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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: email@example.com.
Documents to be submitted