| | Latvia ensures receipt of marketing authorisation documentation for medicinal products through the common European document submission platform CESPThe State Agency of Medicines (hereinafter - Agency) informs that it has joined the Common European Submission Platform (CESP) for submission of marketing authorisation documentation for medicines. Through this platform Agency clients are able to submit marketing authorisation documentation simultaneously to all the chosen medicines agencies of the European Union (hereinafter - EU) member states. Document submission through CESP is not mandatory, other options for submission of documents may still be used (also within the life cycle of a medicinal product). The Agency accepts documents through CESP:
(if documents are submitted through CESP, duplications are not allowed by submission of documents in CD/DVD format or through Eudralink) | Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), National Authorisation Procedure (NP) | Centralised Authorisation Procedure (CAP) |
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| Only for marketing authorisation, renewal, variation or response documentation upon request and additional documentation | All types of marketing authorisation documentation (marketing authorisation, renewal, variations, PSUR, PMF, DMF and others) | | Only eCTD/Non-eCTD format | Only eCTD/Non-eCTD format | In addition to the documentation submitted through CESP the original documents must be submitted separately: For a new application:
- a signed cover letter indicating CESP number,
- a signed application form for marketing authorisation, renewal or variations,
- a power of attorney, if not submitted to the Agency previously,
- a copy of SAM invoice and a payment confirmation containing the number of the invoice issued by the Agency.
When submitting additional documentation a signed cover letter must be submitted. The Agency shall begin review of documentation only after receiving the original documents and advance payment! | Not necessary |
The original documents shall be submitted in accordance with the normative acts in force in the Republic of Latvia, therefore, they have to be signed with a secure electronic signature or signed in paper format: Option No 1
A letter sent via e-mail info@zva.gov.lv must be signed with a secure electronic signature (created using a secure electronic signature formation method and confirmed with a quality certificate). Size limit of one e-mail is 10 MB. Option No 2
The signed documentation in paper format may be submitted in the Agency in person or it may be sent via mail to Zāļu valsts aģentūra, Jersikas ielā 15, Rīgā LV-1003, Latvijā.
Advance payment must be made in accordance with the invoice issued by the Agency - Submission of payment notification:
The form may be submitted electronically (rekini@zva.gov.lv), via mail or in person at the Agency (Jersikas street 15, Riga), in the Financial Accounting, Analysis and Planning Department (Room 59). - After receiving the payment notification the Agency will issue an invoice. Upon making payment, the invoice number and date must be indicated in the “purpose of payment” section of the payment task.
- Upon submitting documents for marketing authorisation, renewal or variations the following documents must be attached to the package of documents:
- an invoice copy;
- a payment task verified by the credit institution or a payment task printed out through the internet banking service of the credit institution verifying the payment transaction.
- The first name and surname or title of the payment maker must be clearly indicated in the payment task and the payment task must be signed by the payment maker.
- If the payment is made with a payment card, the check issued by the Agency must be indicated.
Requisites
Zāļu valsts aģentūra
Jersikas iela 15, Rīga LV-1003
PVN reģ. Nr. LV90001836181
Valsts kases Rīgas norēķinu centrs
LV24TREL9290579005000
BIC TRELLV 22 CESP complies with the requirements of the European Medicines Agency and EU national medicines agencies and marketing authorisation holders, thus, it can ensure common receipt of data and information. Joining the portal will ensure receipt of documents from marketing authorisation holders in mutual recognition and decentralised marketing authorisation procedures, thus, minimising the administrative burden and ensuring the possibility to submit common documentation electronically to all the chosen EU member states simultaneously. The Irish Medicines Board ensures the use and maintenance of the CESP portal. Further information regarding CESP is available here. |
