Submission of Scientific Advice Application
What is scientific advice
The scientific advice is a procedure pursuant to Article 25 of the Medicinal Products Act (Official Gazette, No 76/13, 90/14 and 100/18), where HALMED advises pharmaceutical manufacturers or applicants/marketing authorisation holders on the appropriate pharmaceutical, non-clinical and clinical studies that need to be carried out for the purpose of granting or varying a marketing authorisation. Furthermore, the advice can be given on GMP and regulatory issues, pharmacovigilance activities, planned changes in labelling (mock-up) and package leaflet, changes to legal/dispensing status, proposals on medicinal product name and all other regulatory issues within the competence of HALMED. The scientific advice is given before initiation of a regulatory procedure, that is, it is focused on future activities and development of the applicant’s strategy, which is submitted to HALMED for consideration with application for scientific advice and supporting documentation. This procedure does not include assessment of the documentation foreseen by the applicant to be submitted in the future regulatory procedure. The main purpose of this HALMED's service is to accelerate the development and availability of medicinal products.
When to ask for scientific advice
The scientific advice may be requested at any time of a medicinal product development phase before the submission of an application for marketing authorisation or variation. The advice is sought before undertaking regulatory, pharmacovigilance or other activity associated with the development and life cycle of a medicinal product or group of medicinal products, in order to avoid additional questions and need for additional studies or other actions in the planned future procedure. It is recommended to seek HALMED’s scientific advice in case the applicant plans to deviate from the current scientific and professional guidelines on development, quality control and monitoring of medicinal products.
Questions and areas to which the scientific advice is usually related are:
- quality aspects (chemical, pharmaceutical and biological analysis required to demonstrate the quality of the medicinal product)
- non-clinical aspects (pharmacological and toxicological analysis required to demonstrate that the medicinal product is safe to use)
- clinical aspects (i.e. selection of endpoints, duration of clinical trial, target population, selection of reference medicinal product, etc.)
- pharmacovigilance plans and plans for post-marketing studies,
- meeting the requirements of Good Manufacturing Practice (GMP)
- various regulatory issues
- changes to the labelling of medicinal products
- changes in the legal/dispensing status of a medicinal product
- consideration of medicinal product name proposal.
How to submit an application for a scientific advice and what documentation to submit
The scientific advice procedure is initiated by a request submitted to HALMED through the HALMED Registry Office or to the e-mail address pisarnica@halmed.hr.
The following documents should be submitted with the application:
- request for scientific advice/cover letter in Croatian or English signed by an authorized person of the applicant
- completed application form for scientific advice in Croatian or English,
- list of questions with explanation by the applicant and reference to relevant documentation/literature
Note: As HALMED's opinion is requested on sufficiency of data and planed actions in a future regulatory procedure, the applicant should elaborate the proposed strategy and approach in details and substantiate them with appropriate scientific and regulatory regulations/guidelines as well as applicant's own data, when applicable. Questions should be prospective, concern the future planned activities and be clear and precise with sufficient details to provide response. - documentation/literature referred to by the applicant
- proof of payment as per HALMED's fees
Note: Before submission of the application, the applicant should send the request for a proforma invoice for the respective scientific advice to racunovodstvo@halmed.hr. The request should contain the following details:
- name of the medicinal product, active substance and/or area for which advice is sought
- name of the applicant, address and company registration number
- additional information, as needed.
Procedure after receiving an application for scientific advice
If HALMED determines, after receiving the respective application and supporting documentation, that additional information is needed to provide scientific advice, it will notify the applicant by e-mail, letter or, if necessary, arrange a meeting. Upon receiving the application, relevant experts are assigned who, based on the submitted explanation and documentation, propose answers to the questions and write the advice on the proposed strategy. The proposed advice is then considered at a meeting of the Committee for Medicinal Products or the Medicinal Products' Safety Committee.
HALMED provides the final scientific advice by an official letter addressed to the applicant. HALMED seeks to provide scientific advice within 60 days of receipt of the request, but it should be taken into account that the time required to give final advice depends on the complexity of the application, the amount of documentation that should be assessed and the need for consultations with the applicant and/or external experts.
With the final scientific advice, an invoice is issued as per HALMED’s fees. The fee is determined based on the number of working days spent on the assessment.
If up to three days are required for the assessment, the advice is considered a simple scientific advice.
If three to five days are required for the assessment, the advice is considered a complex scientific advice.
If more than five days are required for the assessment, the advice is considered an exceptionally complex scientific advice.
Scientific advice outcome
Irrespective of whether the scientific advice was sought before submission of a marketing authorisation application or its amendment, and regardless of the outcome of the scientific advice, a final opinion on the quality, efficacy and safety, regulatory approach or pharmacovigilance activities or other regulatory area covered by the advice, can be made solely on the basis of an assessment of the complete dossier of the medicinal product submitted with the marketing authorisation application/variation. HALMED's scientific advice does not replace or diminish the responsibility of manufacturers and applicants in future activities.
The scientific advice provided by HALMED is not binding to either HALMED nor the applicant for the purpose of medicinal product development and future marketing authorisation applications.
Contact
Procedural and scientific questions regarding the provision of scientific advice should be sent to the following e-mail address: advice@halmed.hr.
