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Mutual recognition procedure

Mutual recognition authorisation procedure

 

The medicinal product is authorised in one country and then simultaneously in several other countries of marketing authorisation holder’s choosing. The first country to issue marketing authorisation becomes the reference member state. The other countries involved in the procedure become the concerned member states. The text of summaries of product characteristics, package leaflets and labelling of a medicinal product authorised via the mutual recognition procedure includes identical information in all of the countries where the medicinal product is authorised.

After completion of the first mutual recognition or decentralised procedure, the marketing authorisation holder may use the Repeat Use Procedure in order to authorise the medicinal product and receive marketing authorisation in other European Union (EU) member states.

The State Agency of Medicines evaluates applications for marketing authorisation of medicinal product via the initial/repeat mutual recognition procedure within the terms stipulated by normative acts – within 60 or 90 days. The marketing authorisation procedure is conducted in accordance with the EU legal acts and approved guidance, as well as the Cabinet of Ministers regulation regarding the procedure for marketing authorisation of medicinal products.

Submission of documents for marketing authorisation

  • The application form and accompanying documentation for marketing authorisation shall be submitted electronically in compliance 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 for marketing authorisation, an advance payment must be made and the following documents shall be added to the marketing authorisation application:
    a) Copy of the invoice issued by the State Agency of Medicines (SAM);
    b) A payment confirmation or print-out of the payment made via internet bank transfer verified by the credit institution confirming the advance payment;
    c) 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.

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 additional 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 street 15, Riga, Latvia‑1003.

 

Within 7 days after completion of the first/repeat mutual recognition procedure, translations of the product information (summary of product characteristics, package leaflet and labelling text) should 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 5 of the Annex “Expertise on application and additional documentation for marketing authorisation of medicinal product via mutual recognition procedure where Latvia is the reference member state”
  • Article 7 of the Annex “Expertise on application and additional documentation for marketing authorisation of medicinal product via mutual recognition 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 first/repeat mutual recognition procedure where Latvia is the reference member state