National marketing authorisation procedure for medicinal products
Via the national marketing authorisation procedure medicinal products are authorised only in Latvia. By authorising medicinal products through this procedure, the marketing authorisation is valid only in Latvia, therefore, the medicinal product may be distributed only in Latvia.
The State Agency of Medicines (SAM) evaluates the application for marketing authorisation in the national authorisation procedure in accordance with the terms of normative acts – for the majority of applications it is stipulated that marketing authorisation shall be completed within 210 days following positive primary expertise. The marketing authorisation procedure is conducted in accordance with the European Union (EU) legal acts and Cabinet of Ministers regulation regarding the procedure for marketing authorisation.
However, in order to authorise a medicinal product only in Latvia, the applicant may not always use the national authorisation procedure:
- There is a category of medicinal products subjected to the centralised authorisation procedure as stipulated by EU legal acts [Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004], therefore, these medicinal products may not be authorised via the national authorisation procedure.
- A medicinal product may not be authorised in a national authorisation procedure if the same applicant has already received a marketing authorisation in another EU/EEA Member State or has already submitted an application for marketing authorisation in another EU/EEA Member State and the application is undergoing evaluation. In such a case, the applicant must use the mutual recognition procedure or decentralised procedure.
Submission of documents for marketing authorisation
- As of 1 July 2018, application forms and supporting documentation for marketing authorisation of medicinal products must be submitted electronically complying with the European guidelines for preparation and submission of documentation in the eCTD (electronic Common Technical Document) format.
- The application form is available on eSubmission: EU Electronic Application Forms.
- Upon submission of documents for marketing authorisation, an advance payment must be made and the following documents must be attached 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”.
- In order to submit documents for marketing authorisation via the Common European Submission Portal (CESP) without also submitting cover letters and the original application form, the marketing authorisation holder must sign a mutual agreement with SAM regarding recognition of the documents submitted via CESP without an original signature.
A document (copy of the document) proving the power of signature for the signatory must be submitted to SAM along with the signed agreement.
If the mutual agreement between SAM and the marketing authorisation holder is not signed and marketing authorisation documents are submitted via CESP, the original documents must be submitted to SAM (submission of original documents is not required when submitting additional documentation):
- Signed cover letter, indicating the CESP number;
- Signed application for marketing authorisation;
- Attorney of power, if not submitted to SAM previously;
- Copy of the invoice issued by SAM and confirmation of payment.
Original documents must be submitted in accordance with the requirements of the current normative acts in Latvia and they must be signed with a secure electronic signature (Option 1) or in paper format (Option 2):
Option 1: When using the e‑mail address: firstname.lastname@example.org, please sign the letter with a secure electronic signature (created with a secure method for creating an electronic signature and verified with a qualified certificate). Size limit of one e‑mail – 10 MB.
SAM accepts documents signed with secure electronic signatures from other countries if the authenticity of the signature can be verified. Information (instruction, link to website) on how to open the document and verify the authenticity of the electronic signature must be supplied together with the document.
Option 2: Paper format documentation may be submitted to SAM in person (Room 11) or sent via mail to SAM address: Jersikas iela 15, Riga, LV‑1003.
- Parallel to submission of application for marketing authorisation via the national procedure, product information (summary of product characteristics, package leaflet and labelling text) in Latvian and in Word format must be sent to the following SAM e‑mail address: NP_PI@zva.gov.lv.
For this service advance payment should be made in accordance with the Paid Service Pricelist (Article 1, 2):
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 expansion 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
To receive the prepayment invoice, please send the Payment Application (download here) to e-mail: email@example.com.
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
BIC TRELLV 22XXX