Decentralised marketing authorisation procedure
Via the decentralised marketing authorisation procedure medicinal products are authorised simultaneously in several European Union (EU) member states chosen by the marketing authorisation holder. Medicinal products authorised via the decentralised procedure have not been previously authorised in any of the EU member states. Summaries of product characteristics, package leaflets and labelling of medicinal products approved via the decentralised procedure include identical information in all of the member states where the medicinal product is authorised.
SAM evaluates the application for authorisation via the decentralised procedure within the terms stipulated by normative acts – within 210 days. The marketing authorisation procedure is carried out in accordance with EU legal acts and approved guidelines, as well as Cabinet of Ministers regulations regarding the procedure for marketing authorisation of medicinal products.
Submission of documents for marketing authorisation
- The application form and supporting documentation for marketing authorisation shall be submitted electronically using Common European Submission Portal (CESP), complying with the European guidelines on preparation and submission of documentation in the eCTD (electronic Common Technical Document) format.
- The application form is available here – eSubmission: EU Electronic Application Forms.
- Upon submission of documents, advance payment must be made and the following documents must be added to the marketing authorisation application:
- Copy of the invoice issued by the State Agency of Medicines (SAM);
- A payment confirmation or print-out of the payment made via internet bank transfer verified by the credit institution confirming the advance payment;
- SAM cash register check, if payment was made with a payment card.
See more in the section “Payment procedure”.
Within 7 days after completion of the decentralised procedure, translations of the product information (summary of product characteristics, package leaflet and labelling text) must be sent to this SAM e‑mail address: translations_mrp-dcp@zva.gov.lv.
Payment procedure
For this service advance payment should be made in accordance with the Paid Service Pricelist (Article 1, 2, 4):
Expertise on application and additional documentation for marketing authorisation of one medicinal product (Article 1):
- Application for a new active substance (Article 1.1.) - 4000,00 EUR
- Application for a medicinal product with well-established use (Article 1.2.) - 4000,00 EUR
- Application for marketing authorization of a medicinal product containing an active substance used in an authorized medicinal product, but not in this combination (application for a fixed combination) (Article 1.3.) - - 4000,00 EUR
- Application for a biosimilar medicinal product (Article 1.4.) - 4000,00 EUR
- Application for marketing authorisation where the marketing authorisation holder of the original medicinal product has given their approval for the marketing authorisation applicant to use pharmaceutical, non-clinical and clinical documentation included in the marketing authorisation documentation of the original medicinal product with an identical qualitative and quantitative active substance content and pharmaceutical form (Application with approval) (Article 1.5.) - 4000,00 EUR
- Application for a generic medicinal product (Article 1.6.) - 2500,00 EUR
- Mixed marketing authorisation application (Article 1.7.) - 2500,00 EUR
- Application for extention of marketing authorisation in accordance with Annex 1 of the European Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (hereinafter – Commission Regulation No. 1234/2008) (Article 1.8.) - 1500,00 EUR
- Application for a medicinal product with identical marketing authorisation documentation, but different names and one and the same or different marketing authorisation holder (repeat application, submitted simultaneously) (Article 1.9.) - 1500,00 EUR
- Application for a homeopathic or anthroposophic medicinal product, 1 pharmaceutical form or 1 strength (Article 1.10.) – 560,00 EUR
- Application for a traditional-use herbal medicinal product (for herbal medicinal products to be authorised via the simplified marketing authorisation procedure), 1 pharmaceutical form or 1 strength (Article 1.11.) – 560,00 EUR
Additional fee for each additional medicinal product strength and/or pharmaceutical form, if submitted together with the initial marketing authorisation application (Article 2), except stated in Article 1.10. and stated in Article 1.11.:
- Marketing authorisation (Article 2.1.) - 1000,00 EUR
Additional fee for performing tasks for Latvia as a reference member state in a mutual recognition or decentralised procedure (Article 4):
- For marketing authorisation (Article 4.1.) - 8500,00 EUR
- For repeat use mutual recognition procedure (RUP procedure) (Article 4.3.) - 2500,00 EUR
To receive the prepayment invoice, please send the Payment Application (download here) to e-mail: rekini@zva.gov.lv.
Following the submission of application, an invoice for advance payment shall be sent to the e-mail address you indicated.
Upon making payment, the invoice number and date, as well as name, surname or title of payer must be indicated in the “purpose of payment”.
State Agency of Medicines of Latvia
Jersikas iela 15, Riga, LV-1003, Latvia
VAT reg. No. LV90001836181
The Treasury of the Republic of Latvia
LV24TREL9290579005000
BIC TRELLV 22XXX
Application for decentralised procedures where Latvia is the reference member state – please see Authorization Procedure with Latvia as Reference Member State.
