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.

This course will provide you, with all tools that you need to run all regulatory activities related to the pharmaceutical products starting from the registration, to place 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.

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

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

The MOHAP e-Transformation implemented by the MOH of the UAE in 11 April 2019, and still applicable so far as the latest regulations.

The eCTD software that you most probably use 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.

As the eCTD strructue as per bewlo:

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.

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

One of the Local DRA responsibilities 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 as a variation in the United Arab Emirates? we will see together.

And then we will end our interesting journey 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.