Regulatory Shorts#8 | How to get Marketing Authorisation in European Union (EU)? | Drug Registration

Welcome to the PharmaCamp with Neha. This is a small initiative from my side to share knowledge about the pharmaceutical world and regulatory, as I feel education is the best gift one can receive or give back to society.
Are you a working professional who wants to upgrade your skills? OR a student who wants to make a career in pharmaceuticals? OR are you a person who is interested to learn about the regulatory systems? Then this YouTube channel is for you.
About me:
I am Neha Parashar, working as a Associate Director in a pharmaceutical company and based in Germany. I am a passionate healthcare professional, an educator, and a mentor.

In this video, we will discuss - How to get Marketing Authorisation in European Union (EU)?

Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application

Series 2-Regulatory Shorts
Regulatory Shorts#2 | DSUR vs PSUR | Safety Reports

LinkedIn Articles on various Regulatory Topics:

3. Designing the Global Regulatory Strategy for the Development of Orphan Medicinal Products

Disclaimer- This video channel is for educational purposes. These are purely my views and not any recommendations. The channel does not represent the views of the organization I am associated with, and it has no connection with my current organization.

[sumanthkaranth]

Very useful information explained in simple words. Thanks a lot. Please keep making new videos

[Vmkavitha]

u made my day mam....I never understand MA this much easy than ur presentation....thanks a lot...expecting and requesting more content for LCMs and post approvals for EU

[nileshbawane]

Great Neha about clarification between MRP & DCP

[stutikamane]

Critical information in simple way
Can you please explain EU variation application and timelines procedure

[harshitamittal]

I was confused with these EU procedures..now all cleared thank you mam

[ronitahile]

Very Useful Information. Thank You Ma'am.

[mchitra]

Excellent presentation!! Very helpful for non-regulatory professionals like me:-)

[siddheshsanghavi]

Thank mam for the video but I want all the detail information about the submission process and documents which has to be submit for the veterinary drug in EU

[arpitjaiswal]

Very informative video Neha....keep it up....

[Vinay-cgik]

Such a helpful video, Madam. Can you please guide me to get RA job in the foreign countries?

[nileshbawane]

Kindly upload videos, regarding approval process timeline in detailed manner for all procedure

[anushkashinde]

Mam do u have any presentation regarding EU whole regulatory process

[prashant]

Sunset Clause: A legal provision stating that the marketing authorisation of a medicine will cease to be valid if the medicine is not placed on the market within three years of the authorisation being granted or
if the medicine is removed from the market for three consecutive years.

[nizemshaheenshaik]

Tq u so much ma'am..it was much useful. 🥰

[singh_deep]

Pls. Make a detailed video on CMC authoring part.

[deepakjena]

Madam we are planning to go for EU approval, Can you suggest from the beginning what steps we have to follow.

[AeshaPatel-gzio]

Which procedure is applicable for Abbreviated new drugs (Combination drugs) Application. I want to take Marketing authorization for all 27 countries in EU. In this case which procedure is applicable?

[sbhavan]

If one is ready to get MA for nanopharmaceuticals or nano drugs, which is MA mostly used for approval