Master Pharmaceutical Products Registration In United Arab Emirates

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About Course

This course will prepare you, to be an expert in pharmaceutical products placement in the high-potential market of the United Arab Emirates. the business hub of the Middle East region.

 

We will take off together to the United Arab Emirates together, starting our journey with the classification, as the basic mandatory step for the regulation of any product ever with any health authority ever. as they do not follow blindly the COO classification.

Then we will prepare the LOA, with the explanation of the mandate of either legalization or notarization

What is notarization? and the notary list of countries?

Then we will transit for a while with UAE eCTD Implementation, and eCTD File Structure, with great focus and deep dive into  M1 insights.

We will prepare together the dossier for online submission for the conventional products

Products registered before 7 March 2016 need to be reformatted to e-CTD format.

The MOHAP e-Transformation was implemented by the MOH of the UAE on 11 April 2019 and is still applicable as far as the latest regulations.

The eCTD software that you most probably use is either:

EXTEDO eCTD Manager  (Corporate level). MOH website use.

LORENZ DocuBridge (Individual level).  for companies and local distributors to use.

With the e-CTD file we need to submit:-

Letter confirming that the DVD or CD does not contain any virus, validation report.   

The eCTD structure is as per below:

Module 1, Module 2, Module 3, Module 4 & Module 5

Module 1:

One of the Local DRA responsibilities is to guide the GRA in module 1.

Modules 2,3,4,5 from the Global side.

One of the Local DRA responsibilities is to Review the Stability section in module 3.

For sure the registration of the manufacturing site before/ or in parallel with the product registration file submission is mandatory.

With the mandate to provide legalized hard copies of the CPP, GMP, and ML.

Then our next short transit will be with the CPP and CEP. what is the difference? each for which finished product or API?

Does CEP change considered a variation in the United Arab Emirates? we will see together.

And then we will end our interesting journey of by-products Tracking, and tracing with the implementation and the mandate of the 2DMatrix barcode supported by the DHA and Abu Dhabi circulars issued by the subsidiary health entities of Dubai and Abu Dhabi, however, both are working under the umbrella of the MOH of the UAE.

Then we will do our landing with the most updated guidelines ever issued by the MOH of the UAE, which is Brand synchronization.

Congratulation on our journey completion.

I wish you have enjoyed our trip, best of luck to all of you, and see you soon successful in the pharma industry.

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What Will You Learn?

  • LOA
  • eCTD
  • M1 preparation
  • MOHAP e Transformation
  • MOHAP registration
  • Application process
  • Renewal
  • Variation
  • Minor variation
  • Variation list
  • Variation forms
  • Appendices
  • Tracking/tracing 
  • Updates
  • This course will provide you, with all tools that you need to run all regulatory activities related to pharmaceutical products starting from registration, to placing these pharmaceutical products in the high potential diverse market of the UAE, in Dubai, the GCC region business hub.
  • Then to perform post-market placement activities, such as renewal/Checklist/Application and variations “Major/Minor”
  • and variations appendices, in addition to pharmacovigilance.

Course Content

Module 1: Introduction
In this introduction, we will cover the below topics regarding the world of pharmaceutical products in the business hub of the Middle East Region. UAE Medical Devices Classification  Guide, LOA, Notarization/or Legalization, UAE eCTD Implementation  M1 insights, eCTD File Structure, MOHAP-e-Transformation, What is CPP?, Renewal/Checklist/Application, Variations “Major/Minor”, Variations Appendices, CEP is its variation in the UAE? So Let's fly to the UAE, let's fly to Dubai Have a nice trip.  

  • Introduction
    22:13

Module 2: LOA
In this section we will start our registration process by preparing the LOA, how it looks like? how to prepare it? legalized or notarized? and its validity

Module 3: e-CTD
This section is the introduction towards the e-CTD the actual shift from the CTD to the e-CTD with the MOH of the UAE, with deep focus on M1

Module 4: e-CTD (Module 1)
In this section we will dive deeply in M1, review its checklist, and how to prepare that list, how to build up the eCTD dossier tree using the XML backbone file type

Module 5: MOHAP e-Transformation
In this section we will go deeper to the registration process, we will explore together the MOHAP e-Transformation system, the actual manual, so let's practice.

Module 6: MOHAP- Drug Registration
In this section we will start the drug registration process with the MOHAP e System

Module 7: Attachments
In this section we will practice together the actual attachments to the MOHAP e system, let's prepare the attachments, let's practice

Module 8: The Renewal
In this section we will continue with the MOHAP e System with the renewal of products after we have submitted for the registration completely along with the attachments

Module 9: Actual Applications
In this section we will practice the actual forms, renewal forms for the site and the medicinal product as well, so let's practice

Module 10: Variations
In this section we will continue with MOHAP e System with the variations, let's practice.

Module 11: The Required Actions
In this section we will go deeper to the required actions and take them practically, so let's fulfil the requirements

Module 12: The Appendices
In this section let's practice the appendixes, let's see these appendixes and link them to what explained in our previous section, let's put all together.

Module 13: Minor Variation
Let's practice the minor variation list, discovering each case conditions, requirements, documents, tome frame with actual examples from practice

Module 14: Types of Variations
In this section we will continue with the list of different types of variations

Module 15: Minor Variation Lists
In this section we will continue with the list of minor variations, conditions, documents, time frame and examples

Module 16: Minor Variation List Continue
In this section we will continue with list of minor variations

Module 17: Variation Forms
In this section we will practice the variation forms. so, let's go

Module 18: Tracking & Tracing
In this section we reached the end of our interesting journey, and here I have to congratulate you for mastering pharmaceutical products registration in the UAE, whereas we will do our landing

Module 19: The Updates
Keep an eye on my last section of each course whereases you can find the latest updates, this is our major challenge of regulatory affairs profession is to keep up to date

Module 20: Renewal Updates
Renewal Updates

Module 21: MOHAP Tracking and Tracing
MOHAP Tracking and Tracing

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