The aim of providing scientific or regulatory advice by the State Agency of Medicines of Latvia (hereafter – Agency) is to assist applicants in the development and licensing of new or existing safe, effective and high quality human medicinal products, for the benefit of patient health. This advice focuses on development strategies rather than pre-evaluation of data that might be submitted in any future applications.
The advice is available on request for commercial and non-commercial (e.g. academic institutions or clinical trial investigators) entities concerning scientific development, marketing authorization applications, clinical trial applications, regulatory matters or a combination of these. Advice can be requested to clarify application or deviation from guidelines in development of medicines.
The advice can be requested at any stage of the initial development of a medicine, before submission of a marketing authorisation and during the pre-submission period for a renewal or variation to an existing marketing authorisation. Advice can be sought also in post-authorization phase.
The advice given is based on the questions and documentation submitted by the applicant considering current relevant scientific and regulatory knowledge and does not reflect any future developments. Applicants seeking scientific or regulatory advice must be aware that any advice given is not legally binding for any future marketing authorisation applications or HTA for the medicine concerned. The provided advice cannot substitute the applicant’s responsibilities in the development of its medicinal product. The Agency will not provide preliminary dossier assessment for future applications.
The advice is provided in written form. In exceptional cases a discussion meeting might be possible before applying for the advice or after receiving the Agency’s advice. The applicant can request a meeting via email indicating specific questions for discussion.
Types of advice
Scientific or regulatory advice can be given on questions related to:
- Quality aspects (e.g., active substance/ drug product manufacturing, choice of starting materials, chemical, pharmaceutical testing, stability)
- Non-clinical aspects (toxicological and pharmacological tests)
- Clinical development (e.g. study design, endpoints, choice of comparator, study population)
- Pharmacovigilance issues (risk management plans, risk minimisation measures)
- Non-specific regulatory questions (e.g. application of guidelines, selection of legal bases or procedural type, changes in legal status etc.)
The Agency will not provide scientific advice on development of medical devices, radiopharmaceutical products, homeopathic products, vaccines and quality aspects of inhaled medicines.
Questions submitted for the scientific or regulatory advice need to be specific and precise. The Agency will provide advice only to specific questions submitted by the applicant. Each question should be followed by the applicant’s position and justification together with cross references to the relevant documentation. In addition, the applicant is requested to submit up to date documentation (e.g. background information, relevant study protocols, guidelines, previous scientific advice).
Please note that the Agency will continue to respond to non-scientific regulatory questions such as which documents need to be submitted or how to group variations without specific applications or charges.
Requesting scientific advice
- Complete and submit the Application Form. Please send it to email@example.com in the subject line indicating Scientific advice and product name.
- Within 7 days you will be notified to the specified email address if the application can be accepted.
- If the Agency accepts to provide the advice, you will be sent an invoice and asked to send complete documentation via CESP or by email to firstname.lastname@example.org.
- The scientific advice (a report providing answers to each question) will be sent to you via email to the specified email address within 8 weeks after payment and complete documentation is received.
- If the applicant has additional questions after the advice is provided by the Agency, further clarification may be requested regarding the advice issued, however, the advice will not be reviewed again.
- Regulatory advice 2000 EUR
- Scientific advice on non-clinical, clinical, pharmacovigilance, pharmaceutical issues and pharmacoeconomic questions 7000 Eur
For details please see the Paid Service Price List.