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Decentralized 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

Advance payment for marketing authorisation shall be made based on the invoice in accordance with the Paid service pricelist of the State Agency of Medicines.

  • Article 6 of the Annex “Expertise on application and additional documentation for marketing authorisation of medicinal product via decentralised procedure where Latvia is the reference member state”
  • Article 8 of the Annex “Expertise on application and additional documentation for marketing authorisation of medicinal product via decentralised procedure where Latvia is the concerned member state”

The applicant shall:

1.Submit request for invoice (please see sample of invoice request here) by sending it to the following SAM e‑mail address: rekini@zva.gov.lv,

- Payment application
- Sample of payment application

2.Make payment after receipt of invoice from SAM – the invoice number and date, as well as name, surname or title of the payer must be indicated in the “purpose of payment”.

Requisites

State Agency of Medicines of Latvia
Jersikas street 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.