Translated using Hugo.lv
Receipt of scientific advice
Selected Organization: Zāļu valsts aģentūra
Brief description:
Scientific advice on issues related to the development of medicinal products, registration applications, clinical trial applications, aspects of regulators.
Consultations may also be requested during the development of medicinal products in order to clarify the issues concerning applications for registration/clinical trials of medicinal products or the requirements of the guidelines.
Beneficiaries:
Legal persons governed by public law, Private law legal persons
Pharmaceutical companies, the owners or potential owners of a marketing authorisation for medicinal products,
Academic or research institutions, Health Care Institutions.
Period:
Scientific advice (document with answers to each question) will be provided within 8 weeks of receipt of payment and full documentation.
Process description
Documents and forms
Other information
1. solis / Service Offices
Scientific advice may be provided in relation to the following areas:
• quality aspects (e.g. manufacturing of the active substance/medicinal product, choice of raw materials of the active substance, chemical, pharmaceutical testing, stability);
• non-clinical aspects (toxicological and pharmacological tests);
• clinical development (e.g. study design, objectives, comparable medicinal products, study population);
• aspects of pharmacovigilance (risk management plan, risk minimisation measures);
• general issues concerning regulators (e.g. application of guidelines, choice of legal basis for registration of medicinal products or type of procedure for registration of medicinal products, etc.);
• cost-effectiveness aspects.

Consultations may be provided at any stage of development of the medicinal product, prior to registration, re-registration of the medicinal product or prior to the submission of an application for registration of a change in the dossier. Consultations may also be provided during the post-marketing period of the medicinal product.

In order to receive scientific advice, it is necessary to submit to the State Agency of Medicines (ZVA) an “application for the possibility of obtaining scientific advice”.

Type of submission:
- an e-signed Application shall be sent to an e-address or e-mail: info@zva.gov.lv.
Payments: View payments
An e-service in authorities home page Zva e-address
2. solis / Assessment of the service application
Within seven (7) days, a reply will be sent to the email address provided by the applicant for the service regarding the possibility of the ZVA providing scientific advice.

If the ZVA agrees to provide advice, the applicant for the service will receive an invoice and a request to send the full documentation required for the provision of the service to the ZVA via THE CESP platform or to the info@zva.gov.lv e-mail address
Payments: View payments
3. solis / A service charge
The fee for the service shall be performed in accordance with the schedule of fee services of the State Agency of Medicines:

1. Scientific advice on matters relating to the procedures for the registration of medicinal products, including changes to the procedures for the registration of medicinal products, EUR 2000,00 (point 8.1);

2. Scientific advice on preclinical, clinical, pharmacovigilance, pharmaceutical aspects and cost-effectiveness issues – EUR 7000,00 (point 8.2).

Properties
State Agency of Medicines
Jersika Street 15, Riga LV-1003
Sales tax exempt. No. LV90001836181
The TREASURY
LV24TREL9290579005000
BIC TRELLV 22XXX
Payments: View payments
4. solis / Receipt of services
The scientific advice (a document with answers to each question asked by the applicant for the service) will be sent to the email address indicated by the applicant within eight (8) weeks of receipt of the payment and full documentation.

If the applicant has any questions after obtaining the advice (reply) of the ZVA, the applicant may ask for additional clarification of the advice provided by the ZVA, but the conclusions of the consultation will not be re-examined.
Payments: View payments