From November 18th, 2013, Latvia will ensure submission of marketing authorisation documentation of medicinal products in the Common European Submission Platform (CESP)

From November 18th, 2013, Latvia will ensure submission of marketing authorisation documentation of medicinal products in the Common European Submission Platform (CESP)

The State Agency of Medicines (hereinafter - Agency) informs that starting from November 18th, 2013, the Agency will join the Common European Submission Platform (CESP) for submission of marketing authorisation documentation of medicines. In the portal Agency clients will be able to submit marketing authorisation documentation of medicines simultaneously to all the chosen medicines agencies of European Union (hereinafter - EU) member states.

When submitting documents for marketing authorisation, renewal, variations or response documentation and additional documentation, the eCTD and Non-eCTD format must be used. In addition to the documentation submitted in CESP the following documents must be submitted to the Agency directly:

1. an originally signed cover letter,
2. an originally signed application form for marketing authorisation, renewal or variations,
3. a proxy (if not submitted to the Agency before),
4. a copy of SAM invoice and a payment confirmation containing the number of the invoice issued by the Agency.

The documents must be submitted in accordance with the current normative acts of the Republic of Latvia, therefore, the documents must be signed with a secure electronic signature or the original document must be submitted in paper format.

→ The documentation may be submitted in the following ways:

Option No. 1
Via e-mail info@zva.gov.lv with attached secure electronic signature (created using a secure electronic signature formation method and confirmed with a 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.

→ The Agency will begin examination of the documentation submitted for marketing authorisation, renewal or variations only after receiving the aforementioned document and advance payment

→ Advance payment must be made according to the invoice issued by the Agency

1. Submission of payment notification (see attached form). 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).
2. 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.
3. Upon submitting documents for marketing authorisation, renewal or variations the following documents must be attached to the package of documents:
   • 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
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

CESP complies with the requirements of the European Medicines Agency (hereinafter - EMA) 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: cesp.hma.eu/Home