Renewal of marketing authorisation
The decision regarding marketing authorisation of a new medicinal product stays in effect for five years after its adoption. After five years have elapsed since adoption of decision regarding marketing authorisation, a decision is adopted regarding renewal of authorisation, based on evaluation of the risk and benefit ratio. The State Agency of Medicines (SAM) may adopt a decision regarding renewal of authorisation for an unlimited period of time. If based on evidence from monitoring of adverse drug reactions, SAM is of the opinion that another renewal is required, it may adopt a decision to renew authorisation for another five years. In order to reach a common renewal date among the member states involved in a mutual recognition procedure, the marketing authorisation of the relevant medicinal product may be renewed before five years have elapsed. Please see more information here.
The renewal procedure is conducted in accordance with the European Union (EU) legal acts and approved guidance, as well as the Cabinet of Ministers regulations regarding the procedure for marketing authorisation of medicinal products.
The application for renewal of marketing authorisation must be submitted to SAM at least 9 months prior to the expiration date of the marketing authorisation of medicinal product.
The application for renewal of marketing authorisation granted via the national procedure must be submitted to SAM. If the medicinal product is authorised through the mutual recognition procedure or decentralised procedure, the application for renewal must be submitted simultaneously to the reference member state and all of the concerned member states.
Submission of documents for renewal of marketing authorisation
- The application form and supporting documentation for renewal of 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 renewal of 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 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 renewal of marketing authorisation via the Common European Submission Portal (CESP) without parallel submission of 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.
If the mutual agreement between SAM and the marketing authorisation holder is not signed and the renewal 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 renewal;
- 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 email@example.com, 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, LV‑1003.
- Parallel to submission of application for renewal of 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.
- After completion of renewal procedure within the mutual recognition procedure, translations of product information (summary of product characteristics, package leaflet and labelling text) must be sent to the following SAM e‑mail address firstname.lastname@example.org within 7 days.
Variations to the medicinal products authorisation documentation
After a medicine has been authorised, the terms of the marketing authorisation may subsequently be varied, including:
· Administrative changes (name of the company and/or address)
· Quality changes
· Changes regarding safety, efficacy and pharmacovigilance
Variation notifications are defined as minor Type IA variations, minor Type IB variations or major Type II variations.
Frequently asked questions regarding variations.