Saudi-Specific Annex (SSA)

When it is required

The MAH must submit the SSA whenever an EU RMP (or alternative RMP where no current EU RMP exists) is submitted in pre-marketing during registration and post marketing phase where the RMP is updated or required for submission.GVP v4.0 · V.B.10.9 · p. 135 ↗

The only situation where a SSA is not routinely required is if the RMP has been prepared specifically for Saudi Arabia.GVP v4.0 · V.B.10.9 · p. 135 ↗

Post-authorization RMPs can be submitted through e-mail (DS@sfda.gov.sa).GVP v4.0 · V.C.1 · p. 145 ↗

What it records

The Saudi‐specific annex (SSA) provides details not included in the EU RMP that enables the EU RMP (or, core or global RMP if no current EU RMP exists) to be adapted to the Saudi context. The SSA is required:

• To document any differences in safety concerns between the EU and Saudi (which may include differences in the frequency, severity or nature of safety concerns resulting from differences in the epidemiology of the indication and target population) and ensure that these are taken into account in determining an adequate risk management system
• To document any risk management activities not reflected in the EU RMP that are required to adequately address the safety concerns in Saudi Arabia (such as additional risk minimisation measures required by the SFDA)
• To record details of the dissemination and evaluation of effectiveness of risk minimisation activities in Saudi.
• To record milestones and timelines for reporting on additional pharmacovigilance and risk minimisation activities to the SFDA

GVP v4.0 · V.B.10.9 · p. 135 ↗

Contents of the SSA

Headings, fields and table columns as set out in V.B.10.9.1 “Format and content of the SSA”.

1. 1. Product details p. 136 ↗
   • Active ingredient(s):
   • Product name (s):
   • Marketing Authorization Holder (MAH):
   • SSA version:
   • Related EU-RMP version*:

   “*Can be changed to ‘core’ or ‘global’ RMP if no EU-RMP is available.”

2. 2. Safety specification p. 136 ↗
   • 2.1. Epidemiology of the indication(s) and target population(s) in Saudi Arabia p. 136 ↗

     “Include special considerations to genetic or extrinsic factors that are specific to the Saudi population.”

   • 2.2. Saudi-specific safety concerns p. 136 ↗

     “To list the important safety concerns relevant in the Saudi context.”

3. 3. Pharmacovigilance Plan p. 136 ↗
   • 3.1 Routine Pharmacovigilance activities in Saudi Arabia p. 136 ↗
   • 3.2 Additional Pharmacovigilance activities in Saudi Arabia p. 136 ↗

     Table 1: Summary table of additional pharmacovigilance activities in Saudi Arabia: p. 137 ↗

     Study and status	Objectives	Safety concerns addressed	Study location; Saudi patients included in the study?	Planned date for submission of (interim and) final results

4. 4. Risk minimization measures p. 137 ↗
   • 4.1 Saudi-specific routine risk minimization measures (required for all products) p. 137 ↗

     “You should provide a reference to the Saudi PIL and SPC sections, identify and justify any differences between the statements in the EU SPC and PIL, and Saudi SPC and PIL, with justification.”

     Table 2: Saudi-specific routine risk minimization measures: p. 138 ↗

     Safety concern	Routine risk minimization activities	Differences between EU and Saudi routine risk minimization activities, with justification
     Important identified risks
     Important potential risks
     Important missing information

   • 4.2 Additional risk minimization measures in Saudi Arabia p. 139 ↗

     “If there are no additional safety concerns for Saudi Arabia, and/or no Saudi-specific risk minimization activities for safety concerns listed in the EU-RMP then this can be simply stated.”

     Table 3: Additional risk minimization measures in Saudi Arabia p. 139 ↗

     Type of additional risk minimization activity	Objectives	Rationale for the additional risk minimization activity:	Saudi-specific additional risk minimization measures?

   • 4.3 How additional risk minimization measures will be implemented in Saudi Arabia. p. 140 ↗

     Table 4: Implementation of additional risk minimization measures in Saudi Arabia (example) p. 140 ↗

     Additional risk minimization measures	Target audience	Distribution scope	Risks addressed	Implementation details, including method(s) of dissemination	Distribution start date and frequency of repetition, if relevant)

   • 4.4. How additional risk minimization measures will be evaluated in Saudi Arabia p. 141 ↗

     “Your plan(s) to measure effectiveness should include a clear description of what defines success prior to implementation.”

     Table 5: indicators for evaluating the effectiveness of risk minimization measures:* p. 141 ↗

     Process indicators	Outcome indicators

     Table 6: Planning the evaluation of the effectiveness of risk minimization activities:* p. 142 ↗

     Additional risk minimization activity	Evaluation plan and criteria for success	Timeframe for conduction and results submission

5. 5. Appendix p. 142 ↗
   • <Protocols of additional pharmacovigilance activities>
   • <Draft of additional risk minimization measures that /will be implemented in Saudi Arabia>
   • <Protocols for the evaluation of the effectiveness of risk minimization activities in Saudi Arabia>
   • <Other related documents, if any>

RMP parts for an initial marketing authorization application

Table V.4. Summary of minimum RMP requirements for initial marketing authorization applications (for full description see text below) — p. 145 ↗