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Decentralised procedure

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 authorised 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, 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”.

In order to submit documents for marketing authorisation via the Common European Submission Portal (CESP) without submitting cover letters and the original of the 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.

 

 The agreement form

 

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 supplementary documentation):

  1. Signed cover letter, indicating the CESP number;
  2. Signed application for marketing authorisation;
  3. Attorney of power, if not submitted to SAM previously;
  4. 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 info@zva.gov.lv, 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, Latvia‑1003.

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 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

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

 

 

Additional information

 

Application for decentralised procedures where Latvia is the reference member state – please see Authorization Procedure with Latvia as Reference Member State.

Multilingual packaging and Baltic package procedure