Brief description of local requirements.
1. How long does it take to do RMP educational materials application to Local health authority?
Application procedure – once you have translated educational material in graphic design you send educational material together with distribution plan to authority for evaluation. Authority has example of cover letter for educational materials and has example of distribution plan template in local language
Educational material should be submitted at least 2 months prior distribution.
Slovak authority requires to submit EM at least 3 months prior distribution. EM in Slovakia needs to be submitted by local representative since approved version of EM will be sent to national emal gateway.
2. How long it takes to be reviewed and get approval? Educational material should be submitted at least 2 month prior distribution. There is no specific deadline stated in guideline but it is written that SÚKL will response in timely manners.
3. Is there any specific local guideline for RMP educational plans and materials related with Pecfent/fentanyl or general? Guideline PHV-7 version 2 SÚKL requirements for the development, content, and distribution of educational materials targeting healthcare professionals and patients.
4. What is the price for materials application to local health authority with their price list, if there is one? No application fee.
5. What type of educational material delivery has been accepted by SUKL (physical post, e-mail etc.)? In Guideline is written that physical post, e-mail or through medical representatives.
6. Can you advise 3rd party companies which could perform distribution (that have target groups- physicians contact information) by the method accepted by SUKL?
Yes in guideline is written that 3rd parties could be used. NJ Pharma has also their own database of HCP providers etc so we have experience with distribution of educational materials.
RMPs are shared on ŠÚKL and SÚKL website once approved.
