Guideline on good pharmacovigilance practices …

1 Guideline on good pharmacovigilance practices (GVP) For Arab Countries Under the auspices of The League of Arab State Version 2 The League of Arab States Guideline on good pharmacovigilance practices (GVP) for Arab Countries Page 2 / 532 Guideline On good pharmacovigilance Practice For Arab Countries For Medicinal Products for Human Use - Guideline for Marketing Authorization Holders- 1st Published: March 2014 Effective: 1st July 2015 Version 2 - December 2014 Version 2 The League of Arab States Guideline on good pharmacovigilance practices (GVP) for Arab Countries Page 3 / 532 Versions change control Version No.

2 Version date Change section Changes Effective date for changes 01 3/2014 ------- ------- 02 12/2014 The Whole document Change in page numbering due to spacing & margin formatting Editorial improvements without impact on the content 1/7/2015 Contributors Editorial improvements Structure of GVP Clarification about timelines Module I Monitoring the performance & effectiveness of PV system and its quality system Addition of minor missing text Module II PSMF section on QPPV National PSSF section on LSR Provide more illustration on how to fill the table PSMF presentation Accessibility/ submission of PMSF National PSSF presentation Post -authorisation Correction of timeline Module V Editorial improvements throughout the Module without impact on its content Terminology Amended definition of Risk minimisation activity Terminology RMP module SVIII Summary of the safety concerns Amended definition of Missing information & safety concern RMP part III section Summary table of additional pharmacovigilance activities Requirements in specific situations

3 Simplification of requirements Version 2 The League of Arab States Guideline on good pharmacovigilance practices (GVP) for Arab Countries Page 4 / 532 (& its sub-sections ) RMP part VI Summary of activities in the RMP by medicinal product Amended sub-section of the RMP part VI Situations when a risk management plan should be submitted New situations added and Regarding the updates of RMP & their submission Module X Mandatory Scope Date correction Module XI , Module XII, Module XIV, P I, P II Change in the expected release date Module XVI- Risk minimization measures.

4 Selection of tools and effectiveness indicators Newly added Module Annex I definitions Amendments of definitions of Missing information (including its explanatory note) and Risk minimisation activity in accordance with update of Module V Annex II templates Annex Template of the Risk Management Plan (RMP) in integrated format Simplification of Part & Part VI Annex Template of the Risk Management Plan (RMP) for Generics Simplification of Part & Part VI Annex Template of the National Display of the Risk Management Plan (RMP) in the Arab Countries - for MAH/Applicant having Eu RMP Editorial improvements Version 2 The League of Arab States Guideline on good pharmacovigilance practices (GVP) for Arab Countries Page 5 / 532 Preface pharmacovigilance has been defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

5 This Guideline of the Arab Countries has been developed to bring guidance on the requirements, procedures, roles and activities in the field of human pharmacovigilance , for Marketing Authorization Holders (MAHs) of medicinal products for human use in the Arab Countries. This guidance describes the respective obligations of the MAH to set up a system for pharmacovigilance in order to collect, collate and evaluate information about suspected adverse reactions. All relevant information should be shared between medicines authority in Arab Countries and the MAH, in order to allow all parties involved in pharmacovigilance activities to assume their obligations and responsibilities.

6 The ultimate goal is to ensure that the MAHs are fulfilling their principal role in the safety monitoring of their medical products for human use, hence enhance efforts in ensuring that safe, efficacious, and quality medicines are made available for all patients in the Arab Countries. With the strategic objectives "to not reinvent the wheel" and "to keep up moreover- harmonise with the new development in pharmacovigilance practices & regulations"; this Guideline is greatly adopted from the European good pharmacovigilance practices (EU GVP) which considered the most compatible ICH pharmacovigilance Guideline thus the most widely applied pharmacovigilance practices in the developed European Countries.

7 The adoption of the EU GVP as a base for this Guideline does NOT undermine the right of a national medicines authority (NMA) in the Arab Countries to have additional or sometimes changed requirements. Multinational marketing authorization holders should be attentive to these national requirements and bring the attention of their headquarters to them, consequently, take the necessary measure to comply. This '' good pharmacovigilance Practice for Arab Countries'' (GVP- Arab) has been made to "harmonise the pharmacovigilance practices & regulations in-between the Arab Countries", though, it is understood that Arab Countries may have different healthcare and regulatory systems especially with regard to pharmacovigilance .

8 Accordingly, each national medicines authority in the Arab Countries should consider this Guideline as an ''ideal model'' which they try to adopt as much as they can on their national level whether at the time being or planned for the near future. Version 2 The League of Arab States Guideline on good pharmacovigilance practices (GVP) for Arab Countries Page 6 / 532 Each national medicines authority in the Arab Countries needs to decide on the following, as applicable on the national level: The implementing regulations. The date this Guideline become into effect.

9 The Transitional arrangements for the implementation by NMA or MAHs. However, if needed, the transitional period to become into force may differ in-between GVP modules ( PSUR, RMP ..etc.) If needed, any additional or changed requirements on the national level. It should be noted that, as with all guidance documents in rapidly evolving technical areas, that this guidance is intended to be regularly reviewed and updated. Version 2 The League of Arab States Guideline on good pharmacovigilance practices (GVP) for Arab Countries Page 7 / 532 Contributors In order to cope with these changes and to unify guidelines and performance across the Arab world, Arab ministers of health came to a common decree (number 7) in their 37th regular meeting in March 2012.

10 Under the umbrella of the Arab League The Higher Technical Committee for Medicines was established with representatives from all Arab countries, to create common Arab guidelines in pharmacovigilance , and in bioequivalence. This committee elected Dr. Amr Saad, head of the Egyptian centre, to lead the committee across all its rounds. The committee has finished the final drafts of the two common guidelines which were submitted to the 38th regular ministers meeting, and which has been approved by them. The new guidelines is mainly adapted from the newly-established international good pharmacovigilance Practice, composed of 16 different modules together with some product/population specific considerations, as well as annexes and templates of submission.