Instructions for Submitting Applications for Scientific Advice
What is scientific advice?
The scientific advice is a procedure where HALMED advises pharmaceutical manufacturers or applicants/marketing authorisation holders about respective pharmaceutical, non-clinical and clinical investigations that need to be carried out for the purpose of granting marketing authorisation, variation, regulatory issues, pharmacovigilance actions, planned modifications in labelling and package leaflet, Rx-to-OTC switches, changes in dispensation site product name proposals. The scientific advice is directed towards future activities or strategy development of the applicant that is to be submitted by an application and/or documentation to HALMED for consideration. This procedure does not include assessment of the documentation foreseen by the applicant to be submitted in the future. The main purpose of this HALMED's service is to accelerate the medicinal products development and availability.
When to ask for scientific advice?
The scientific advice may be requested in any medicinal product development phase; prior to submitting an application for marketing authorisation or variation, or prior to undertaking certain regulatory, pharmacovigilance or other activities associated with the development and life cycle of medicinal product or group of medicinal products in order to avoid additional questions and need for additional studies and other actions in the planned future procedure. It is strongly recommended to ask for a HALMED's scientific advice in the case where the applicant plans to deviate from the current scientific and technical guidelines in development, quality control and medicines monitoring.
Questions and areas to which the scientific advice is usually related are as follows:
- quality aspects (chemical, pharmaceutical and biological analysis needed for proving the quality of the medicine),
- non-clinical aspects (pharmacological and toxicological analysis needed to prove the safe use of the medicine,
- clinical aspects (i.e. end points, duration of clinical trial, target population, selection of reference medicinal product, etc.)
- pharmacovigilance plans and plans for post-marketing studies,
- various regulatory issues,
- changes in labelling,
- Rx-to-OTC switch and changes in dispensation site,
- consideration of product name.
How to apply for a scientific advice and which documentation to attach?
In order to obtain a scientific advice, an application should be submitted to HALMED.
When applying for a scientific advice, the following documents should be submitted:
- official cover letter signed and sealed by the applicant's responsible person,
- completed application form,
- explanation of the application and list of questions with reference to relevant documentation/literature,
Note: By scientific advice, it is asked from HALMED an opinion on sufficiency of data and planed actions in some future procedure and therefore it is necessary to elaborate the proposed strategy and approach in details and substantiate it with scientific and regulatory regulations and guidelines as well as own data when applicable. Questions should be prospective in character and should refer to the future, planned activities and be as clearer as possible and precise and contain sufficient details for providing answers.
- • documentation/literature to which the applicant refers (guidelines or i.e. own data such as descriptions of clinical trials that are planned to be implemented, if an advice about the clinical data sufficiency for proving the medicine's efficacy is requested),
Note: The scope of documentation should be restricted to essential information, whereas the comprehensive documentation corresponding to the entire and/or parts of CTD format and the documentation containing the additional data, except those regulated by respective guidelines are not recommended for submission.
- confirmation of payment in accordance with the HALMED's price list
- others as needed.
Procedure after receipt of the application for scientific advice
If after submission of the respective application and accompanying documentation, HALMED considers that additional information for providing scientific advice is needed, the applicant will be notified by e-mail, letter or invited to a hearing. When receiving the application, respective experts are allocated that based on the submitted explanation and documentation propose answers to questions on the list and provide a written opinion about the proposed strategy. As needed, the opinion is discussed at the Medicinal Products Committee's meeting.
HALMED provides the final scientific advice by an official letter addressed to the applicant. HALMED will provide the scientific advice as soon as possible, but it should be taken into account that the final opinion depends on the complexity of the application, amount of documentation that should be assessed and need for consultations with the applicant and/or external experts.
Scientific advice outcome
Regardless whether the scientific advice is requested before submitting an application for granting the marketing authorisation and regardless of the outcome of scientific advice, the final opinion on the quality, efficacy and safety, regulatory approach or pharmacovigilance actions may be granted solely based on the assessment of the full s documentation of medicinal product that is to be attached to the official application. The HALMED's scientific advice does not substitute or reduce the manufacturer's and applicant's responsibility in future activities.
The scientific advice provided by HALMED is not binding neither to HALMED nor to the applicant in future procedures.