On the basis of Article 29 of the Medicinal Products Act (Official Gazette of the RS, No 17/2014), the applicant may ask JAZMP for guidelines and advice regarding the drafting and technical contents of the application.
The applicant may ask for advice for any medicinal product, irrespective of the further choice of procedure.
The applicant may request advice on matters relating to the contents of the medicinal product documentation or on regulatory matters.
Advice on the scientific contents of the documentation in further processing of the application is binding neither for JAZMP nor for the applicant. Neither is the role of JAZMP to take upon itself the responsibility of the pharmaceutical industry for the development of their products.
REQUEST FOR ADVICE
The request must contain the following data:
- name of the medicinal product, active ingredient (ATC code) and pharmaceutical form;
- which area of expertise covers this issue (e.g. pharmaceutical-chemical, pharmaceutical-biotechnological, preclinical, clinical, pharmacokinetical, regulatory);
- contact data of the applicant;
- how/in what way the applicant wishes JAZMP to provide guidance and advice (meeting, teleconference/videoconference or in writing);
- scientific issue(s) and the applicant’s standpoint regarding the issue(s) in question
JAZMP will inform the applicant as soon as possible whether they can provide expert advice for the issue in question.