicinal products to be registered) for one pharmaceutical form or for one medicinal product strength (1.11 p.):
• Marketing of medicinal products (2.1) - EUR 1000,00
3) ensuring the mutual recognition or decentralised procedure, if Latvia is the reference country (p. 4):
• Marketing of medicinal products (4.1) - EUR 8500,00
• Re-recognition procedure (RUP procedure) (4.3 p) - EUR 2500,00
To receive a prepayment invoice, please send your payment application (download here) to email: rekini@zva.gov.lv. After you have received a payment application, we will send an invoice to the email address you specified. When you pay a prepayment invoice, you must specify the number and date of the prepayment invoice 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
Documents to be submitted
Payments: View payments
3. solis / Receipt of services
The service is received in accordance with the application of choice.


Information regarding medicinal products shall be included on the website of the State Agency of Medicines: Latvian Register of Medicinal Products.
Information on the public register
Payments: View payments